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Prezista (darunavir) – Package leaflet - J05AE10

Updated on site: 09-Oct-2017

Medication namePrezista
ATC CodeJ05AE10
Substancedarunavir
ManufacturerJanssen-Cilag International NV

Package leaflet: Information for the user

PREZISTA 100 mg/ml oral suspension darunavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What PREZISTA is and what it is used for

2.What you need to know before you take PREZISTA

3.How to take PREZISTA

4.Possible side effects

5.How to store PREZISTA

6.Contents of the pack and other information

1.What PREZISTA is and what it is used for

What is PREZISTA?

PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?

PREZISTA is used to treat HIV infected adults as well as HIV infected children of 3 years of age and above, and at least 15 kilogram body weight (see How to take PREZISTA).

PREZISTA must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take PREZISTA

Do not take PREZISTA

-if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir.

-if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.

Do not combine PREZISTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Cisapride

to treat some stomach conditions

Colchicine (if you have kidney and/or liver

to treat gout or familial Mediterranean fever

problems)

 

Lurasidone, pimozide, quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine,

to treat migraine and headaches

dihydroergotamine, ergometrine and

 

methylergonovine

 

Amiodarone, bepridil, dronedarone, quinidine,

to treat certain heart disorders e.g. abnormal

ranolazine and systemic lidocaine

heart beat

Lovastatin and simvastatin

to lower cholesterol levels

Rifampicin

to treat some infections such as tuberculosis

The combination product lopinavir/ritonavir

this anti-HIV medicine belongs to the same class

 

as PREZISTA

Elbasvir/grazoprevir

to treat hepatitis C infection

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary

 

circulation

Ticagrelor

to help stop the clumping of platelets in the

 

treatment of patients with a history of a heart

 

attack

Do not combine PREZISTA with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PREZISTA.

PREZISTA is not a cure for HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment

Make sure that you check the following points and tell your doctor if any of these apply to you.

-Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.

-Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.

-Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

-In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of

the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

-Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.

-Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

-Tell your doctor if you notice any musculoskeletal problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children

PREZISTA is not for use in children younger than 3 years of age or weighing less than 15 kilograms.

Other medicines and PREZISTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with cobicistat or ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

-Phenobarbital, phenytoin (to prevent seizures)

-Dexamethasone (corticosteroid)

-Efavirenz (HIV infection)

-Telaprevir, boceprevir (hepatitis C infection)

-Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)

-Saquinavir (HIV infection).

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

-Apixaban, dabigatran etexilate, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

-Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

-Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle tissue disorder might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

-Clarithromycin (antibiotic)

-Ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

-Corticosteroids including bethametasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

-Buprenorphine/naloxone (medicines to treat opiate dependence)

-Salmeterol (medicine to treat asthma)

-Artemether/lumefantrine (a combination medicine to treat malaria)

-Dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)

-Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)

-Simeprevir (to treat hepatitis C infection).

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

-Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)

-Digoxin (to treat certain heart disorders)

-Clarithromycin (antibiotic)

-Ketoconazole, itraconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.

-Rifabutin (against bacterial infections)

-Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)

-Maraviroc (to treat HIV infection)

-Methadone (to treat opiate dependance)

-Carbamazepine (to prevent seizures or to treat certain types of nerve pain)

-Colchicine (to treat gout or familial Mediterranean fever)

-Bosentan (to treat high blood pressure in the pulmonary circulation)

-Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally, zoldipem (sedative agents)

-Perphenazine, risperidone, thioridazine (to treat psychiatric conditions)

-Metformin (to treat type 2 diabetes).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

PREZISTA with food and drink

See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking PREZISTA.

PREZISTA oral suspension contains sodium methyl parahydroxybenzoate. This ingredient may cause allergic reactions (sometimes delayed).

3.How to take PREZISTA

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor.

After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right once daily dose based on the weight of the child (see table below). This dose must not exceed the recommended adult dose, which is 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how much PREZISTA oral suspension and how much ritonavir (capsules, tablets or solution) the child must take.

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram (6 milliliter)

100 milligram (1.2 milliliter)

between 30 and 40 kilograms

675 milligram (6.8 milliliter)

100 milligram (1.2 milliliter)

more than 40 kilograms

800 milligram (8 milliliter)

100 milligram (1.2 milliliter)

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

The child must take PREZISTA every day and always in combination with 100 milligram of ritonavir and with food. PREZISTA cannot work properly without ritonavir and food. The child must eat a meal or a snack within 30 minutes prior to taking PREZISTA and ritonavir. The type of food is not important.

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right dose based on the weight of the child (see table below). The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligram PREZISTA together with

100 milligram ritonavir two times per day or 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how much PREZISTA oral suspension and how much ritonavir (capsules, tablets or solution) the child must take.

Twice daily dosing

 

Weight

 

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

 

380 milligram (3.8 milliliter)

50 milligram (0.6 milliliter)

between 30 and 40 kilograms

 

460 milligram (4.6 milliliter)

60 milligram (0.8 milliliter)

more than 40 kilograms

 

600 milligram (6 milliliter)

100 milligram (1.2 milliliter)

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Once daily dosing

 

 

 

 

Weight

 

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

 

600 milligram (6 milliliter)

100 milligram (1.2 milliliter)

between 30 and 40 kilograms

 

675 milligram (6.8 milliliter)

100 milligram (1.2 milliliter)

more than 40 kilograms

 

800 milligram (8 milliliter)

100 milligram (1.2 milliliter)

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Instructions for children

-The child must take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-The child must take the appropriate doses of PREZISTA and ritonavir two times per day or once a day. If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening. Your child’s doctor will determine the appropriate dosing regimen for your child.

-The child must take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)

The usual dose of PREZISTA is 800 milligram once daily.

You must take PREZISTA every day and always in combination with 150 milligram of cobicistat or 100 milligram of ritonavir and with food. PREZISTA cannot work properly without cobicistat or ritonavir and food. You must eat a meal or a snack within 30 minutes prior to taking your PREZISTA and cobicistat or ritonavir. The type of food is not important. Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)

The dose is either:

-600 milligram PREZISTA together with 100 milligram ritonavir twice daily. OR

-800 milligram PREZISTA together with 150 milligram cobicistat or100 milligram ritonavir once daily.

Please discuss with your doctor which dose is right for you.

Instructions for adults

-Take PREZISTA always together with cobicistat or ritonavir. PREZISTA cannot work properly without cobicistat or ritonavir.

-Take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

Instructions for use

Use the dosing pipette supplied with the pack to measure your dose accurately:

1.Shake the bottle well before each use.

2.Open the bottle of PREZISTA oral suspension by pushing downward on the cap and twisting it counter-clockwise.

3.Insert the supplied oral dosing pipette all the way into the bottle.

4.Pull the plunger until the top of the barrel meets the line that matches the dose prescribed by your health care provider.

5.Take the dose of PREZISTA. Place the tip of the oral dosing pipette in the mouth. Press on the plunger of the pipette towards the mouth, then swallow.

6.Close the bottle with the cap after use, and store PREZISTA oral suspension as directed in section 5 below.

7.Remove the plunger from the barrel of the pipette, rinse both with water and allow to air dry after each use.

8.Put the oral dosing pipette back together after air drying and store with the PREZISTA bottle.

Do not use the dosing pipette for any other medicines.

If you take more PREZISTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take PREZISTA

If you take PREZISTA two times a day and if you notice within 6 hours, you must take the oral suspension immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

If you take PREZISTA once a day and if you notice within 12 hours, you must take the oral suspension immediately. Always take with cobicistat or ritonavir and food. If you notice after

12 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking PREZISTA without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to contact your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.

Other clinically relevant severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)

-diarrhoea.

Common side effects (may affect up to 1 in 10 people)

-vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence

-headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance

-difficulty breathing, cough, nosebleed, throat irritation

-inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching

-kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night

-urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails

-muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis

-slowing down of the thyroid gland function. This can be seen in a blood test.

-high blood pressure, flushing

-red or dry eyes

-fever, swelling of lower limbs due to fluids, malaise, irritability, pain

-symptoms of infection, herpes simplex

-erectile dysfunction, enlargement of breasts

-sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)

-a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]

-heart attack, slow heart beating, palpitations

-visual disturbance

-chills, feeling abnormal

-a feeling of confusion or disorientation, altered mood, restlessness

-fainting, epileptic fits, changes or loss of taste

-mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue

-running nose

-skin lesions, dry skin

-stiffness of muscles or joints, joint pain with or without inflammation

-changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

-muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store PREZISTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not refrigerate or freeze. Avoid exposure to excessive heat.

Store in the original container.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What PREZISTA contains

-The active substance is darunavir. Each milliliter contains 100 milligram of darunavir (as ethanolate).

-The other ingredients are hydroxypropylcellulose, microcrystalline cellulose and carmellose sodium, citric acid monohydrate, sucralose, strawberry cream flavour, masking flavour, sodium methyl parahydroxybenzoate (E219), hydrocholoric acid (for pH adjustment), purified water.

What PREZISTA looks like and contents of the pack

White to off-white opaque oral suspension. Provided in a 200 ml amber glass bottle with polypropylene child resistant closure and a 6 ml low density polyethylene (LDPE) oral dosing pipette with 0.2 ml gradations. The bottle neck is filled with a low density polyethylene (LDPE) insert that accomodates the dosing pipette. Do not use the oral dosing pipette for any other medicines. PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 400 milligram,

600 milligram and 800 milligram film-coated tablets.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Manufacturer

Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Janssen-Cilag NV

UAB "JOHNSON & JOHNSON"

Antwerpseweg 15-17

Geležinio Vilko g. 18A

B-2340 Beerse

LT-08104 Vilnius

Tel/Tél: +32 14 64 94 11

Tel: +370 5 278 68 88

България

Luxembourg/Luxemburg

„Джонсън & Джонсън България” ЕООД

Janssen-Cilag NV

ж.к. Младост 4

Antwerpseweg 15-17

Бизнес Парк София, сграда 4

B-2340 Beerse

София 1766

Belgique/Belgien

Тел.: +359 2 489 94 00

Tél/Tel: +32 14 64 94 11

Česká republika

Magyarország

Janssen-Cilag s.r.o.

Janssen-Cilag Kft.

Karla Engliše 3201/06

Nagyenyed u. 8-14

CZ-150 00 Praha 5 - Smíchov

H-Budapest, 1123

Tel: +420 227 012 227

Tel.: +36 1 884 2858

Danmark

Malta

Janssen-Cilag A/S

AM MANGION LTD.

Bregnerødvej 133

Mangion Building, Triq Ġdida fi Triq Valletta

DK-3460 Birkerød

MT-Ħal-Luqa LQA 6000

Tlf: +45 45 94 82 82

Tel: +356 2397 6000

Deutschland

Nederland

Janssen-Cilag GmbH

Janssen-Cilag B.V.

Johnson & Johnson Platz 1

Graaf Engelbertlaan 75

D-41470 Neuss

NL-4837 DS Breda

Tel: +49 2137 955-955

Tel: +31 76 711 1111

Eesti

Norge

UAB "JOHNSON & JOHNSON" Eesti filiaal

Janssen-Cilag AS

Lõõtsa 2

Postboks 144

EE-11415 Tallinn

NO-1325-Lysaker

Tel: +372 617 7410

Tlf: +47 24 12 65 00

Ελλάδα

Österreich

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.

Janssen-Cilag Pharma GmbH

Λεωφόρος Ειρήνης 56

Vorgartenstraße 206B

GR-151 21 Πεύκη, Αθήνα

A-1020 Wien

Tηλ: +30 210 80 90 000

Tel: +43 1 610 300

España

Polska

Janssen-Cilag, S.A.

Janssen-Cilag Polska Sp. z o.o.

ul. Iłżecka 24

E-28042 Madrid

PL-02-135 Warszawa

Tel: +34 91 722 81 00

Tel.: +48 22 237 60 00

France

Portugal

Janssen-Cilag

Janssen-Cilag Farmacêutica, Lda.

1, rue Camille Desmoulins, TSA 91003

Estrada Consiglieri Pedroso, 69 A

F-92787 Issy Les Moulineaux, Cedex 9

Queluz de Baixo

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

PT-2734-503 Barcarena

 

Tel: +351 21 43 68 835

Hrvatska

România

Johnson & Johnson S.E. d.o.o.

Johnson & Johnson România SRL

Oreškovićeva 6h

Str. Tipografilor nr. 11-15

10010 Zagreb

Clădirea S-Park, Corp B3-B4, Etaj 3

Tel: +385 1 6610 700

013714 Bucureşti, ROMÂNIA

 

Tel: +40 21 207 1800

Ireland

Slovenija

Janssen-Cilag Ltd.

Johnson & Johnson d.o.o.

50-100 Holmers Farm Way

Šmartinska cesta 53

High Wycombe

SI-1000 Ljubljana

Buckinghamshire HP12 4EG

Tel: +386 1 401 18 30

United Kingdom

 

Tel: +44 1 494 567 444

 

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

PREZISTA 75 mg film-coated tablets darunavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.What PREZISTA is and what it is used for

2.What you need to know before you take PREZISTA

3.How to take PREZISTA

4.Possible side effects

5.How to store PREZISTA

6.Contents of the pack and other information

1. What PREZISTA is and what it is used for

What is PREZISTA?

PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?

PREZISTA is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.

PREZISTA must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take PREZISTA

Do not take PREZISTA

-if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.

-if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.

Do not combine PREZISTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Cisapride

to treat some stomach conditions

Colchicine (if you have kidney and/or liver

to treat gout or familial Mediterranean fever

problems)

 

Lurasidone, pimozide, quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine,

to treat migraine and headaches

dihydroergotamine, ergometrine and

 

methylergonovine

 

Amiodarone, bepridil, dronedarone, quinidine,

to treat certain heart disorders e.g. abnormal

ranolazine and systemic lidocaine

heart beat

Lovastatin and simvastatin

to lower cholesterol levels

Rifampicin

to treat some infections such as tuberculosis

The combination product lopinavir/ritonavir

this anti-HIV medicine belongs to the same class

 

as PREZISTA

Elbasvir/grazoprevir

to treat hepatitis C infection

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary

 

circulation

Ticagrelor

to help stop the clumping of platelets in the

 

treatment of patients with a history of a heart

 

attack

Do not combine PREZISTA with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PREZISTA.

PREZISTA is not a cure for HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment

Make sure that you check the following points and tell your doctor if any of these apply to you.

-Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.

-Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.

-Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

-In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of

the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

-Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.

-Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

-Tell your doctor if you notice any musculoskeletal problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children

PREZISTA is not for use in children younger than 3 years of age or weighing less than 15 kilograms.

Other medicines and PREZISTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

-Phenobarbital, phenytoin (to prevent seizures)

-Dexamethasone (corticosteroid)

-Efavirenz (HIV infection)

-Telaprevir, boceprevir (hepatitis C infection)

-Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)

-Saquinavir (HIV infection).

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

-Apixaban, dabigatran etexilate, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

-Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

-Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle tissue disorder might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

-Clarithromycin (antibiotic)

-Ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

-Corticosteroids including bethametasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

-Buprenorphine/naloxone (medicines to treat opiate dependence)

-Salmeterol (medicine to treat asthma)

-Artemether/lumefantrine (a combination medicine to treat malaria)

-Dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)

-Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)

-Simeprevir (to treat hepatitis C infection).

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

-Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)

-Digoxin (to treat certain heart disorders)

-Clarithromycin (antibiotic)

-Ketoconazole, itraconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.

-Rifabutin (against bacterial infections)

-Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)

-Maraviroc (to treat HIV infection)

-Methadone (to treat opiate dependance)

-Carbamazepine (to prevent seizures or to treat certain types of nerve pain)

-Colchicine (to treat gout or familial Mediterranean fever)

-Bosentan (to treat high blood pressure in the pulmonary circulation)

-Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally, zoldipem (sedative agents)

-Risperidone, thioridazine (to treat psychiatric conditions).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

PREZISTA with food and drink

See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking PREZISTA.

3. How to take PREZISTA

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Even if you feel better, do not stop taking PREZISTA and ritonavir without talking to your doctor.

After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right once daily dose based on the weight of the child (see table below). This dose must not exceed the recommended adult dose, which is 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how much PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take.

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right dose based on the weight of the child (see table below). The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligram PREZISTA together with

100 milligram ritonavir two times per day or 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how many PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take. Tablets of other strengths are available and your doctor may have prescribed a certain combination of tablets to construct the appropriate dosing regimen. PREZISTA oral suspension is also available. Your doctor will determine whether PREZISTA tablets or oral suspension is right for the child.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram PREZISTA + 50 milligram ritonavir twice a day

between 30 and 40 kilograms

450 milligram PREZISTA + 60 milligram ritonavir twice a day

more than 40 kilograms*

600 milligram PREZISTA + 100 milligram ritonavir twice a day

*For children aged 12 or more and weighing at least 40 kilograms, your child’s doctor will determine if PREZISTA 800 milligram once daily dosing may be used. This cannot be administered with these 75 milligram tablets. Other strengths of PREZISTA are available.

Once daily dosing

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Instructions for children

-The child must take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-The child must take the appropriate doses of PREZISTA and ritonavir two times per day or once a day. If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening. Your child’s doctor will determine the appropriate dosing regimen for your child.

-The child must take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-The child must swallow the tablets with a drink such as water or milk.

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)

You will require a different dose of PREZISTA which cannot be administered with these 75 milligram tablets. Other strengths of PREZISTA are available.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)

The dose is either:

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily. OR

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily. PREZISTA 400 milligram and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.

Please discuss with your doctor which dose is right for you.

Instructions for adults

-Take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-In the morning, take 600 milligram PREZISTA together with 100 milligram ritonavir.

-In the evening, take 600 milligram PREZISTA together with 100 milligram ritonavir.

-Take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-Swallow the tablets with a drink such as water or milk.

-PREZISTA 75 milligram and 150 milligram tablets and 100 milligram per milliliter oral suspension have been developed for use in children, but can also be used in adults in some cases.

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and must be opened as follows:

-Push the plastic screw cap down while turning it counter clockwise.

-Remove the unscrewed cap.

If you take more PREZISTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take PREZISTA

If you notice within 6 hours, you must take the tablets immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking PREZISTA without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to contact your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.

Other clinically relevant severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)

-diarrhoea.

Common side effects (may affect up to 1 in 10 people)

-vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence

-headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance

-difficulty breathing, cough, nosebleed, throat irritation

-inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching

-kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night

-urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails

-muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis

-slowing down of the thyroid gland function. This can be seen in a blood test.

-high blood pressure, flushing

-red or dry eyes

-fever, swelling of lower limbs due to fluids, malaise, irritability, pain

-symptoms of infection, herpes simplex

-erectile dysfunction, enlargement of breasts

-sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)

-a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]

-heart attack, slow heart beating, palpitations

-visual disturbance

-chills, feeling abnormal

-a feeling of confusion or disorientation, altered mood, restlessness

-fainting, epileptic fits, changes or loss of taste

-mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue

-running nose

-skin lesions, dry skin

-stiffness of muscles or joints, joint pain with or without inflammation

-changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

-muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PREZISTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.

PREZISTA does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What PREZISTA contains

-The active substance is darunavir. Each tablet contains 75 milligram of darunavir (as ethanolate).

-The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate. The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc.

What PREZISTA looks like and contents of the pack

Film-coated, white, caplet shaped tablet, mentioning TMC on one side, 75 on the other side. 480 tablets in a plastic bottle.

PREZISTA is also available as 150 milligram, 300 milligram, 400 milligram, 600 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél: +32 14 64 94 11

България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766

Тел.: +359 2 489 94 00

Česká republika

Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov Tel: +420 227 012 227

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

España

Janssen-Cilag, S.A.

E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A

LT-08104 Vilnius

Tel: +370 5 278 68 88

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: +32 14 64 94 11

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

Hrvatska

România

Johnson & Johnson S.E. d.o.o.

Johnson & Johnson România SRL

Oreškovićeva 6h

Str. Tipografilor nr. 11-15

10010 Zagreb

Clădirea S-Park, Corp B3-B4, Etaj 3

Tel: +385 1 6610 700

013714 Bucureşti, ROMÂNIA

 

Tel: +40 21 207 1800

Ireland

Slovenija

Janssen-Cilag Ltd.

Johnson & Johnson d.o.o.

50-100 Holmers Farm Way

Šmartinska cesta 53

High Wycombe

SI-1000 Ljubljana

Buckinghamshire HP12 4EG

Tel: +386 1 401 18 30

United Kingdom

 

Tel: +44 1 494 567 444

 

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

PREZISTA 150 mg film-coated tablets darunavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.What PREZISTA is and what it is used for

2.What you need to know before you take PREZISTA

3.How to take PREZISTA

4.Possible side effects

5.How to store PREZISTA

6.Contents of the pack and other information

1. What PREZISTA is and what it is used for

What is PREZISTA?

PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?

PREZISTA is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.

PREZISTA must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take PREZISTA

Do not take PREZISTA

-if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.

-if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.

Do not combine PREZISTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Cisapride

to treat some stomach conditions

Colchicine (if you have kidney and/or liver

to treat gout or familial Mediterranean fever

problems)

 

Lurasidone, pimozide, quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine,

to treat migraine and headaches

dihydroergotamine, ergometrine and

 

methylergonovine

 

Amiodarone, bepridil, dronedarone, quinidine,

to treat certain heart disorders e.g. abnormal

ranolazine and systemic lidocaine

heart beat

Lovastatin and simvastatin

to lower cholesterol levels

Rifampicin

to treat some infections such as tuberculosis

The combination product lopinavir/ritonavir

this anti-HIV medicine belongs to the same class

 

as PREZISTA

Elbasvir/grazoprevir

to treat hepatitis C infection

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary

 

circulation

Ticagrelor

to help stop the clumping of platelets in the

 

treatment of patients with a history of a heart

 

attack

Do not combine PREZISTA with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PREZISTA.

PREZISTA is not a cure for HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment

Make sure that you check the following points and tell your doctor if any of these apply to you.

-Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.

-Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.

-Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

-In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of

the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

-Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.

-Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

-Tell your doctor if you notice any musculoskeletal problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children

PREZISTA is not for use in children younger than 3 years of age or weighing less than 15 kilograms.

Other medicines and PREZISTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

-Phenobarbital, phenytoin (to prevent seizures)

-Dexamethasone (corticosteroid)

-Efavirenz (HIV infection)

-Telaprevir, boceprevir (hepatitis C infection)

-Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)

-Saquinavir (HIV infection).

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

-Apixaban, dabigatran etexilate, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

-Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

-Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle tissue disorder might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

-Clarithromycin (antibiotic)

-Ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

-Corticosteroids including bethametasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

-Buprenorphine/naloxone (medicines to treat opiate dependence)

-Salmeterol (medicine to treat asthma)

-Artemether/lumefantrine (a combination medicine to treat malaria)

-Dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)

-Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)

-Simeprevir (to treat hepatitis C infection).

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

-Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)

-Digoxin (to treat certain heart disorders)

-Clarithromycin (antibiotic)

-Ketoconazole, itraconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.

-Rifabutin (against bacterial infections)

-Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)

-Maraviroc (to treat HIV infection)

-Methadone (to treat opiate dependance)

-Carbamazepine (to prevent seizures or to treat certain types of nerve pain)

-Colchicine (to treat gout or familial Mediterranean fever)

-Bosentan (to treat high blood pressure in the pulmonary circulation)

-Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally, zoldipem (sedative agents)

-Risperidone, thioridazine (to treat psychiatric conditions).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

PREZISTA with food and drink

See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking PREZISTA.

3. How to take PREZISTA

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Even if you feel better, do not stop taking PREZISTA and ritonavir without talking to your doctor.

After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right once daily dose based on the weight of the child (see table below). This dose must not exceed the recommended adult dose, which is 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how much PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take.

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right dose based on the weight of the child (see table below). The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligram PREZISTA together with

100 milligram ritonavir two times per day or 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how many PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take. Tablets of other strengths are available and your doctor may have prescribed a certain combination of tablets to construct the appropriate dosing regimen. PREZISTA oral suspension is also available. Your doctor will determine whether PREZISTA tablets or oral suspension is right for the child.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram PREZISTA + 50 milligram ritonavir twice a day

between 30 and 40 kilograms

450 milligram PREZISTA + 60 milligram ritonavir twice a day

more than 40 kilograms*

600 milligram PREZISTA + 100 milligram ritonavir twice a day

*For children aged 12 or more and weighing at least 40 kilograms, your child’s doctor will determine if PREZISTA 800 milligram once daily dosing may be used. This cannot be administered with these 150 milligram tablets. Other strengths of PREZISTA are available.

Once daily dosing

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Instructions for children

-The child must take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-The child must take the appropriate doses of PREZISTA and ritonavir two times per day or once a day. If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening. Your child’s doctor will determine the appropriate dosing regimen for your child.

-The child must take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-The child must swallow the tablets with a drink such as water or milk.

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)

You will require a different dose of PREZISTA which cannot be administered with these 150 milligram tablets. Other strengths of PREZISTA are available.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)

The dose is either:

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily. OR

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily. PREZISTA 400 milligram and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.

Please discuss with your doctor which dose is right for you.

Instructions for adults

-Take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-In the morning, take 600 milligram PREZISTA together with 100 milligram ritonavir.

-In the evening, take 600 milligram PREZISTA together with 100 milligram ritonavir.

-Take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-Swallow the tablets with a drink such as water or milk.

-PREZISTA 75 milligram and 150 milligram tablets and 100 milligram per milliliter oral suspension have been developed for use in children, but can also be used in adults in some cases.

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and must be opened as follows:

-Push the plastic screw cap down while turning it counter clockwise.

-Remove the unscrewed cap.

If you take more PREZISTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take PREZISTA

If you notice within 6 hours, you must take the tablets immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking PREZISTA without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to contact your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.

Other clinically relevant severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)

-diarrhoea.

Common side effects (may affect up to 1 in 10 people)

-vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence

-headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance

-difficulty breathing, cough, nosebleed, throat irritation

-inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching

-kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night

-urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails

-muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis

-slowing down of the thyroid gland function. This can be seen in a blood test.

-high blood pressure, flushing

-red or dry eyes

-fever, swelling of lower limbs due to fluids, malaise, irritability, pain

-symptoms of infection, herpes simplex

-erectile dysfunction, enlargement of breasts

-sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)

-a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]

-heart attack, slow heart beating, palpitations

-visual disturbance

-chills, feeling abnormal

-a feeling of confusion or disorientation, altered mood, restlessness

-fainting, epileptic fits, changes or loss of taste

-mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue

-running nose

-skin lesions, dry skin

-stiffness of muscles or joints, joint pain with or without inflammation

-changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

-muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PREZISTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.

PREZISTA does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What PREZISTA contains

-The active substance is darunavir. Each tablet contains 150 milligram of darunavir (as ethanolate).

-The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate. The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc.

What PREZISTA looks like and contents of the pack

Film-coated, white, oval shaped tablet, mentioning TMC on one side, 150 on the other side. 240 tablets in a plastic bottle.

PREZISTA is also available as 75 milligram, 300 milligram, 400 milligram, 600 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél: +32 14 64 94 11

България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766

Тел.: +359 2 489 94 00

Česká republika

Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov Tel: +420 227 012 227

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

España

Janssen-Cilag, S.A.

E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A

LT-08104 Vilnius

Tel: +370 5 278 68 88

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: +32 14 64 94 11

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

Hrvatska

România

Johnson & Johnson S.E. d.o.o.

Johnson & Johnson România SRL

Oreškovićeva 6h

Str. Tipografilor nr. 11-15

10010 Zagreb

Clădirea S-Park, Corp B3-B4, Etaj 3

Tel: +385 1 6610 700

013714 Bucureşti, ROMÂNIA

 

Tel: +40 21 207 1800

Ireland

Slovenija

Janssen-Cilag Ltd.

Johnson & Johnson d.o.o.

50-100 Holmers Farm Way

Šmartinska cesta 53

High Wycombe

SI-1000 Ljubljana

Buckinghamshire HP12 4EG

Tel: +386 1 401 18 30

United Kingdom

 

Tel: +44 1 494 567 444

 

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

PREZISTA 300 mg film-coated tablets darunavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.What PREZISTA is and what it is used for

2.What you need to know before you take PREZISTA

3.How to take PREZISTA

4.Possible side effects

5.How to store PREZISTA

6.Contents of the pack and other information

1. What PREZISTA is and what it is used for

What is PREZISTA?

PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?

PREZISTA is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.

PREZISTA must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take PREZISTA

Do not take PREZISTA

-if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.

-if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.

Do not combine PREZISTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Cisapride

to treat some stomach conditions

Colchicine (if you have kidney and/or liver

to treat gout or familial Mediterranean fever

problems)

 

Lurasidone, pimozide, quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine,

to treat migraine and headaches

dihydroergotamine, ergometrine and

 

methylergonovine

 

Amiodarone, bepridil, dronedarone, quinidine,

to treat certain heart disorders e.g. abnormal

ranolazine and systemic lidocaine

heart beat

Lovastatin and simvastatin

to lower cholesterol levels

Rifampicin

to treat some infections such as tuberculosis

The combination product lopinavir/ritonavir

this anti-HIV medicine belongs to the same class

 

as PREZISTA

Elbasvir/grazoprevir

to treat hepatitis C infection

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary

 

circulation

Ticagrelor

to help stop the clumping of platelets in the

 

treatment of patients with a history of a heart

 

attack

Do not combine PREZISTA with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PREZISTA.

PREZISTA is not a cure for HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment

Make sure that you check the following points and tell your doctor if any of these apply to you.

-Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.

-Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.

-Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

-In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of

the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

-Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.

-Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

-Tell your doctor if you notice any musculoskeletal problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children

PREZISTA is not for use in children younger than 3 years of age or weighing less than 15 kilograms.

Other medicines and PREZISTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

-Phenobarbital, phenytoin (to prevent seizures)

-Dexamethasone (corticosteroid)

-Efavirenz (HIV infection)

-Telaprevir, boceprevir (hepatitis C infection)

-Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)

-Saquinavir (HIV infection).

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

-Apixaban, dabigatran etexilate, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

-Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

-Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle tissue disorder might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

-Clarithromycin (antibiotic)

-Ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

-Corticosteroids including bethametasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

-Buprenorphine/naloxone (medicines to treat opiate dependence)

-Salmeterol (medicine to treat asthma)

-Artemether/lumefantrine (a combination medicine to treat malaria)

-Dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)

-Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)

-Simeprevir (to treat hepatitis C infection).

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

-Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)

-Digoxin (to treat certain heart disorders)

-Clarithromycin (antibiotic)

-Ketoconazole, itraconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.

-Rifabutin (against bacterial infections)

-Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)

-Maraviroc (to treat HIV infection)

-Methadone (to treat opiate dependance)

-Carbamazepine (to prevent seizures or to treat certain types of nerve pain)

-Colchicine (to treat gout or familial Mediterranean fever)

-Bosentan (to treat high blood pressure in the pulmonary circulation)

-Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally, zoldipem (sedative agents)

-Risperidone, thioridazine (to treat psychiatric conditions).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

PREZISTA with food and drink

See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking PREZISTA.

PREZISTA tablets contain sunset yellow FCF (E110) which may cause allergic reactions.

3. How to take PREZISTA

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Even if you feel better, do not stop taking PREZISTA and ritonavir without talking to your doctor.

After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)

You will require a different dose of PREZISTA which cannot be administered with these 300 milligram tablets. Other strengths of PREZISTA are available.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)

The dose is either:

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily. OR

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily. PREZISTA 400 milligram and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.

Please discuss with your doctor which dose is right for you.

Instructions for adults

-Take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-In the morning, take two 300 milligram PREZISTA tablets together with 100 milligram ritonavir.

-In the evening, take two 300 milligram PREZISTA tablets together with 100 milligram ritonavir.

-Take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-Swallow the tablets with a drink such as water or milk.

-PREZISTA 75 milligram and 150 milligram tablets and 100 milligram per milliliter oral suspension have been developed for use in children, but can also be used in adults in some cases.

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right once daily dose based on the weight of the child (see table below). This dose must not exceed the recommended adult dose, which is 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how much PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take.

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right dose based on the weight of the child (see table below). The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligram PREZISTA together with

100 milligram of ritonavir two times per day or 800 milligram PREZISTA together with

100 milligram ritonavir once a day. The doctor will inform you on how many PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take. Tablets of lower strengths are available and your doctor may have prescribed a certain combination of tablets to construct the appropriate dosing regimen. PREZISTA oral suspension is also available. Your doctor will determine whether PREZISTA tablets or oral suspension is right for the child.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram PREZISTA + 50 milligram ritonavir twice a day

between 30 and 40 kilograms

450 milligram PREZISTA + 60 milligram ritonavir twice a day

more than 40 kilograms*

600 milligram PREZISTA + 100 milligram ritonavir twice a day

*For children aged 12 or more and weighing at least 40 kilograms, your child’s doctor will determine if PREZISTA 800 milligram once daily dosing may be used. This cannot be administered with these 300 milligram tablets. Other strengths of PREZISTA are available.

Once daily dosing

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Instructions for children

-The child must take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-The child must take the appropriate doses of PREZISTA and ritonavir two times per day or once a day. If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening. Your child’s doctor will determine the appropriate dosing regimen for your child.

-The child must take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-The child must swallow the tablets with a drink such as water or milk.

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and must be opened as follows:

-Push the plastic screw cap down while turning it counter clockwise.

-Remove the unscrewed cap.

If you take more PREZISTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take PREZISTA

If you notice within 6 hours, you must take the tablets immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking PREZISTA without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to contact your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.

Other clinically relevant severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)

-diarrhoea.

Common side effects (may affect up to 1 in 10 people)

-vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence

-headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance

-difficulty breathing, cough, nosebleed, throat irritation

-inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching

-kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night

-urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails

-muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis

-slowing down of the thyroid gland function. This can be seen in a blood test.

-high blood pressure, flushing

-red or dry eyes

-fever, swelling of lower limbs due to fluids, malaise, irritability, pain

-symptoms of infection, herpes simplex

-erectile dysfunction, enlargement of breasts

-sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)

-a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]

-heart attack, slow heart beating, palpitations

-visual disturbance

-chills, feeling abnormal

-a feeling of confusion or disorientation, altered mood, restlessness

-fainting, epileptic fits, changes or loss of taste

-mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue

-running nose

-skin lesions, dry skin

-stiffness of muscles or joints, joint pain with or without inflammation

-changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

-muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PREZISTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.

PREZISTA does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What PREZISTA contains

-The active substance is darunavir. Each tablet contains 300 milligram of darunavir (as ethanolate).

-The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate. The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, sunset yellow FCF (E110).

What PREZISTA looks like and contents of the pack

Film-coated, orange, oval shaped tablet, mentioning TMC114 on one side, 300MG on the other side. 120 tablets in a plastic bottle.

PREZISTA is also available as 75 milligram, 150 milligram, 400 milligram, 600 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél: +32 14 64 94 11

България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766

Тел.: +359 2 489 94 00

Česká republika

Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov Tel: +420 227 012 227

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A

LT-08104 Vilnius

Tel: +370 5 278 68 88

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: +32 14 64 94 11

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300

España

Janssen-Cilag, S.A.

Paseo de las Doce Estrellas, 5-7 E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h

10010 Zagreb

Tel: +385 1 6610 700

Ireland

Janssen-Cilag Ltd.

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Tel: +44 1 494 567 444

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

România

Johnson & Johnson România SRL Str. Tipografilor nr. 11-15

Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA

Tel: +40 21 207 1800

Slovenija

Johnson & Johnson d.o.o. Šmartinska cesta 53 SI-1000 Ljubljana

Tel: +386 1 401 18 30

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

PREZISTA 400 mg film-coated tablets darunavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.What PREZISTA is and what it is used for

2.What you need to know before you take PREZISTA

3.How to take PREZISTA

4.Possible side effects

5.How to store PREZISTA

6.Contents of the pack and other information

1. What PREZISTA is and what it is used for

What is PREZISTA?

PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?

The PREZISTA 400 milligram tablet is used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and

-who have not used antiretroviral medicines before.

-in certain patients who have used antiretroviral medicines before (your doctor will determine this).

PREZISTA must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take PREZISTA

Do not take PREZISTA

-if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir.

-if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.

Do not combine PREZISTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Cisapride

to treat some stomach conditions

Colchicine (if you have kidney and/or liver

to treat gout or familial Mediterranean fever

problems)

 

Lurasidone, pimozide, quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine,

to treat migraine and headaches

dihydroergotamine, ergometrine and

 

methylergonovine

 

Amiodarone, bepridil, dronedarone, quinidine,

to treat certain heart disorders e.g. abnormal

ranolazine and systemic lidocaine

heart beat

Lovastatin and simvastatin

to lower cholesterol levels

Rifampicin

to treat some infections such as tuberculosis

The combination product lopinavir/ritonavir

this anti-HIV medicine belongs to the same class

 

as PREZISTA

Elbasvir/grazoprevir

to treat hepatitis C infection

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary

 

circulation

Ticagrelor

to help stop the clumping of platelets in the

 

treatment of patients with a history of a heart

 

attack

Do not combine PREZISTA with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PREZISTA.

PREZISTA is not a cure for HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment

Make sure that you check the following points and tell your doctor if any of these apply to you.

-Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.

-Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.

-Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

-In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after

the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

-Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.

-Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

-Tell your doctor if you notice any musculoskeletal problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children and adolescents

The PREZISTA 400 milligram tablet is not for use in children younger than 3 years of age or weighing less than 40 kilograms.

Other medicines and PREZISTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with cobicistat or ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

-Phenobarbital, phenytoin (to prevent seizures)

-Dexamethasone (corticosteroid)

-Efavirenz (HIV infection)

-Telaprevir, boceprevir (hepatitis C infection)

-Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)

-Saquinavir (HIV infection).

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

-Apixaban, dabigatran etexilate, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

-Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

-Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle tissue disorder might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

-Clarithromycin (antibiotic)

-Ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

-Corticosteroids including bethametasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

-Buprenorphine/naloxone (medicines to treat opiate dependence)

-Salmeterol (medicine to treat asthma)

-Artemether/lumefantrine (a combination medicine to treat malaria)

-Dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)

-Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)

-Simeprevir (to treat hepatitis C infection).

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

-Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)

-Digoxin (to treat certain heart disorders)

-Clarithromycin (antibiotic)

-Ketoconazole, itraconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.

-Rifabutin (against bacterial infections)

-Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)

-Maraviroc (to treat HIV infection)

-Methadone (to treat opiate dependance)

-Carbamazepine (to prevent seizures or to treat certain types of nerve pain)

-Colchicine (to treat gout or familial Mediterranean fever)

-Bosentan (to treat high blood pressure in the pulmonary circulation)

-Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally, zoldipem (sedative agents)

-Perphenazine, risperidone, thioridazine (to treat psychiatric conditions)

-Metformin (to treat type 2 diabetes).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

PREZISTA with food and drink

See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking PREZISTA.

PREZISTA tablets contain sunset yellow FCF (E110) which may cause allergic reactions.

3. How to take PREZISTA

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor.

After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.

PREZISTA 400 milligram tablets are only to be used to construct the once daily 800 milligram regimen.

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)

The usual dose of PREZISTA is 800 milligram (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) once daily.

You must take PREZISTA every day and always in combination with 150 milligram of cobicistat or 100 milligram of ritonavir and with food. PREZISTA cannot work properly without cobicistat or ritonavir and food. You must eat a meal or a snack within 30 minutes prior to taking your PREZISTA and cobicistat or ritonavir. The type of food is not important. Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor.

Instructions for adults

-Take two 400 milligram tablets at the same time, once a day, every day.

-Take PREZISTA always together with 150 milligram of cobicistat or100 milligram of ritonavir.

-Take PREZISTA with food.

-Swallow the tablets with a drink such as water or milk.

-Take your other HIV medicines used in combination with PREZISTA and cobicistat or ritonavir as recommended by your doctor.

-PREZISTA 100 milligram per milliliter oral suspension has been developed for use in children, but can also be used in adults in some cases.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)

The dose is either:

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 150 milligram cobicistat or

100 milligram ritonavir once daily. OR

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily.

Please discuss with your doctor which dose is right for you.

Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this)

-The usual dose of PREZISTA is 800 milligram (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily.

Dose for children 3 years of age and above, weighing more than 40 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this)

The dose is either:

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily. OR

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily.

Please discuss with your doctor which dose is right for you.

Instructions for children 3 years of age and above, weighing more than 40 kilograms

-Take 800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) at the same time, once a day, every day.

-Take PREZISTA always together with 100 milligram of ritonavir.

-Take PREZISTA with food.

-Swallow the tablets with a drink such as water or milk.

-Take your other HIV medicines used in combination with PREZISTA and ritonavir as recommended by your doctor.

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and must be opened as follows:

-Push the plastic screw cap down while turning it counter clockwise.

-Remove the unscrewed cap.

If you take more PREZISTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take PREZISTA

If you notice within 12 hours, you must take the tablets immediately. Always take with cobicistat or ritonavir and food. If you notice after 12 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking PREZISTA without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to contact your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.

Other clinically relevant severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)

-diarrhoea.

Common side effects (may affect up to 1 in 10 people)

-vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence

-headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance

-difficulty breathing, cough, nosebleed, throat irritation

-inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching

-kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night

-urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails

-muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis

-slowing down of the thyroid gland function. This can be seen in a blood test.

-high blood pressure, flushing

-red or dry eyes

-fever, swelling of lower limbs due to fluids, malaise, irritability, pain

-symptoms of infection, herpes simplex

-erectile dysfunction, enlargement of breasts

-sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)

-a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]

-heart attack, slow heart beating, palpitations

-visual disturbance

-chills, feeling abnormal

-a feeling of confusion or disorientation, altered mood, restlessness

-fainting, epileptic fits, changes or loss of taste

-mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue

-running nose

-skin lesions, dry skin

-stiffness of muscles or joints, joint pain with or without inflammation

-changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

-muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PREZISTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.

PREZISTA does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What PREZISTA contains

-The active substance is darunavir. Each tablet contains 400 milligram of darunavir (as ethanolate).

-The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate. The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, sunset yellow FCF (E110).

What PREZISTA looks like and contents of the pack

Film-coated, light orange, oval shaped tablet, mentioning TMC on one side, 400MG on the other side. 60 tablets in a plastic bottle.

PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 600 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Janssen-Cilag NV

UAB "JOHNSON & JOHNSON"

Antwerpseweg 15-17

Geležinio Vilko g. 18A

B-2340 Beerse

LT-08104 Vilnius

Tel/Tél: +32 14 64 94 11

Tel: +370 5 278 68 88

България

Luxembourg/Luxemburg

„Джонсън & Джонсън България” ЕООД

Janssen-Cilag NV

ж.к. Младост 4

Antwerpseweg 15-17

Бизнес Парк София, сграда 4

B-2340 Beerse

София 1766

Belgique/Belgien

Тел.: +359 2 489 94 00

Tél/Tel: +32 14 64 94 11

Česká republika

Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov Tel: +420 227 012 227

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

España

Janssen-Cilag, S.A.

E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h

10010 Zagreb

Tel: +385 1 6610 700

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

România

Johnson & Johnson România SRL Str. Tipografilor nr. 11-15

Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA

Tel: +40 21 207 1800

Ireland

Slovenija

Janssen-Cilag Ltd.

Johnson & Johnson d.o.o.

50-100 Holmers Farm Way

Šmartinska cesta 53

High Wycombe

SI-1000 Ljubljana

Buckinghamshire HP12 4EG

Tel: +386 1 401 18 30

United Kingdom

 

Tel: +44 1 494 567 444

 

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

PREZISTA 600 mg film-coated tablets darunavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.What PREZISTA is and what it is used for

2.What you need to know before you take PREZISTA

3.How to take PREZISTA

4.Possible side effects

5.How to store PREZISTA

6.Contents of the pack and other information

1. What PREZISTA is and what it is used for

What is PREZISTA?

PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?

PREZISTA is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.

PREZISTA must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take PREZISTA

Do not take PREZISTA

-if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.

-if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.

Do not combine PREZISTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Cisapride

to treat some stomach conditions

Colchicine (if you have kidney and/or liver

to treat gout or familial Mediterranean fever

problems)

 

Lurasidone, pimozide, quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine,

to treat migraine and headaches

dihydroergotamine, ergometrine and

 

methylergonovine

 

Amiodarone, bepridil, dronedarone, quinidine,

to treat certain heart disorders e.g. abnormal

ranolazine and systemic lidocaine

heart beat

Lovastatin and simvastatin

to lower cholesterol levels

Rifampicin

to treat some infections such as tuberculosis

The combination product lopinavir/ritonavir

this anti-HIV medicine belongs to the same class

 

as PREZISTA

Elbasvir/grazoprevir

to treat hepatitis C infection

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary

 

circulation

Ticagrelor

to help stop the clumping of platelets in the

 

treatment of patients with a history of a heart

 

attack

Do not combine PREZISTA with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PREZISTA.

PREZISTA is not a cure for HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment

Make sure that you check the following points and tell your doctor if any of these apply to you.

-Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.

-Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.

-Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

-In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of

the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

-Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.

-Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

-Tell your doctor if you notice any musculoskeletal problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children

PREZISTA is not for use in children younger than 3 years of age or weighing less than 15 kilograms.

Other medicines and PREZISTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

-Phenobarbital, phenytoin (to prevent seizures)

-Dexamethasone (corticosteroid)

-Efavirenz (HIV infection)

-Telaprevir, boceprevir (hepatitis C infection)

-Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)

-Saquinavir (HIV infection).

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

-Apixaban, dabigatran etexilate, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

-Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

-Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle tissue disorder might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

-Clarithromycin (antibiotic)

-Ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

-Corticosteroids including bethametasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

-Buprenorphine/naloxone (medicines to treat opiate dependence)

-Salmeterol (medicine to treat asthma)

-Artemether/lumefantrine (a combination medicine to treat malaria)

-Dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)

-Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)

-Simeprevir (to treat hepatitis C infection).

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

-Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)

-Digoxin (to treat certain heart disorders)

-Clarithromycin (antibiotic)

-Ketoconazole, itraconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.

-Rifabutin (against bacterial infections)

-Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)

-Maraviroc (to treat HIV infection)

-Methadone (to treat opiate dependance)

-Carbamazepine (to prevent seizures or to treat certain types of nerve pain)

-Colchicine (to treat gout or familial Mediterranean fever)

-Bosentan (to treat high blood pressure in the pulmonary circulation)

-Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally, zoldipem (sedative agents)

-Risperidone, thioridazine (to treat psychiatric conditions).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

PREZISTA with food and drink

See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking PREZISTA.

PREZISTA tablets contain sunset yellow FCF (E110) which may cause allergic reactions.

3. How to take PREZISTA

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Even if you feel better, do not stop taking PREZISTA and ritonavir without talking to your doctor.

After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)

You will require a different dose of PREZISTA which cannot be administered with these 600 milligram tablets. Other strengths of PREZISTA are available.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)

The dose is either:

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily. OR

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily. PREZISTA 400 milligram and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.

Please discuss with your doctor which dose is right for you.

Instructions for adults

-Take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-In the morning, take one 600 milligram PREZISTA tablet together with 100 milligram ritonavir.

-In the evening, take one 600 milligram PREZISTA tablet together with 100 milligram ritonavir.

-Take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-Swallow the tablets with a drink such as water or milk.

-PREZISTA 75 milligram and 150 milligram tablets and 100 milligram per milliliter oral suspension have been developed for use in children, but can also be used in adults in some cases.

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right once daily dose based on the weight of the child (see table below). This dose must not exceed the recommended adult dose, which is 800 milligram PREZISTA together with 100 milligram ritonavir once a day.

The doctor will inform you on how much PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take.

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this)

The doctor will work out the right dose based on the weight of the child (see table below). The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligram PREZISTA together with

100 milligram of ritonavir two times per day or 800 milligram PREZISTA together with

100 milligram ritonavir once a day. The doctor will inform you on how many PREZISTA tablets and how much ritonavir (capsules, tablets or solution) the child must take. Tablets of lower strengths are available to construct the appropriate dosing regimen. PREZISTA oral suspension is also available.

Your doctor will determine whether PREZISTA tablets or oral suspension is right for the child.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram PREZISTA + 50 milligram ritonavir twice a day

between 30 and 40 kilograms

450 milligram PREZISTA + 60 milligram ritonavir twice a day

more than 40 kilograms*

600 milligram PREZISTA + 100 milligram ritonavir twice a day

*For children aged 12 or more and weighing at least 40 kilograms, your child’s doctor will determine if PREZISTA 800 milligram once daily dosing may be used. This cannot be administered with these 600 milligram tablets. Other strengths of PREZISTA are available.

Once daily dosing

 

Weight

One PREZISTA dose is

One ritonavira dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

a

ritonavir oral solution: 80 milligram per milliliter

 

 

 

Instructions for children

-The child must take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.

-The child must take the appropriate doses of PREZISTA and ritonavir two times per day or once a day. If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening. Your child’s doctor will determine the appropriate dosing regimen for your child.

-The child must take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important.

-The child must swallow the tablets with a drink such as water or milk.

-PREZISTA 75 milligram and 150 milligram tablets and 100 milligram per milliliter oral suspension have been developed for use in children weighing less than 40 kilograms, but can also be used in some cases.

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and must be opened as follows:

-Push the plastic screw cap down while turning it counter clockwise.

-Remove the unscrewed cap.

If you take more PREZISTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take PREZISTA

If you notice within 6 hours, you must take your missed dose immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking PREZISTA without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to contact your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.

Other clinically relevant severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)

-diarrhoea.

Common side effects (may affect up to 1 in 10 people)

-vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence

-headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance

-difficulty breathing, cough, nosebleed, throat irritation

-inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching

-kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night

-urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails

-muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis

-slowing down of the thyroid gland function. This can be seen in a blood test.

-high blood pressure, flushing

-red or dry eyes

-fever, swelling of lower limbs due to fluids, malaise, irritability, pain

-symptoms of infection, herpes simplex

-erectile dysfunction, enlargement of breasts

-sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)

-a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]

-heart attack, slow heart beating, palpitations

-visual disturbance

-chills, feeling abnormal

-a feeling of confusion or disorientation, altered mood, restlessness

-fainting, epileptic fits, changes or loss of taste

-mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue

-running nose

-skin lesions, dry skin

-stiffness of muscles or joints, joint pain with or without inflammation

-changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

-muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PREZISTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.

PREZISTA does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What PREZISTA contains

-The active substance is darunavir. Each tablet contains 600 milligram of darunavir (as ethanolate).

-The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate. The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, sunset yellow FCF (E110).

What PREZISTA looks like and contents of the pack

Film-coated, orange, oval shaped tablet, mentioning TMC on one side, 600MG on the other side. 60 tablets in a plastic bottle.

PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram,400 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél: +32 14 64 94 11

България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4 Бизнес Парк София, сграда 4 София 1766

Тел.: +359 2 489 94 00

Česká republika

Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov Tel: +420 227 012 227

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A

LT-08104 Vilnius

Tel: +370 5 278 68 88

Luxembourg/Luxemburg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgique/Belgien

Tél/Tel: +32 14 64 94 11

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300

España

Janssen-Cilag, S.A.

Paseo de las Doce Estrellas, 5-7 E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h

10010 Zagreb

Tel: +385 1 6610 700

Ireland

Janssen-Cilag Ltd.

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Tel: +44 1 494 567 444

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

România

Johnson & Johnson România SRL Str. Tipografilor nr. 11-15

Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA

Tel: +40 21 207 1800

Slovenija

Johnson & Johnson d.o.o. Šmartinska cesta 53 SI-1000 Ljubljana

Tel: +386 1 401 18 30

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

PREZISTA 800 mg film-coated tablets darunavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.What PREZISTA is and what it is used for

2.What you need to know before you take PREZISTA

3.How to take PREZISTA

4.Possible side effects

5.How to store PREZISTA

6.Contents of the pack and other information

1. What PREZISTA is and what it is used for

What is PREZISTA?

PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?

The PREZISTA 800 milligram tablet is used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and

-who have not used antiretroviral medicines before.

-in certain patients who have used antiretroviral medicines before (your doctor will determine this).

PREZISTA must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take PREZISTA

Do not take PREZISTA

-if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir.

-if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.

Do not combine PREZISTA with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine.

Medicine

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by mouth) midazolam

to help you sleep and/or relieve anxiety

Cisapride

to treat some stomach conditions

Colchicine (if you have kidney and/or liver

to treat gout or familial Mediterranean fever

problems)

 

Lurasidone, pimozide, quetiapine or sertindole

to treat psychiatric conditions

Ergot alkaloids like ergotamine,

to treat migraine and headaches

dihydroergotamine, ergometrine and

 

methylergonovine

 

Amiodarone, bepridil, dronedarone, quinidine,

to treat certain heart disorders e.g. abnormal

ranolazine and systemic lidocaine

heart beat

Lovastatin and simvastatin

to lower cholesterol levels

Rifampicin

to treat some infections such as tuberculosis

The combination product lopinavir/ritonavir

this anti-HIV medicine belongs to the same class

 

as PREZISTA

Elbasvir/grazoprevir

to treat hepatitis C infection

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary

 

circulation

Ticagrelor

to help stop the clumping of platelets in the

 

treatment of patients with a history of a heart

 

attack

Do not combine PREZISTA with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PREZISTA.

PREZISTA is not a cure for HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment

Make sure that you check the following points and tell your doctor if any of these apply to you.

-Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.

-Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.

-Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

-In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after

the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

-Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.

-Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).

-Tell your doctor if you notice any musculoskeletal problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Children and adolescents

The PREZISTA 800 milligram tablet is not for use in children younger than 3 years of age or weighing less than 40 kilograms.

Other medicines and PREZISTA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with cobicistat or ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

-Phenobarbital, phenytoin (to prevent seizures)

-Dexamethasone (corticosteroid)

-Efavirenz (HIV infection)

-Telaprevir, boceprevir (hepatitis C infection)

-Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)

-Saquinavir (HIV infection).

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.

-Apixaban, dabigatran etexilate, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.

-Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.

-Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle tissue disorder might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.

-Clarithromycin (antibiotic)

-Ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the therapeutic effect or side effects of these medicines might be increased. Your doctor might want to do some additional tests.

-Corticosteroids including bethametasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

-Buprenorphine/naloxone (medicines to treat opiate dependence)

-Salmeterol (medicine to treat asthma)

-Artemether/lumefantrine (a combination medicine to treat malaria)

-Dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)

-Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)

-Simeprevir (to treat hepatitis C infection).

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or side effects may be influenced when combined.

Tell your doctor if you take:

-Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)

-Digoxin (to treat certain heart disorders)

-Clarithromycin (antibiotic)

-Ketoconazole, itraconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.

-Rifabutin (against bacterial infections)

-Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)

-Maraviroc (to treat HIV infection)

-Methadone (to treat opiate dependance)

-Carbamazepine (to prevent seizures or to treat certain types of nerve pain)

-Colchicine (to treat gout or familial Mediterranean fever)

-Bosentan (to treat high blood pressure in the pulmonary circulation)

-Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally, zoldipem (sedative agents)

-Perphenazine, risperidone, thioridazine (to treat psychiatric conditions)

-Metformin (to treat type 2 diabetes).

This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.

PREZISTA with food and drink

See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines

Do not operate machines or drive if you feel dizzy after taking PREZISTA.

3. How to take PREZISTA

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor.

After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.

PREZISTA 800 milligram tablets are intended for once daily use only.

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)

The usual dose of PREZISTA is 800 milligram (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) once daily.

You must take PREZISTA every day and always in combination with 150 milligram of cobicistat or 100 milligram of ritonavir and with food. PREZISTA cannot work properly without cobicistat or ritonavir and food. You must eat a meal or a snack within 30 minutes prior to taking your PREZISTA and cobicistat or ritonavir. The type of food is not important. Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor.

Instructions for adults

-Take one 800 milligram tablet at the same time, once a day, every day.

-Take PREZISTA always together with 150 milligram of cobicistat or 100 milligram of ritonavir.

-Take PREZISTA with food.

-Swallow the tablet with a drink such as water or milk.

-Take your other HIV medicines used in combination with PREZISTA and cobicistat or ritonavir as recommended by your doctor.

-PREZISTA 100 milligram per milliliter oral suspension has been developed for use in children, but can also be used in adults in some cases.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)

The dose is either:

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 150 milligram cobicistat or

100 milligram ritonavir once daily. OR

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily.

Please discuss with your doctor which dose is right for you.

Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this)

-The usual dose of PREZISTA is 800 milligram (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily.

Dose for children 3 years of age and above, weighing more than 40 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this)

The dose is either:

-800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) together with 100 milligram ritonavir once daily. OR

-600 milligram PREZISTA (2 tablets containing 300 milligram of PREZISTA or 1 tablet containing 600 milligram of PREZISTA) together with 100 milligram ritonavir twice daily.

Please discuss with your doctor which dose is right for you.

Instructions for children 3 years of age and above, weighing more than 40 kilograms

-Take 800 milligram PREZISTA (2 tablets containing 400 milligram of PREZISTA or 1 tablet containing 800 milligram of PREZISTA) at the same time, once a day, every day.

-Take PREZISTA always together with 100 milligram of ritonavir.

-Take PREZISTA with food.

-Swallow the tablets with a drink such as water or milk.

-Take your other HIV medicines used in combination with PREZISTA and ritonavir as recommended by your doctor

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and must be opened as follows:

-Push the plastic screw cap down while turning it counter clockwise.

-Remove the unscrewed cap.

If you take more PREZISTA than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take PREZISTA

If you notice within 12 hours, you must take the tablets immediately. Always take with cobicistat or ritonavir and food. If you notice after 12 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking PREZISTA without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects.

Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to contact your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped.

Other clinically relevant severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)

-diarrhoea.

Common side effects (may affect up to 1 in 10 people)

-vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence

-headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance

-difficulty breathing, cough, nosebleed, throat irritation

-inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching

-kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night

-urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails

-muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis

-slowing down of the thyroid gland function. This can be seen in a blood test.

-high blood pressure, flushing

-red or dry eyes

-fever, swelling of lower limbs due to fluids, malaise, irritability, pain

-symptoms of infection, herpes simplex

-erectile dysfunction, enlargement of breasts

-sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)

-a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]

-heart attack, slow heart beating, palpitations

-visual disturbance

-chills, feeling abnormal

-a feeling of confusion or disorientation, altered mood, restlessness

-fainting, epileptic fits, changes or loss of taste

-mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue

-running nose

-skin lesions, dry skin

-stiffness of muscles or joints, joint pain with or without inflammation

-changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

-muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PREZISTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.

PREZISTA does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What PREZISTA contains

The active substance is darunavir. Each tablet contains 800 milligram of darunavir (as ethanolate). The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, hypromellose. The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172).

What PREZISTA looks like and contents of the pack

Film-coated, dark red, oval shaped tablet, mentioning T on one side, 800 on the other side. 30 tablets in a plastic bottle. The Prezista 800 milligram tablets are available in packs containing one bottle or three bottles per carton.

Not all pack sizes may be marketed.

PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 400 milligram and 600 milligram film-coated tablets and 100 milligram per milliliter oral suspension.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Janssen-Cilag NV

UAB "JOHNSON & JOHNSON"

Antwerpseweg 15-17

Geležinio Vilko g. 18A

B-2340 Beerse

LT-08104 Vilnius

Tel/Tél: +32 14 64 94 11

Tel: +370 5 278 68 88

България

Luxembourg/Luxemburg

„Джонсън & Джонсън България” ЕООД

Janssen-Cilag NV

ж.к. Младост 4

Antwerpseweg 15-17

Бизнес Парк София, сграда 4

B-2340 Beerse

София 1766

Belgique/Belgien

Тел.: +359 2 489 94 00

Tél/Tel: +32 14 64 94 11

Česká republika

Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov Tel: +420 227 012 227

Danmark

Janssen-Cilag A/S

Bregnerødvej 133

DK-3460 Birkerød

Tlf: +45 45 94 82 82

Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

D-41470 Neuss

Tel: +49 2137 955-955

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn

Tel: +372 617 7410

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

España

Janssen-Cilag, S.A.

E-28042 Madrid

Tel: +34 91 722 81 00

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h

10010 Zagreb

Tel: +385 1 6610 700

Magyarország

Janssen-Cilag Kft.

Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75

NL-4837 DS Breda

Tel: +31 76 711 1111

Norge

Janssen-Cilag AS

Postboks 144

NO-1325-Lysaker

Tlf: +47 24 12 65 00

Österreich

Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa

Tel.: +48 22 237 60 00

Portugal

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835

România

Johnson & Johnson România SRL Str. Tipografilor nr. 11-15

Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA

Tel: +40 21 207 1800

Ireland

Slovenija

Janssen-Cilag Ltd.

Johnson & Johnson d.o.o.

50-100 Holmers Farm Way

Šmartinska cesta 53

High Wycombe

SI-1000 Ljubljana

Buckinghamshire HP12 4EG

Tel: +386 1 401 18 30

United Kingdom

 

Tel: +44 1 494 567 444

 

Ísland

Slovenská republika

Janssen-Cilag AB

Johnson & Johnson s.r.o.

c/o Vistor hf.

CBC III, Karadžičova 12

Hörgatúni 2

SK-821 08 Bratislava

IS-210 Garðabær

Tel: +421 232 408 400

Sími: +354 535 7000

 

Italia

Suomi/Finland

Janssen-Cilag SpA

Janssen-Cilag Oy

Via M.Buonarroti, 23

Vaisalantie/Vaisalavägen 2

I-20093 Cologno Monzese MI

FI-02130 Espoo/Esbo

Tel: +39 02 2510 1

Puh/Tel: +358 207 531 300

Κύπρος

Sverige

Βαρνάβας Χατζηπαναγής Λτδ,

Janssen-Cilag AB

Λεωφόρος Γιάννου Κρανιδιώτη 226

Box 4042

Λατσιά

SE-16904 Solna

CY-2234 Λευκωσία

Tel: +46 8 626 50 00

Τηλ: +357 22 207 700

 

Latvija

United Kingdom

UAB "JOHNSON & JOHNSON" filiāle Latvijā

Janssen-Cilag Ltd.

Mūkusalas iela 101

50-100 Holmers Farm Way

Rīga, LV-1004

High Wycombe

Tel: +371 678 93561

Buckinghamshire HP12 4EG - UK

 

Tel: +44 1 494 567 444

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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