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Darunavir Mylan (darunavir) – Package leaflet - J05AE10

Updated on site: 06-Oct-2017

Medication nameDarunavir Mylan
ATC CodeJ05AE10
Substancedarunavir
ManufacturerMylan S.A.S.

Package leaflet: Information for the user

Darunavir Mylan 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. See section 4.

What is in this leaflet

1.What Darunavir Mylan is and what it is used for

2.What you need to know before you take Darunavir Mylan

3.How to take Darunavir Mylan

4.Possible side effects

5.How to store Darunavir Mylan

6.Contents of the pack and other information

1.What Darunavir Mylan is and what it is used for

What is Darunavir Mylan?

Darunavir Mylan contains the active substance darunavir. Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir 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?

Darunavir 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.

Darunavir 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 Darunavir Mylan

Do not take Darunavir Mylan:

-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 Darunavir Mylan 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 heart

ranolazine and systemic lidocaine

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

 

darunavir

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 darunavir with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Darunavir Mylan.

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

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

Darunavir 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 Darunavir Mylan.

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 darunavir.

-Tell your doctor if you have diabetes. Darunavir 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. Darunavir 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

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

Other medicines and Darunavir Mylan

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 darunavir. These are mentioned above under the heading ‘Do not combine Darunavir Mylan with any of the following medicines:’

In most cases, darunavir 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)]. Darunavir 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 darunavir 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 darunavir. 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. Darunavir 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 darunavir’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.

Darunavir Mylan with food and drink

See section 3 ‘How to take Darunavir Mylan’.

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 darunavir 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 darunavir.

3.How to take Darunavir Mylan

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 Darunavir Mylan 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 darunavir together with 100 milligram ritonavir once a day.

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

Weight

One darunavir 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 darunavir together with

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

The doctor will inform you on how many Darunavir Mylan 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.

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram darunavir + 50 milligram ritonavir

 

twice a day

between 30 and 40 kilograms

450 milligram darunavir + 60 milligram ritonavir

 

twice a day

more than 40 kilograms*

600 milligram darunavir + 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 Darunavir Mylan

800 milligram once daily dosing may be used. This cannot be administered with these 75 milligram tablets. Other strengths of Darunavir Mylan are available.

Once daily dosing

Weight

One darunavir 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

Instructions for children

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

-The child must take the appropriate doses of darunavir and ritonavir two times per day or once a day. If prescribed darunavir 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 darunavir with food. Darunavir 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 darunavir which cannot be administered with these 75 milligram tablets. Other strengths of Darunavir Mylan are available.

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

The dose is either:

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

OR

-800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily. Darunavir Mylan 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 darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

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

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

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

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

-Darunavir Mylan 75 milligram and 150 milligram tablets have been developed for use in children, but can also be used in adults in some cases.

If you take more Darunavir Mylan than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Mylan

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 Darunavir Mylan without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking darunavir. 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 darunavir. 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 darunavir must be stopped.

Other clinically relevant severe side effects were 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 sensitivity, 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 darunavir. 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 Darunavir Mylan

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, blister and on the bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

For bottles: Once opened, use within 100 days.

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 Darunavir Mylan contains

-The active substance is darunavir. Each tablet contains 75 milligrams of darunavir.

-The other ingredients are colloidal anhydrous silica, cellulose microcrystalline, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide, macrogol and talc.

What Darunavir Mylan looks like and contents of the pack

Darunavir Mylan 75 mg film-coated tablets are white to off-white, oval shaped with two curved sides, marked with M on one side and DV1 on the other side.

Darunavir Mylan 75 mg film-coated tablets are available in blister packs containing 480 tablets and in plastic bottles containing 480 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allee des Parcs

69 800 Saint Priest France

Manufacturer

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

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

België/Belgique/Belgien

Lietuva

Mylan bvba/sprl

BGP Products UAB

Tél/Tel: + 32 02 658 61 00

Tel: +370 5 205 1288

България

Luxembourg/Luxemburg

Майлан ЕООД

Mylan bvba/sprl

Тел: +359 2 44 55 400

Tel: + 32 02 658 61 00

 

(Belgique/Belgien)

Česká republika

Magyarország

Mylan Pharmaceuticals.s.r.o.

Mylan EPD Kft

Tel: + 420 222 004 400

Tel: + 36 1 465 2100

Danmark

Malta

Mylan AB

V.J. Salomone Pharma Ltd

Tlf: + 46 855 522 750

Tel: + 356 21 22 01 74

(Sverige)

 

Deutschland

Nederland

Mylan dura GmbH

Mylan BV

Tel: + 49-(0) 6151 9512 0

Tel: + 31 33 299 7080

Eesti

Norge

BGP Products Switzerland GmbH Eesti

Mylan AB

filiaal

Tel: + 46 855 522 750

Tel: + 372 6363 052

(Sverige)

Ελλάδα

Österreich

Generics Pharma Hellas ΕΠΕ

Arcana Arzneimittel GmbH

Τηλ: +30 210 993 6410

Tel: +43 1 416 2418

España

Polska

Mylan Pharmaceuticals, S.L

Mylan Sp. z.o.o.

Tel: + 34 900 102 712

Tel: + 48 22 546 64 00

France

Portugal

Mylan S.A.S

Mylan, Lda.

Tel: +33 4 37 25 75 00

Tel: + 351 21 412 72 56

Hrvatska

România

Mylan Hrvatska d.o.o.

A&G Med Trading SRL

Tel: +385 1 23 50 599

Tel: + 4021 332 49 91

Ireland

Slovenija

Generics [UK] Ltd.

GSP Proizvodi d.o.o.

Tel: + 44 1707 853000

Tel: + 386 1 236 31 85

(United Kingdom)

 

Ísland

Slovenská republika

Mylan AB

Mylan s.r.o.

Tel: + 46 855 522 750

Tel: +421 2 326 04 910 / +421 917 206 274

(Svíþjóð)

 

Italia

Suomi/Finland

Mylan S.p.A

Mylan OY

Tel: + 39 02 612 46921

Puh/Tel: + 358 9-46 60 03

Κύπρος

Sverige

Pharmaceutical Trading Co. Ltd.

Mylan AB

Τηλ: + 357 99403969

Tel: + 46 855 522 750

Latvija

United Kingdom

BGP Products SIA

Generics [UK] Ltd

Tel: +371 676 055 80

Tel: +44 1707 853000

Other sources of information

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

Darunavir Mylan 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. See section 4.

What is in this leaflet

1.What Darunavir Mylan is and what it is used for

2.What you need to know before you take Darunavir Mylan

3.How to take Darunavir Mylan

4.Possible side effects

5.How to store Darunavir Mylan

6.Contents of the pack and other information

1. What Darunavir Mylan is and what it is used for

What is Darunavir Mylan?

Darunavir Mylan contains the active substance darunavir. Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir 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?

Darunavir 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.

Darunavir 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 Darunavir Mylan

Do not take Darunavir Mylan:

-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 Darunavir Mylan 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, quetiapineor 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 heart

ranolazine and systemic lidocaine

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

 

darunavir

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 darunavir with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Darunavir Mylan.

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

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

Darunavir 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 Darunavir Mylan.

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 darunavir.

-Tell your doctor if you have diabetes. Darunavir 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. Darunavir 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

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

Other medicines and Darunavir Mylan

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 darunavir. These are mentioned above under the heading ‘Do not combine Darunavir Mylan with any of the following medicines:’

In most cases, darunavir 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)]. Darunavir 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 darunavir 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 darunavir. 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. Darunavir 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 darunavir’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.

Darunavir Mylan with food and drink

See section 3 ‘How to take Darunavir Mylan.

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 darunavir 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 darunavir.

3. How to take Darunavir Mylan

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 Darunavir Mylan 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 darunavir together with 100 milligram ritonavir once a day.

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

Weight

One darunavir 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 darunavir together with

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

The doctor will inform you on how many Darunavir Mylan 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.

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram darunavir + 50 milligram ritonavir

 

twice a day

between 30 and 40 kilograms

450 milligram darunavir + 60 milligram ritonavir

 

twice a day

more than 40 kilograms*

600 milligram darunavir + 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 Darunavir Mylan

800 milligram once daily dosing may be used. This cannot be administered with these 150 milligram tablets. Other strengths of Darunavir Mylan are available.

Once daily dosing

 

One darunavir dose is

One ritonavira dose is

Weight

 

 

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 darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

-The child must take the appropriate doses of darunavir and ritonavir two times per day or once a day. If prescribed darunavir 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 darunavir with food. Darunavir 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 darunavir which cannot be administered with these 150 milligram tablets. Other strengths of Darunavir Mylan are available.

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

The dose is either:

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

OR

-800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily. Darunavir Mylan 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 darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

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

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

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

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

-Darunavir Mylan 75 milligram and 150 milligram tablets have been developed for use in children, but can also be used in adults in some cases.

If you take more Darunavir Mylan than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Mylan

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 Darunavir Mylan without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking darunavir. 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 darunavir. 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 darunavir must be stopped.

Other clinically relevant severe side effects were 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 sensitivity, 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 darunavir. 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 Darunavir Mylan

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, blister and on the bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

For bottles: Once opened, use within 100 days.

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 Darunavir Mylan contains

-The active substance is darunavir. Each tablet contains 150 milligram of darunavir.

-The other ingredients are colloidal anhydrous silica, cellulose microcrystalline, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide, macrogol and talc.

What Darunavir Mylan looks like and contents of the pack

Darunavir Mylan 150 mg film-coated tablets are white to off-white, capsule shaped, with two curved sides, marked with M on one side and DV2 on the other side.

Darunavir Mylan 150 mg film-coated tablets are available in blister packs containing 240 tablets and in plastic bottles containing 60 and 240 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allee des Parcs

69 800 Saint Priest France

Manufacturers

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

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

België/Belgique/Belgien

Lietuva

Mylan bvba/sprl

BGP Products UAB

Tél/Tel: + 32 02 658 61 00

Tel: +370 5 205 1288

България

Luxembourg/Luxemburg

Майлан ЕООД

Mylan bvba/sprl

Тел: +359 2 44 55 400

Tel: + 32 02 658 61 00

 

(Belgique/Belgien)

Česká republika

Magyarország

Mylan Pharmaceuticals.s.r.o.

Mylan EPD Kft

Tel: + 420 222 004 400

Tel: + 36 1 465 2100

Danmark

Malta

Mylan AB

V.J. Salomone Pharma Ltd

Tlf: + 46 855 522 750

Tel: + 356 21 22 01 74

(Sverige)

 

Deutschland

Nederland

Mylan dura GmbH

Mylan BV

Tel: + 49-(0) 6151 9512 0

Tel: + 31 33 299 7080

Eesti

Norge

BGP Products Switzerland GmbH Eesti

Mylan AB

filiaal

Tel: + 46 855 522 750

Tel: + 372 6363 052

(Sverige)

Ελλάδα

Österreich

Generics Pharma Hellas ΕΠΕ

Arcana Arzneimittel GmbH

Τηλ: +30 210 993 6410

Tel: +43 1 416 2418

España

Polska

Mylan Pharmaceuticals, S.L

Mylan Sp. z.o.o.

Tel: + 34 900 102 712

Tel: + 48 22 546 64 00

France

Portugal

Mylan S.A.S

Mylan, Lda.

Tel: +33 4 37 25 75 00

Tel: + 351 21 412 72 56

Hrvatska

România

Mylan Hrvatska d.o.o.

A&G Med Trading SRL

Tel: +385 1 23 50 599

Tel: + 4021 332 49 91

Ireland

Slovenija

Generics [UK] Ltd.

GSP Proizvodi d.o.o.

Tel: + 44 1707 853000

Tel: + 386 1 236 31 85

(United Kingdom)

 

Ísland

Slovenská republika

Mylan AB

Mylan s.r.o.

Tel: + 46 855 522 750

Tel: +421 2 326 04 910 / +421 917 206 274

(Svíþjóð)

 

Italia

Suomi/Finland

Mylan S.p.A

Mylan OY

Tel: + 39 02 612 46921

Puh/Tel: + 358 9-46 60 03

Κύπρος

Sverige

Pharmaceutical Trading Co. Ltd.

Mylan AB

Τηλ: + 357 99403969

Tel: + 46 855 522 750

Latvija

United Kingdom

BGP Products SIA

Generics [UK] Ltd

Tel: +371 676 055 80

Tel: +44 1707 853000

Other sources of information

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

Darunavir Mylan 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. See section 4.

What is in this leaflet

1.What Darunavir Mylan is and what it is used for

2.What you need to know before you take Darunavir Mylan

3.How to take Darunavir Mylan

4.Possible side effects

5.How to store Darunavir Mylan

6.Contents of the pack and other information

1. What Darunavir Mylan is and what it is used for

What is Darunavir Mylan?

Darunavir Mylan contains the active substance darunavir. Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir 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?

Darunavir 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.

Darunavir 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 Darunavir Mylan

Do not take Darunavir Mylan:

-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 Darunavir Mylan 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 heart

ranolazine and systemic lidocaine

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

 

Darunavir Mylan

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 darunavir with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Darunavir Mylan.

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

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

Darunavir 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 Darunavir Mylan.

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 darunavir.

-Tell your doctor if you have diabetes. Darunavir 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. Darunavir 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

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

Other medicines and Darunavir Mylan

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 darunavir. These are mentioned above under the heading ‘Do not combine Darunavir Mylan with any of the following medicines:’

In most cases, darunavir 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)]. Darunavir 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 darunavir 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 darunavir. 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. Darunavir 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 darunavir’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.

Darunavir Mylan with food and drink

See section 3 ‘How to take Darunavir Mylan’.

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 Darunavir Mylan 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 Darunavir Mylan.

3. How to take Darunavir Mylan

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 Darunavir Mylan 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 darunavir which cannot be administered with these 300 milligram tablets. Other strengths of Darunavir Mylan are available.

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

The dose is either:

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

OR

-800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily. Darunavir Mylan 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 darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

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

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

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

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

-Darunavir 75 milligram and 150 milligram tablets 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 darunavir together with 100 milligram ritonavir once a day.

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

Weight

One darunavir 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 darunavir together with

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

The doctor will inform you on how many Darunavir Mylan 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.

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram darunavir + 50 milligram ritonavir

 

twice a day

between 30 and 40 kilograms

450 milligram darunavir + 60 milligram ritonavir

 

twice a day

more than 40 kilograms*

600 milligram darunavir + 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 Darunavir Mylan

800 milligram once daily dosing may be used. This cannot be administered with these 300 milligram tablets. Other strengths of Darunavir Mylan are available.

Once daily dosing

Weight

One darunavir 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 darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

-The child must take the appropriate doses of darunavir and ritonavir two times per day or once a day. If prescribed darunavir 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 darunavir with food. Darunavir 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.

If you take more Darunavir Mylan than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Mylan

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 Darunavir Mylan without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking Darunavir Mylan. 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 incease 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 darunavir. 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 darunavir must be stopped.

Other clinically relevant severe side effects were 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 sensitivity, 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 darunavir. 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 Darunavir Mylan

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, blister and on the bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

For bottles: Once opened, use within 100 days.

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 Darunavir Mylan contains

-The active substance is darunavir. Each tablet contains 300 milligram of darunavir.

-The other ingredients are colloidal anhydrous silica, cellulose microcrystalline, crospovidone (Type A), sodium starch glycolate, hypromellose, magnesium stearate. The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide, macrogol and talc.

What Darunavir Mylan looks like and contents of the pack

Darunavir Mylan 300 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV3 on the other side.

Darunavir Mylan 300 mg film-coated tablets are available in blister packs containing 30, 60 and 120 tablets and in plastic bottles containing 30 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allee des Parcs

69 800 Saint Priest France

Manufacturer

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

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

België/Belgique/Belgien

Lietuva

Mylan bvba/sprl

BGP Products UAB

Tél/Tel: + 32 02 658 61 00

Tel: +370 5 205 1288

България

Luxembourg/Luxemburg

Майлан ЕООД

Mylan bvba/sprl

Тел: +359 2 44 55 400

Tel: + 32 02 658 61 00

 

(Belgique/Belgien)

Česká republika

Magyarország

Mylan Pharmaceuticals.s.r.o.

Mylan EPD Kft

Tel: + 420 222 004 400

Tel: + 36 1 465 2100

Danmark

Malta

Mylan AB

V.J. Salomone Pharma Ltd

Tlf: + 46 855 522 750

Tel: + 356 21 22 01 74

(Sverige)

 

Deutschland

Nederland

Mylan dura GmbH

Mylan BV

Tel: + 49-(0) 6151 9512 0

Tel: + 31 33 299 7080

Eesti

Norge

BGP Products Switzerland GmbH Eesti

Mylan AB

filiaal

Tel: + 46 855 522 750

Tel: + 372 6363 052

(Sverige)

Ελλάδα

Österreich

Generics Pharma Hellas ΕΠΕ

Arcana Arzneimittel GmbH

Τηλ: +30 210 993 6410

Tel: +43 1 416 2418

España

Polska

Mylan Pharmaceuticals, S.L

Mylan Sp. z.o.o.

Tel: + 34 900 102 712

Tel: + 48 22 546 64 00

France

Portugal

Mylan S.A.S

Mylan, Lda.

Tel: +33 4 37 25 75 00

Tel: + 351 21 412 72 56

Hrvatska

România

Mylan Hrvatska d.o.o.

A&G Med Trading SRL

Tel: +385 1 23 50 599

Tel: + 4021 332 49 91

Ireland

Slovenija

Generics [UK] Ltd.

GSP Proizvodi d.o.o.

Tel: + 44 1707 853000

Tel: + 386 1 236 31 85

(United Kingdom)

 

Ísland

Slovenská republika

Mylan AB

Mylan s.r.o.

Tel: + 46 855 522 750

Tel: +421 2 326 04 910 / +421 917 206 274

(Svíþjóð)

 

Italia

Suomi/Finland

Mylan S.p.A

Mylan OY

Tel: + 39 02 612 46921

Puh/Tel: + 358 9-46 60 03

Κύπρος

Sverige

Pharmaceutical Trading Co. Ltd.

Mylan AB

Τηλ: + 357 99403969

Tel: + 46 855 522 750

Latvija*

United Kingdom

BGP Products SIA

Generics [UK] Ltd

Tel: +371 676 055 80

Tel: +44 1707 853000

Other sources of information

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

Darunavir Mylan 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. See section 4.

What is in this leaflet

1.What Darunavir Mylan is and what it is used for

2.What you need to know before you take Darunavir Mylan

3.How to take Darunavir Mylan

4.Possible side effects

5.How to store Darunavir Mylan

6.Contents of the pack and other information

1. What Darunavir Mylan is and what it is used for

What is Darunavir Mylan?

Darunavir Mylan contains the active substance darunavir. Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir 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?

Darunavir 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).

Darunavir 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 Darunavir Mylan

Do not take Darunavir Mylan:

-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 Darunavir Mylan 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 heart

ranolazine and systemic lidocaine

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

 

darunavir

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 darunavir with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Darunavir Mylan.

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

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

Darunavir 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 Darunavir Mylan.

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 darunavir.

-Tell your doctor if you have diabetes. Darunavir 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. Darunavir 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

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

Other medicines and Darunavir Mylan

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 darunavir. These are mentioned above under the heading ‘Do not combine Darunavir Mylan with any of the following medicines:’

In most cases, darunavir 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)]. Darunavir 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 darunavir 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 darunavir. 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. Darunavir 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 darunavir’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.

Darunavir Mylan with food and drink

See section 3 ‘How to take Darunavir Mylan.

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 darunavir 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 darunavir.

3. How to take Darunavir Mylan

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 darunavir 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.

Darunavir 400 mg tablets are only to be used to construct the once daily 800 mg regimen.

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

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

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

-Take darunavir with food.

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

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

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

The dose is either:

-800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 150 milligram cobicistat or 100 milligram ritonavir once daily.

OR

-600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) 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 darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) 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 darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.

OR

-600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) 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 darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) at the same time, once a day, every day.

-Take darunavir always together with 100 milligram of ritonavir.

-Take darunavir with food.

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

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

If you take more Darunavir Mylan than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Mylan

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 Darunavir Mylan without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking Darunavir Mylan. 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 darunavir. 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 darunavir must be stopped.

Other clinically relevant severe side effects were 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) 293

-chest pain, changes in electrocardiogram, rapid heart beating

-decreased or abnormal skin sensitivity, 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 darunavir. 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 Darunavir Mylan

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, blister and on the bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

For bottles: Once opened, use within 100 days.

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 Darunavir Mylan contains

-The active substance is darunavir. Each tablet contains 400 milligrams of darunavir.

-The other ingredients are colloidal anhydrous silica, cellulose microcrystalline, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide, macrogol and talc.

What Darunavir Mylan looks like and contents of the pack

Darunavir Mylan 400 mg film-coated tablets are white to off-white, oval shaped with two curved sides, marked with M on one side and DV4 on the other side.

Darunavir Mylan 400 mg film-coated tablets are available blister packs containing 30 and 60 tablets and in the HDPE bottles of 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allee des Parcs

69 800 Saint Priest France

Manufacturer

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

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

België/Belgique/Belgien

Lietuva

Mylan bvba/sprl

BGP Products UAB

Tél/Tel: + 32 02 658 61 00

Tel: +370 5 205 1288

България

Luxembourg/Luxemburg

Майлан ЕООД

Mylan bvba/sprl

Тел: +359 2 44 55 400

Tel: + 32 02 658 61 00

 

(Belgique/Belgien)

Česká republika

Magyarország

Mylan Pharmaceuticals.s.r.o.

Mylan EPD Kft

Tel: + 420 222 004 400

Tel: + 36 1 465 2100

 

Danmark

Malta

Mylan AB

V.J. Salomone Pharma Ltd

Tlf: + 46 855 522 750

Tel: + 356 21 22 01 74

(Sverige)

 

Deutschland

Nederland

Mylan dura GmbH

Mylan BV

Tel: + 49-(0) 6151 9512 0

Tel: + 31 33 299 7080

Eesti

Norge

BGP Products Switzerland GmbH Eesti

Mylan AB

filiaal

Tel: + 46 855 522 750

Tel: + 372 6363 052

(Sverige)

Ελλάδα

Österreich

Generics Pharma Hellas ΕΠΕ

Arcana Arzneimittel GmbH

Τηλ: +30 210 993 6410

Tel: +43 1 416 2418

España

Polska

Mylan Pharmaceuticals, S.L

Mylan Sp. z.o.o.

Tel: + 34 900 102 712

Tel: + 48 22 546 64 00

France

Portugal

Mylan S.A.S

Mylan, Lda.

Tel: +33 4 37 25 75 00

Tel: + 351 21 412 72 56

Hrvatska

România

Mylan Hrvatska d.o.o.

A&G Med Trading SRL

Tel: +385 1 23 50 599

Tel: + 4021 332 49 91

Ireland

Slovenija

Generics [UK] Ltd.

GSP Proizvodi d.o.o.

Tel: + 44 1707 853000

Tel: + 386 1 236 31 85

(United Kingdom)

 

Ísland

Slovenská republika

Mylan AB

Mylan s.r.o.

Tel: + 46 855 522 750

Tel: +421 2 326 04 910 / +421 917 206 274

(Svíþjóð)

 

Italia

Suomi/Finland

Mylan S.p.A

Mylan OY

Tel: + 39 02 612 46921

Puh/Tel: + 358 9-46 60 03

Κύπρος

Sverige

Pharmaceutical Trading Co. Ltd.

Mylan AB

Τηλ: + 357 99403969

Tel: + 46 855 522 750

Latvija

United Kingdom

BGP Products SIA

Generics [UK] Ltd

Tel: +371 676 055 80

Tel: +44 1707 853000

Other sources of information

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

Darunavir Mylan 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. See section 4.

What is in this leaflet

1.What Darunavir Mylan is and what it is used for

2.What you need to know before you take Darunavir Mylan

3.How to take Darunavir Mylan

4.Possible side effects

5.How to store Darunavir Mylan

6.Contents of the pack and other information

1. What Darunavir Mylan is and what it is used for

What is Darunavir Mylan?

Darunavir Mylan contains the active substance darunavir. Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir 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?

Darunavir 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. Darunavir 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 Darunavir Mylan

Do not take Darunavir Mylan:

-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 Darunavir Mylan 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, quetiapineor 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 heart

ranolazine and systemic lidocaine

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

 

Darunavir Mylan

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 darunavir with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Darunavir Mylan.

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

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

Darunavir 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 Darunavir Mylan.

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 darunavir.

-Tell your doctor if you have diabetes. Darunavir 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. Darunavir 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

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

Other medicines and Darunavir Mylan

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 darunavir. These are mentioned above under the heading ‘Do not combine Darunavir Mylan with any of the following medicines:’

In most cases, darunavir 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)]. Darunavir 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 darunavir 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 darunavir. 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. Darunavir 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 darunavir’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.

Darunavir Mylan with food and drink

See section 3 ‘How to take Darunavir Mylan.

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 Darunavir Mylan 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 Darunavir Mylan.

3. How to take Darunavir Mylan

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 Darunavir Mylan 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 darunavir which cannot be administered with these 600 milligram tablets. Other strengths of Darunavir Mylan are available.

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

The dose is either:

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

OR

-800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily. Darunavir Mylan 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 darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

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

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

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

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

-Darunavir Mylan 75 milligram and 150 milligram tablets 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 darunavir together with 100 milligram ritonavir once a day.

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

Weight

One darunavir 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 darunavir together with

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

The doctor will inform you on how many Darunavir Mylan 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.

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Twice daily dosing

Weight

One dose is

between 15 and 30 kilograms

375 milligram darunavir + 50 milligram ritonavir

 

twice a day

between 30 and 40 kilograms

450 milligram darunavir + 60 milligram ritonavir

 

twice a day

more than 40 kilograms*

600 milligram darunavir + 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 Darunavir Mylan

800 milligram once daily dosing may be used. This cannot be administered with these 600 milligram tablets. Other strengths of Darunavir Mylan are available.

Once daily dosing

Weight

One darunavir 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 darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

-The child must take the appropriate doses of darunavir and ritonavir two times per day or once a day. If prescribed darunavir 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 darunavir with food. Darunavir 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.

-Darunavir Mylan 75 mg and 150 mg tablets have been developed for use in children weighing less than 40 kilograms, but can also be used in adults in some cases.

If you take more Darunavir Mylan than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Mylan

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 Darunavir Mylan without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking Darunavir Mylan. 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 darunavir. 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 darunavir must be stopped.

Other clinically relevant severe side effects were 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 sensitivity, 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 darunavir. 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 Darunavir Mylan

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, blister and on the bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

For bottles: Once opened, use within 100 days.

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 Darunavir Mylan contains

-The active substance is darunavir. Each tablet contains 600 milligram of darunavir.

-The other ingredients are colloidal anhydrous silica, cellulose microcrystalline, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide, macrogol and talc.

What Darunavir Mylan looks like and contents of the pack

Darunavir Mylan 600 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV5 on the other side.

Darunavir Mylan 600 mg film-coated tablets are available in blister packs containing 30 and 60 tablets and in plastic bottles containing 30, 60 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allee des Parcs

69 800 Saint Priest France

Manufacturers

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

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

België/Belgique/Belgien

Lietuva

Mylan bvba/sprl

BGP Products UAB

Tél/Tel: + 32 02 658 61 00

Tel: +370 5 205 1288

България

Luxembourg/Luxemburg

Майлан ЕООД

Mylan bvba/sprl

Тел: +359 2 44 55 400

Tel: + 32 02 658 61 00

 

(Belgique/Belgien)

Česká republika

Magyarország

Mylan Pharmaceuticals.s.r.o.

Mylan EPD Kft

Tel: + 420 222 004 400

Tel: + 36 1 465 2100

Danmark

Malta

Mylan AB

V.J. Salomone Pharma Ltd

Tlf: + 46 855 522 750

Tel: + 356 21 22 01 74

(Sverige)

 

Deutschland

Nederland

Mylan dura GmbH

Mylan BV

Tel: + 49-(0) 6151 9512 0

Tel: + 31 33 299 7080

Eesti

Norge

BGP Products Switzerland GmbH Eesti

Mylan AB

filiaal

Tel: + 46 855 522 750

Tel: + 372 6363 052

(Sverige)

Ελλάδα

Österreich

Generics Pharma Hellas ΕΠΕ

Arcana Arzneimittel GmbH

Τηλ: +30 210 993 6410

Tel: +43 1 416 2418

España

Polska

Mylan Pharmaceuticals, S.L

Mylan Sp. z.o.o.

Tel: + 34 900 102 712

Tel: + 48 22 546 64 00

 

France

Portugal

Mylan S.A.S

Mylan, Lda.

Tel: +33 4 37 25 75 00

Tel: + 351 21 412 72 56

Hrvatska

România

Mylan Hrvatska d.o.o.

A&G Med Trading SRL

Tel: +385 1 23 50 599

Tel: + 4021 332 49 91

Ireland

Slovenija

Generics [UK] Ltd.

GSP Proizvodi d.o.o.

Tel: + 44 1707 853000

Tel: + 386 1 236 31 85

(United Kingdom)

 

Ísland

Slovenská republika

Mylan AB

Mylan s.r.o.

Tel: + 46 855 522 750

Tel: +421 2 326 04 910 / +421 917 206 274

(Svíþjóð)

 

Italia

Suomi/Finland

Mylan S.p.A

Mylan OY

Tel: + 39 02 612 46921

Puh/Tel: + 358 9-46 60 03

Κύπρος

Sverige

Pharmaceutical Trading Co. Ltd.

Mylan AB

Τηλ: + 357 99403969

Tel: + 46 855 522 750

Latvija

United Kingdom

BGP Products SIA

Generics [UK] Ltd

Tel: +371 676 055 80

Tel: +44 1707 853000

 

Other sources of information

 

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

Darunavir Mylan 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. See section 4.

What is in this leaflet

1.What Darunavir Mylan is and what it is used for

2.What you need to know before you take Darunavir Mylan

3.How to take Darunavir Mylan

4.Possible side effects

5.How to store Darunavir Mylan

6.Contents of the pack and other information

1. What Darunavir Mylan is and what it is used for

What is Darunavir Mylan?

Darunavir Mylan contains the active substance darunavir. Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir 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?

Darunavir 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).

Darunavir 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 Darunavir Mylan

Do not take Darunavir Mylan:

-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 Darunavir Mylan with any of the following medicines

If you are taking any of these, ask your doctor about switching to another medicine. 308

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 heart

ranolazine and systemic lidocaine

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

 

Darunavir Mylan

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 darunavir with products that contain St John’s wort (Hypericum perforatum).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Darunavir Mylan.

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

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

Darunavir 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 Darunavir Mylan.

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 darunavir.

-Tell your doctor if you have diabetes. Darunavir 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. Darunavir 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

Darunavir Mylan 800 mg tablets is not for use in children younger than 3 years of age or weighing less than 40 kilograms.

Other medicines and Darunavir Mylan

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 darunavir. These are mentioned above under the heading ‘Do not combine Darunavir Mylan with any of the following medicines:’

In most cases, darunavir 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)]. Darunavir 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 darunavir 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 darunavir. 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. Darunavir 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 darunavir’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.

Darunavir Mylan with food and drink

See section 3 ‘How to take Darunavir Mylan.

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 darunavir 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 darunavir.

3. How to take Darunavir Mylan

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 darunavir 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.

Darunavir Mylan 800 mg 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 darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) once daily.

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

-Take darunavir with food.

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

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

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

The dose is either:

-800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 150 milligram cobicistat or 100 milligram ritonavir once daily.

OR

-600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) 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 darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) 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 darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.

OR

-600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) 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 darunavir (2 tablets containing 400 milligram of Darunavir Mylan or 1 tablet containing 800 milligram of Darunavir Mylan) at the same time, once a day, every day.

-Take darunavir always together with 100 milligram of ritonavir.

-Take darunavir with food.

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

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

If you take more Darunavir Mylan than you should

Contact your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Mylan

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 Darunavir Mylan without talking to your doctor first

HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking Darunavir Mylan. 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 darunavir. 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 darunavir must be stopped.

Other clinically relevant severe side effects were 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 sensitivity, 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 darunavir. 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 Darunavir Mylan

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, blister and on the bottle after EXP. The expiry date refers to the last day of that month.

For blisters with plastic on one side and aluminium on the other: Do not store above 25°C.

For blisters with aluminium on both sides: This medicine does not require any special storage conditions.

For bottles: Once opened, use within 90 days. This medicine does not require any special storage conditons.

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 Darunavir Mylan contains

-The active substance is darunavir. Each tablet contains 800 milligram of darunavir.

-The other ingredients are colloidal anhydrous silica, cellulose microcrystalline, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide, macrogol and talc.

What Darunavir Mylan looks like and contents of the pack

Darunavir Mylan 800 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV8 on the other side.

Darunavir Mylan 800 mg film-coated tablets are available in blister packs containing 30 tablets and in plastic bottles containing 30, 60 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allee des Parcs

69 800 Saint Priest France

Manufacturers

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

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

België/Belgique/Belgien

Lietuva

Mylan bvba/sprl

BGP Products UAB

Tél/Tel: + 32 02 658 61 00

Tel: +370 5 205 1288

България

Luxembourg/Luxemburg

Майлан ЕООД

Mylan bvba/sprl

Тел: +359 2 44 55 400

Tel: + 32 02 658 61 00

 

(Belgique/Belgien)

Česká republika

Magyarország

Mylan Pharmaceuticals.s.r.o.

Mylan EPD Kft

Tel: + 420 222 004 400

Tel: + 36 1 465 2100

Danmark

Malta

Mylan AB

V.J. Salomone Pharma Ltd

Tlf: + 46 855 522 750

Tel: + 356 21 22 01 74

(Sverige)

 

Deutschland

Nederland

Mylan dura GmbH

Mylan BV

Tel: + 49-(0) 6151 9512 0

Tel: + 31 33 299 7080

Eesti

Norge

BGP Products Switzerland GmbH Eesti

Mylan AB

filiaal

Tel: + 46 855 522 750

Tel: + 372 6363 052

(Sverige)

Ελλάδα

Österreich

Generics Pharma Hellas ΕΠΕ

Arcana Arzneimittel GmbH

Τηλ: +30 210 993 6410

Tel: +43 1 416 2418

España

Polska

Mylan Pharmaceuticals, S.L

Mylan Sp. z.o.o.

Tel: + 34 900 102 712

Tel: + 48 22 546 64 00

France

Portugal

Mylan S.A.S

Mylan, Lda.

Tel: +33 4 37 25 75 00

Tel: + 351 21 412 72 56

Hrvatska

România

Mylan Hrvatska d.o.o.

A&G Med Trading SRL

Tel: +385 1 23 50 599

Tel: + 4021 332 49 91

Ireland

Slovenija

Generics [UK] Ltd.

GSP Proizvodi d.o.o.

Tel: + 44 1707 853000

Tel: + 386 1 236 31 85

(United Kingdom)

 

Ísland

Slovenská republika

Mylan AB

Mylan s.r.o.

Tel: + 46 855 522 750

Tel: +421 2 326 04 910 / +421 917 206 274

(Svíþjóð)

 

Italia

Suomi/Finland

Mylan S.p.A

Mylan OY

Tel: + 39 02 612 46921

Puh/Tel: + 358 9-46 60 03

Κύπρος

Sverige

Pharmaceutical Trading Co. Ltd.

Mylan AB

Τηλ: + 357 99403969

Tel: + 46 855 522 750

Latvija

United Kingdom

BGP Products SIA

Generics [UK] Ltd

Tel: +371 676 055 80

Tel: +44 1707 853000

Other sources of information

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

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