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Noxafil (posaconazole) – Package leaflet - J02AC04

Updated on site: 08-Oct-2017

Medication nameNoxafil
ATC CodeJ02AC04
Substanceposaconazole
ManufacturerMerck Sharp

Package leaflet: Information for the user

Noxafil 40 mg/mL oral suspension posaconazole

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 Noxafil is and what it is used for

2.What you need to know before you take Noxafil

3.How to take Noxafil

4.Possible side effects

5.How to store Noxafil

6.Contents of the pack and other information

1.What Noxafil is and what it is used for

Noxafil contains a medicine called posaconazole. This belongs to a group of medicines called “antifungals”. It is used to prevent and treat many different fungal infections.

This medicine works by killing or stopping the growth of some types of fungi that can cause infections.

Noxafil can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them:

infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;

infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped;

infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;

infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.

Infections in the mouth or throat area (known as “thrush”) caused by fungi called Candida, which were not previously treated.

This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:

patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)

patients having “high-dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).

2. What you need to know before you take Noxafil

Do not take Noxafil if:

you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).

you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.

Do not take Noxafil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Noxafil.

See “Other medicines and Noxafil” below for more information including information on other medicines which may interact with Noxafil.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Noxafil if you:

have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole.

have or have ever had liver problems. You may need to have blood tests while you are taking this medicine.

develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.

have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval

have a weakness of the heart muscle or heart failure

have a very slow heartbeat

have heart rhythm disturbance

have any problem with potassium, magnesium or calcium levels in your blood

are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Noxafil.

If you develop severe diarrhoea or vomiting (being sick) while taking Noxafil, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly. See Section 4 for more information.

Children

Noxafil should not be used in children (17 years of age and younger).

Other medicines and Noxafil

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

Do not take Noxafil if you are taking any of the following:

terfenadine (used to treat allergies)

astemizole (used to treat allergies)

cisapride (used to treat stomach problems)

pimozide (used to treat symptoms of Tourette's and mental illness)

halofantrine (used to treat malaria)

quinidine (used to treat abnormal heart rhythms).

Noxafil can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm:

any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines. Noxafil can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.

a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.

Do not take Noxafil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Other medicines

Look at the list of medicines given above that must not be taken while you are taking Noxafil. In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with Noxafil. Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).

Certain medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in the blood.

The following medicines may decrease the effectiveness of Noxafil by decreasing the amount of Noxafil in the blood:

rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.

some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbital or primidone).

efavirenz and fosamprenavir used to treat HIV infection.

medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.

Noxafil may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood. These medicines include:

vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)

ciclosporin (used during or after transplant surgery)

tacrolimus and sirolimus (used during or after transplant surgery)

rifabutin (used to treat certain infections)

medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given with ritonavir)

midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)

diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure)

digoxin (used to treat heart failure)

Glipizide or other “sulfonylureas” (used to treat high blood sugar).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Noxafil.

Noxafil with food and drink

To improve absorption of posaconazole, whenever possible it should be taken during or immediately after food or a nutritional drink (see section 3 “How to take Noxafil”). There is no information on the effect of alcohol on posaconazole.

Pregnancy and breast-feeding

Tell your doctor if you are or think you are pregnant before you start to take Noxafil. Do not take Noxafil if you are pregnant unless you are told to by your doctor.

If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine. If you become pregnant while you are taking Noxafil, contact your doctor straight away.

Do not breast-feed while taking Noxafil. This is because small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while taking Noxafil, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor.

Noxafil contains glucose

Noxafil contains approximately 1.75 g of glucose per 5 mL of suspension. You should not take this medicine if you have a condition called glucose-galactose malabsorption and should take note of this amount of glucose if you need to watch your sugar intake for any reason.

3.How to take Noxafil

Do not switch between taking Noxafil tablets and Noxafil oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will monitor your response and condition to determine how long Noxafil needs to be given and whether any change is needed to your daily dose.

The table below shows the recommended dose and length of treatment which depend on the type of infection that you have and may be individually adapted for you by your doctor. Do not adapt your dose yourself before consulting your doctor or change your treatment regime.

Whenever possible you should take posaconazole during or immediately after food or a nutritional drink.

Indication

Recommended dose and length of treatment

Treatment of refractory Fungal

The recommended dose is 200 mg (one 5 mL spoonful) taken

Infections (Invasive aspergillosis,

four times daily.

Fusariosis,

Alternatively, if recommended by your doctor, you may take

Chromoblastomycosis/Mycetoma,

400 mg (two 5 mL spoonfuls) twice a day provided that you are

Coccidioidomycosis)

able to take both doses during or after food or a nutritional

 

drink.

First time treatment of Thrush

On the first day of treatment take 200 mg (one 5 mL spoonful)

 

once. After the first day, take 100 mg (2.5 mL) once a day.

Prevention of serious Fungal

Take 200 mg (one 5 mL spoonful) three times a day.

Infections

 

If you take more Noxafil than you should

If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.

If you forget to take Noxafil

If you have missed a dose, take it as soon as you remember and then carry on as before. However, if it is almost time for your next dose, take your dose when it is due. Do not take a double dose to make up for a forgotten dose.

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

4.Possible side effects

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

Serious side effects

Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

nausea or vomit (feeling or being sick), diarrhoea

signs of liver problems - these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests

allergic reaction

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Common: the following may affect up to 1 in 10 people

a change in the salt level in your blood shown in blood tests - signs include feeling confused or weak

abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking or burning

headache

low potassium levels – shown up in blood tests

low magnesium levels – shown up in blood tests

high blood pressure

loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste

heartburn (a burning sensation in the chest rising up to the throat)

low levels of “neutrophils” a type of white blood cell (neutropenia) –this can make you more likely to get infections and be shown up in blood tests

fever

feeling weak, dizzy, tired or sleepy

rash

itching

constipation

rectal discomfort

Uncommon: the following may affect up to 1 in 100 people

anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests

low level of platelets (thrombocytopenia) shown in blood tests – this may lead to bleeding

low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests – this can make you more likely to get infections

high level of “eosinophils” a type of white blood cell (eosinophilia) – this can happen if you have inflammation

inflammation of the blood vessels

heart rhythm problems

fits (convulsions)

nerve damage (neuropathy)

abnormal heart rhythm – shown up on a heart trace (ECG), palpitations, slow or fast heartbeat, high or low blood pressure

low blood pressure

inflammation of the pancreas (pancreatitis) – this may cause severe stomach pain

oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain

severe kidney problems – signs include passing more or less urine, that is a different colour than usual

high blood levels of creatinine – shown in blood tests

cough, hiccups

nose bleeds

severe sharp chest pain when breathing in (pleurritic pain)

swelling of lymph glands (lymphadenopathy)

reduced feeling of sensitivity especially on the skin

tremor

high or low blood sugar levels

blurred vision, sensitivity to light

hair loss (alopecia)

mouth ulcers

shivering, feeling generally unwell

pain, back or neck pain, pain in arms or legs

water retention (oedema)

menstrual problems (abnormal vaginal bleeding)

inability to sleep (insomnia)

being completely or partially unable to talk

swelling of the mouth

abnormal dreams, or difficulty sleeping

problems with co-ordination or balance

mucosal inflammation

stuffy nose

difficulty breathing

chest discomfort

feeling bloated

mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain

belching

feeling jittery

Rare: the following may affect up to 1 in 1,000 people

pneumonia – signs include feeling short of breath and producing discoloured phlegm

high blood pressure in the blood vessels in the lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart

blood problems such as unusual blood clotting or prolonged bleeding

severe allergic reactions, including widespread blistering rash and skin peeling

mental problems such as hearing voices or seeing things that are not there

fainting

having problems thinking or talking, having jerking movements, especially in your hands that you cannot control

stroke – signs include pain, weakness, numbness, or tingling in the limbs

having a blind or dark spot in your field of vision

heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death

blood clots in your legs (deep vein thrombosis) – signs include intense pain or swelling of the legs

blood clots in your lungs (pulmonary embolism) – signs include feeling short of breath or pain while breathing

bleeding into your stomach or gut – signs include vomiting blood or passing blood in your stool

a blockage in your gut (intestinal obstruction) especially in the “ileum”. The blockage will prevent the contents of your intestine from passing through to the lower bowel signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps

“haemolytic uraemic syndrome” when red blood cells breakup (hemolysis) which may happen with or without kidney failure

“pancytopenia” low level of all blood cells (red and white blood cells and platelets) shown in blood tests

large purple discolourations on the skin (thrombotic thrombocytopenic purpura)

swelling of the face or tongue

depression

double vision

breast pain

adrenal glands not working properly – this may cause weakness, tiredness, loss of appetite, skin discolouration

pituitary gland not working properly – this may cause low blood levels of some hormones that affect the function of the male or female sex organs

hearing problems

Some patients have also reported feeling confused after taking Noxafil, the frequency of this is not known.

Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.

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 Noxafil

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 label. The expiry date refers to the last day of that month.

Do not freeze.

If you have any suspension left in a bottle more than four weeks after it was first opened, you should not use this medicine. Please return the bottle containing any leftover suspension to your pharmacist.

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

6. Contents of the pack and other information

What Noxafil contains

-The active substance in Noxafil is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.

-The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.

What Noxafil looks like and contents of the pack

Noxafil is a white, cherry flavoured, 105 mL oral suspension packaged in amber glass bottles. A measuring spoon is provided with each bottle for measuring 2.5 and 5 mL doses of the oral suspension.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Manufacturer

Cenexi HSC

2, rue Louis Pasteur F-14200 Hérouville St Clair France

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

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel : 0800 38 693 (+32 (0)2 776 62 11)

Tel. + 370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel : +32 (0)2 776 62 11

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 44 82 4000

Tel.: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+ 49 (0) 89 4561 2612)

Tel: 0800 9999000 (+31 23 5153153)

e-mail@msd.de

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: + 372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél. +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: + 371-67364224 msd_lv@merck.com

This leaflet was last revised in

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 446 5700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel.: + 40 21 529 2900 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

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

Noxafil 100 mg gastro-resistant tablets posaconazole

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 Noxafil is and what it is used for

2.What you need to know before you take Noxafil

3.How to take Noxafil

4.Possible side effects

5.How to store Noxafil

6.Contents of the pack and other information

1. What Noxafil is and what it is used for

Noxafil contains a medicine called posaconazole. This belongs to a group of medicines called “antifungals”. It is used to prevent and treat many different fungal infections.

This medicine works by killing or stopping the growth of some types of fungi that can cause infections.

Noxafil can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them:

infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;

infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped;

infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;

infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.

This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:

patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)

patients having “high-dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).

2. What you need to know before you take Noxafil

Do not take Noxafil if:

you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).

you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.

Do not take Noxafil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Noxafil.

See “Other medicines and Noxafil” below for more information including information on other medicines which may interact with Noxafil.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Noxafil if you:

have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole.

have or have ever had liver problems. You may need to have blood tests while you are taking this medicine.

develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.

have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval

have a weakness of the heart muscle or heart failure

have a very slow heartbeat

have heart rhythm disturbance

have any problem with potassium, magnesium or calcium levels in your blood

are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Noxafil.

If you develop severe diarrhoea or vomiting (being sick) while taking Noxafil, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly. See Section 4 for more information.

Children

Noxafil should not be used in children (17 years of age and younger).

Other medicines and Noxafil

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

Do not take Noxafil if you are taking any of the following:

terfenadine (used to treat allergies)

astemizole (used to treat allergies)

cisapride (used to treat stomach problems)

pimozide (used to treat symptoms of Tourette's and mental illness)

halofantrine (used to treat malaria)

quinidine (used to treat abnormal heart rhythms).

Noxafil can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm:

any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines. Noxafil can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.

a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.

Do not take Noxafil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Other medicines

Look at the list of medicines given above that must not be taken while you are taking Noxafil. In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with Noxafil. Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).

Certain medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in the blood.

The following medicines may decrease the effectiveness of Noxafil by decreasing the amount of Noxafil in the blood:

rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.

some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbital or primidone).

efavirenz and fosamprenavir used to treat HIV infection.

Noxafil may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood. These medicines include:

vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)

ciclosporin (used during or after transplant surgery)

tacrolimus and sirolimus (used during or after transplant surgery)

rifabutin (used to treat certain infections)

medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given with ritonavir)

midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)

diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure)

digoxin (used to treat heart failure)

Glipizide or other “sulfonylureas” (used to treat high blood sugar).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Noxafil.

Pregnancy and breast-feeding

Tell your doctor if you are or think you are pregnant before you start to take Noxafil. Do not take Noxafil if you are pregnant unless you are told to by your doctor.

If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine. If you become pregnant while you are taking Noxafil, contact your doctor straight away.

Do not breast-feed while taking Noxafil. This is because small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while taking Noxafil, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor.

3. How to take Noxafil

Do not switch between taking Noxafil tablets and Noxafil oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day, thereafter.

The length of treatment may depend on the type of infection that you have and may be individually adapted for you by your doctor. Do not adapt your dose yourself before consulting your doctor or change your treatment regimen.

Taking this medicine

Swallow the tablet whole with some water.

Do not crush, chew, break or dissolve the tablet.

Tablets may be taken with or without food.

If you take more Noxafil than you should

If you think that you may have taken too much Noxafil, talk to a doctor or go to the hospital straight away.

If you forget to take Noxafil

If you forget a dose, take it as soon as you remember it.

However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule.

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Serious side effects

Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

nausea or vomit (feeling or being sick), diarrhoea

signs of liver problems - these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests

allergic reaction

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Common: the following may affect up to 1 in 10 people

a change in the salt level in your blood shown in blood tests - signs include feeling confused or weak

abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking or burning

headache

low potassium levels – shown up in blood tests

low magnesium levels – shown up in blood tests

high blood pressure

loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste

heartburn (a burning sensation in the chest rising up to the throat)

low levels of “neutrophils” a type of white blood cell (neutropenia) –this can make you more likely to get infections and be shown up in blood tests

fever

feeling weak, dizzy, tired or sleepy

rash

itching

constipation

rectal discomfort

Uncommon: the following may affect up to 1 in 100 people

anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests

low level of platelets (thrombocytopenia) shown in blood tests – this may lead to bleeding

low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests – this can make you more likely to get infections

high level of “eosinophils” a type of white blood cell (eosinophilia) – this can happen if you have inflammation

inflammation of the blood vessels

heart rhythm problems

fits (convulsions)

nerve damage (neuropathy)

abnormal heart rhythm – shown up on a heart trace (ECG), palpitations, slow or fast heartbeat, high or low blood pressure

low blood pressure

inflammation of the pancreas (pancreatitis) – this may cause severe stomach pain

oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain

severe kidney problems – signs include passing more or less urine, that is a different colour than usual

high blood levels of creatinine – shown in blood tests

cough, hiccups

nose bleeds

severe sharp chest pain when breathing in (pleurritic pain)

swelling of lymph glands (lymphadenopathy)

reduced feeling of sensitivity especially on the skin

tremor

high or low blood sugar levels

blurred vision, sensitivity to light

hair loss (alopecia)

mouth ulcers

shivering, feeling generally unwell

pain, back or neck pain, pain in arms or legs

water retention (oedema)

menstrual problems (abnormal vaginal bleeding)

inability to sleep (insomnia)

being completely or partially unable to talk

swelling of the mouth

abnormal dreams, or difficulty sleeping

problems with co-ordination or balance

mucosal inflammation

stuffy nose

difficulty breathing

chest discomfort

feeling bloated

mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain

belching

feeling jittery

Rare: the following may affect up to 1 in 1,000 people

pneumonia – signs include feeling short of breath and producing discoloured phlegm

high blood pressure in the blood vessels in the lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart

blood problems such as unusual blood clotting or prolonged bleeding

severe allergic reactions, including widespread blistering rash and skin peeling

mental problems such as hearing voices or seeing things that are not there

fainting

having problems thinking or talking, having jerking movements, especially in your hands that you cannot control

stroke – signs include pain, weakness, numbness, or tingling in the limbs

having a blind or dark spot in your field of vision

heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death

blood clots in your legs (deep vein thrombosis) – signs include intense pain or swelling of the legs

blood clots in your lungs (pulmonary embolism) – signs include feeling short of breath or pain while breathing

bleeding into your stomach or gut – signs include vomiting blood or passing blood in your stool

a blockage in your gut (intestinal obstruction) especially in the “ileum”. The blockage will prevent the contents of your intestine from passing through to the lower bowel signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps

“haemolytic uraemic syndrome” when red blood cells breakup (hemolysis) which may happen with or without kidney failure

“pancytopenia” low level of all blood cells (red and white blood cells and platelets) shown in blood tests

large purple discolourations on the skin (thrombotic thrombocytopenic purpura)

swelling of the face or tongue

depression

double vision

breast pain

adrenal glands not working properly – this may cause weakness, tiredness, loss of appetite, skin discolouration

pituitary gland not working properly – this may cause low blood levels of some hormones that affect the function of the male or female sex organs

hearing problems

Some patients have also reported feeling confused after taking Noxafil, the frequency of this is not known.

Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.

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 Noxafil

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 blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

What Noxafil contains

The active substance in Noxafil is posaconazole. Each tablet contains 100 mg of posaconazole.

The other ingredients are: hypromellose acetate succinate; cellulose, microcrystalline; hydroxypropylcellulose (E463); silica dental type; croscarmellose sodium; magnesium stearate, polyvinyl alcohol, macrogol 3350 , titanium dioxide (E171), talc, iron oxide yellow (E172).

What Noxafil looks like and contents of the pack

Noxafil gastro-resistant tablets are yellow-coated and capsule-shaped, debossed “100” on one side packaged in a blister in cartons of 24 (2x12) or 96 (8x12) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Manufacturer

SP Labo N.V.

Industriepark 30

B-2220 Heist-op-den-Berg

Belgium

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

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel : 0800 38 693 (+32 (0)2 776 62 11)

Tel. + 370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel : +32 (0)2 776 62 11

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 44 82 4000

Tel.: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+ 49 (0) 89 4561 2612)

Tel: 0800 9999000 (+31 23 5153153)

e-mail@msd.de

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: + 372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Ελλάδα

Österreich

MSD Α.Φ.Β.Ε.Ε.

Merck Sharp & Dohme Ges.m.b.H.

Τηλ: +30 210 98 97 300

Tel: +43 (0) 1 26 044

dpoc_greece@merck.com

msd-medizin@merck.com

España

Polska

Merck Sharp & Dohme de España, S.A.

MSD Polska Sp. z o.o.

Tel: +34 91 321 06 00

Tel.: +48 22 549 51 00

msd_info@merck.com

msdpolska@merck.com

France

Portugal

MSD France

Merck Sharp & Dohme, Lda

Tél. +33 (0) 1 80 46 40 40

Tel: +351 21 446 5700

 

clic@merck.com

Hrvatska

România

Merck Sharp & Dohme d.o.o.

Merck Sharp & Dohme Romania S.R.L.

Tel: + 385 1 6611 333

Tel.: + 40 21 529 2900

croatia_info@merck.com

msdromania@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: + 371-67364224 msd_lv@merck.com

This leaflet was last revised in

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Other sources of information

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

Package leaflet: Information for the user

Noxafil 300 mg concentrate for solution for infusion posaconazole

Read all of this leaflet carefully before you start using 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 Noxafil is and what it is used for

2.What you need to know before you use Noxafil

3.How to use Noxafil

4.Possible side effects

5.How to store Noxafil

6.Contents of the pack and other information

1. What Noxafil is and what it is used for

Noxafil contains a medicine called posaconazole. This belongs to a group of medicines called “antifungals”. Noxafil is used to prevent and treat many different fungal infections.

Noxafil works by killing or stopping the growth of some types of fungi that can cause infections.

Noxafil can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them:

infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;

infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped;

infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;

infections caused by a fungus called Coccidioides. that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.

Noxafil can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:

patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)

patients having “high-dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).

2. What you need to know before you use Noxafil

Do not use Noxafil if:

you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).

you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.

Do not use Noxafil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Noxafil.

See “Other medicines and Noxafil” below for information on other medicines which may interact with Noxafil.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Noxafil if you:

have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole.

have or have ever had liver problems. You may need to have blood tests while you are taking Noxafil.

have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval

have a weakness of the heart muscle or heart failure

have a very slow heartbeat

have heart rhythm disturbance

have any problem with potassium, magnesium or calcium levels in your blood

are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Noxafil.

Children

Noxafil should not be used in children (17 years of age and younger).

Other medicines and Noxafil

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

Do not take Noxafil if you are taking any of the following:

terfenadine (used to treat allergies)

astemizole (used to treat allergies)

cisapride (used to treat stomach problems)

pimozide (used to treat symptoms of Tourette's disorder)

halofantrine (used to treat malaria)

quinidine (used to treat abnormal heart rhythms).

Noxafil can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm:

any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines. Noxafil can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.

a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.

Do not take Noxafil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Noxafil.

Other medicines

Look at the list of medicines given above that must not be taken while you are taking Noxafil. In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with posaconazole. Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).

Certain medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in the blood.

The following medicines may decrease the effectiveness of Noxafil by decreasing the amount of Noxafil in the blood:

rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.

some medicines used to treat or prevent fits including: phenytoin, carbamazepine, phenobarbital or primidone.

efavirenz and fosamprenavir used to treat HIV infection.

Noxafil may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood. These medicines include:

vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)

ciclosporin (used during or after transplant surgery)

tacrolimus and sirolimus (used during or after transplant surgery)

rifabutin (used to treat certain infections)

medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given with ritonavir)

midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)

diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure)

digoxin (used to treat heart failure)

Glipizide or other “sulfonylureas” (used to treat high blood sugar)

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Noxafil.

Pregnancy and breast-feeding

Tell your doctor if you are or think you are pregnant before you start to take Noxafil. Do not use Noxafil if you are pregnant unless you are told to by your doctor.

If you are a woman who could become pregnant you should use effective contraception while you are using Noxafil. If you become pregnant while you are using Noxafil, contact your doctor straight away.

Do not breast-feed while using Noxafil. This is because small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while taking Noxafil, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor.

Noxafil contains sodium

This medicinal product contains 462 mg (20 mmol) sodium per dose. This should be taken into consideration by patients on a controlled sodium diet.

3.How to use Noxafil

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

The recommended dose is 300 mg twice a day on the first day, then 300 mg once a day, thereafter.

Noxafil concentrate for solution for infusion will be diluted to the correct concentration by your pharmacist or nurse.

Noxafil concentrate for solution for infusion will always be prepared and given to you by a healthcare professional.

You will be given Noxafil:

through a plastic tube placed in your vein (intravenous infusion)

usually over 90 minutes

The length of treatment may depend on the type of infection that you have or the length of time your immune system is not working properly and may be individually adapted for you by your doctor. Do not adapt your dose yourself before consulting your doctor or change your treatment regimen.

If a dose of Noxafil has been forgotten

As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However, tell your doctor or pharmacist if you think that a dose has been forgotten.

When Noxafil treatment is stopped by your doctor you should not experience any effects.

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

4. Possible side effects

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

Serious side effects

Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

nausea or vomit (feeling or being sick), diarrhoea,

signs of liver problems, these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests

allergic reaction

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Common: the following may affect up to 1 in 10 people

a change in the salt level in your blood shown in blood tests signs include feeling confused or weak

abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking, or burning

swelling, redness, and tenderness along the vein in which Noxafil was given

headache

low potassium levels – shown up in blood tests

low magnesium levels – shown up in blood tests

high blood pressure

loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste

heartburn (a burning sensation in the chest rising up to the throat)

low levels of “neutrophils” a type of white blood cell (neutropenia) – this can make you more likely to get infections and be shown up in blood tests

fever

feeling weak, dizzy, tired, or sleepy

rash

itching

constipation

rectal discomfort

Uncommon: the following may affect up to 1 in 100 people

anaemia- signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests

low level of platelets (thrombocytopenia) shown in blood tests – this may lead to bleeding

low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests – this can make you more likely to get infections

high level of “eosinophils” a type of white blood cell (eosinophilia) – this can happen if you have inflammation

inflammation of the blood vessels

heart rhythm problems

fits (convulsions)

nerve damage (neuropathy)

abnormal heart rhythm – shown up on a heart trace (ECG), palpitations, slow or fast heartbeat, high or low blood pressure

low blood pressure

inflammation of the pancreas (pancreatitis) – this may cause severe stomach pain

oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain

severe kidney problems – signs include passing more or less urine that is a different colour than usual

high blood levels of creatinine – shown in blood tests

cough, hiccups

nose bleeds

severe sharp chest pain when breathing in (pleurritic pain)

swelling of lymph glands (lymphadenopathy)

reduced feeling of sensitivity especially on the skin

tremor

high or low blood sugar levels

blurred vision, sensitivity to light

hair loss (alopecia)

mouth ulcers

shivering, feeling generally unwell

pain, back or neck pain, pain in arms or legs

water retention (oedema)

menstrual problems (abnormal vaginal bleeding)

inability to sleep (insomnia)

being completely or partially unable to talk

swelling of the mouth

abnormal dreams, or difficulty sleeping

problems with co-ordination or balance

mucosal inflammation

stuffy nose

difficulty breathing

chest discomfort

feeling bloated

mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain

belching

feeling jittery

inflammation or pain at injection site

Rare: the following may affect up to 1 in 1,000 people

pneumonia – signs include feeling short of breath and producing discoloured phlegm

high blood pressure in the blood vessels in the lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart

blood problems such as unusual blood clotting or prolonged bleeding

severe allergic reactions, including widespread blistering rash and skin peeling

mental problems such as hearing voices or seeing things that are not there

fainting

having problems thinking or talking, having jerking movements, especially in your hands that you cannot control

stroke – signs include pain, weakness, numbness, or tingling in the limbs

having a blind or dark spot in your field of vision

heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death

blood clots in your legs (deep vein thrombosis) – signs include intense pain or swelling of the legs

blood clots in your lungs (pulmonary embolism) – signs include feeling short of breath or pain while breathing

bleeding into your stomach or gut – signs include vomiting blood or passing blood in your stool

a blockage in your gut (intestinal obstruction) especially in the “ileum”. The blockage will prevent the contents of your intestine from passing through to the lower bowel signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps

“haemolytic uraemic syndrome” when red blood cells breakup (hemolysis) which may happen with or without kidney failure

“pancytopenia” low level of all blood cells (red and white blood cells and platelets) shown in blood tests

large purple discolourations on the skin (thrombotic thrombocytopenic purpura)

swelling of the face or tongue

depression

double vision

breast pain

adrenal glands not working properly – this may cause weakness, tiredness, loss of appetite, skin discolouration

pituitary gland not working properly – this may cause low blood levels of some hormones that affect the function of the male or female sex organs

hearing problems

Some patients have also reported feeling confused after using Noxafil, the frequency of this is not known.

Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.

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 Noxafil

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 label. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C–8 C).

Once prepared, the product should be used immediately. If not used immediately, the solution can be stored up to 24 hours at 2°C-8°C (in a refrigerator). This medicinal product is for single use only and any unused solution should be discarded.

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

6. Contents of the pack and other information

What Noxafil contains

The active substance is posaconazole. Each vial contains 300 mg of posaconazole.

The other ingredients are: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid (concentrated), sodium hydroxide, water for injections.

What Noxafil looks like and contents of the pack

Noxafil concentrate for solution for infusion is a clear, colourless to yellow liquid. Variations of colour within this range do not affect the quality of the product.

This medicine is available in a single use glass vial closed with bromobutyl rubber stopper and aluminium seal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Manufacturer

SP Labo N.V.

Industriepark 30

B-2220 Heist-op-den-Berg

Belgium

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

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel : 0800 38 693 (+32 (0)2 776 62 11)

Tel. + 370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3737 info-msdbg@merck.com

Česká republika

Merck Sharp & Dohme s.r.o. Tel: +420 233 010 111 dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS Tlf: + 45 44 82 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+ 49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ Tel.: + 372 6144 200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél. +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL Tél/Tel : +32 (0)2 776 62 11 dpoc_belux@merck.com

Magyarország

MSD Pharma Hungary Kft. Tel.: +36 1 888 5300 hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited Tel.: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 446 5700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel.: + 40 21 529 2900 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: + 371-67364224 msd_lv@merck.com

This leaflet was last revised in

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Other sources of information

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

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Administration instructions for Noxafil concentrate for solution for infusion

Equilibrate the refrigerated vial of Noxafil to room temperature.

Aseptically transfer 16.7 mL of posaconazole to an intravenous bag (or bottle) containing a compatible admixture diluent (see below for list of diluents) using the volume ranging from 150 mL to 283 mL depending on the final concentration to be achieved (not less than 1 mg/mL and not greater than 2 mg/mL).

Administer via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes. Noxafil concentrate for solution for infusion should not be given by bolus administration.

If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter with a volume to achieve a dilution of approximately 2 mg/mL. When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes.

Note: In clinical trials, multiple peripheral infusions given through the same vein resulted in infusion site reactions (see section 4.8).

Noxafil is for single use.

The following medicinal products can be infused at the same time through the same intravenous line (or cannula) as Noxafil concentrate for solution for infusion:

Amikacin sulfate

Caspofungin

Ciprofloxacin

Daptomycin

Dobutamine hydrochloride

Famotidine

Filgrastim

Gentamicin sulfate

Hydromorphone hydrochloride

Levofloxacin

Lorazepam

Meropenem

Micafungin

Morphine sulphate

Norepinephrine bitartrate

Potassium chloride

Vancomycin hydrochloride

Any products not listed in the table above should not be coadministered with Noxafil through the same intravenous line (or cannula).

The infusion solution should be inspected visually for particulate matter prior to administration. The solution of Noxafil ranges from colourless to pale yellow. Variations of colour within this range do not affect the quality of the product.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Noxafil must not be diluted with:

Lactated Ringer’s solution

5 % dextrose with Lactated Ringer’s solution

4.2 % sodium bicarbonate

This medicinal product must not be mixed with other medicinal products except those mentioned below:

5 % dextrose in water

0.9 % sodium chloride

0.45 % sodium chloride

5 % dextrose and 0.45 % sodium chloride

5 % dextrose and 0.9 % sodium chloride

5 % dextrose and 20 mEq KCl

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