What is it and how is it used?

Noxafil works by killing or stopping the growth of some types of fungi that can cause infections in humans. It belongs to a group of medicines called triazole antifungal agents. These medicines are used to prevent and treat many different infections caused by fungi.

Noxafil can be used to treat the following types of fungal infections in adults:

  • 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 due to fungi 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.

Noxafil can be used to prevent fungal infections in patients whose immune systems may be weakened due to chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) or in patients using high-dose immunosuppressive therapy following hematopoietic stem cell transplant (HSCT).

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Noxafil

  • If you are allergic (hypersensitive) to posaconazole or to any of the other ingredients of Noxafil (see section 6 ?Further information? of this leaflet for list of ingredients).
  • If you are taking medicines that contain ergot alkaloids (used to treat migraines). Posaconazole can increase the amount of these medicines in the blood;, this can lead to severe reductions in blood flow to some parts of the body and damage tissues.
  • If you are taking any of the following medicines. Posaconazole can increase the amount of these medicines in the blood; this can lead to very serious disturbances in heart rhythm:
  • 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).
  • If you are taking simvastatin, lovastatin, atorvastatin or similar medicines (called HMG-CoA reductase inhibitors or statins) that are used to treat high cholesterol levels in the blood.

Please see the section ?Taking other medicines? for information on other medicines which may interact with Noxafil.

Take special care with Noxafil

Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor:

  • If you have ever had an allergic reaction to other medicines of the azole or triazole family, which include ketoconazole, fluconazole, itraconazole and voriconazole. Although there is no information on how being allergic to these azole antifungal agents will affect one?s sensitivity to posaconazole, caution should be used.
  • If you have or have had liver problems. You may need special blood tests to be done while you are taking Noxafil.
  • If you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of Noxafil.
  • If you have ever been told that you have any of the following conditions:
  • An abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
  • A weakness of the heart muscle or heart failure
  • A very slow heartbeat
  • Any heart rhythm disturbance
  • Any problem with amounts of potassium, magnesium or calcium in your blood.

Use in children
Please note that Noxafil is only for use in adults (older than 18 years of age).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Please 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 that must not be taken with posaconazole because of the risk of heart rhythm disturbances, 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).
There are other medicines that can sometimes be given while you are taking Noxafil but special care may be needed.

Certain medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in the blood. Similarly, certain medicines may decrease the effectiveness of Noxafil by decreasing the amount of posaconazole in the blood.
Medicines that can decrease the effectiveness of Noxafil are:

  • Rifabutin and rifampicin (used to treat certain infections). If you are already being treated with rifabutin, your blood counts and some possible side effects to rifabutin will need to be monitored.
  • Some medicines used to treat or prevent fits, such as phenytoin, carbamazepine, phenobarbital, primidone.
  • Efavirenz, which is 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 are:

  • Vincristine, vinblastine and other vinca alkaloids (used to treat cancer)
  • Ciclosporin (used in transplant surgery)
  • Tacrolimus and sirolimus (used in 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) and non nucleoside reverse transcriptase inhibitors (NNRTIs)
  • Midazolam, triazolam, alprazolam and some similar medicines called benzodiazepines (used as sedatives or muscle relaxants)
  • Diltiazem, verapamil, nifedipine, nisoldipine and some of the other medicines called calcium channel blockers (used to treat high blood pressure)
  • Digoxin (used to treat heart failure)
  • Sulfonylureas such as glipizide (used to treat high blood sugar).

Taking 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 use Noxafil during pregnancy unless you are told by your doctor. You should use effective contraception while you are taking Noxafil if you are a woman who could become pregnant. Contact your doctor immediately if you become pregnant while being treated with Noxafil.

Do not breast-feed while being treated with Noxafil, as it cannot be excluded that posaconazole may pass into breast milk.

Driving and using machines

Since posaconazole has been associated with some side effects (dizziness, sleepiness, blurred vision), which may interfere with such ability, please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.

Important information about some of the ingredients of Noxafil
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.

How is it used?

Always take Noxafil exactly as your doctor has told you. 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 usual 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 after a meal or a nutritional drink.

Indication Usual dose and length of treatment Treatment of refractory Fungal Infections Invasive aspergillosis, Fusariosis, ChromoblastomycosisMycetoma, Coccidioidomycosis The usual dose is 200 mg one 5 ml spoonful taken four times daily. Alternatively, if recommended by your doctor, you may take 400 mg two 5 ml spoonfuls twice a day provided that you are 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. Take 200 mg one 5 ml spoonful three times a day. Prevention of serious Fungal 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.

What are possible side effects?

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

Some of these side effects can be serious and may require urgent medical attention. Please consult your doctor immediately if you notice any of the following:

Possible side effects listed below are grouped by frequency of occurrence Very common Common Uncommon Rare Very rare Not known affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data

Common side effects:
Abnormal levels of salts in the blood (e.g. could experience confusion and weakness).

Uncommon side effects:
Anaemia, thrombocytopenia (a blood disease characterized by an abnormally small number of platelets in the blood, which may lead to bleeding), leukopenia (a blood disease characterized by lower than the normal amount of white blood cells), eosinophilia (an abnormal increase in the number of a specific type of white blood cell called eosinophils, which often accompanies inflammatory conditions), Allergic reaction,
Convulsions, a problem with the functioning of all the nerves in the body,
Irregular heartbeat, abnormal electrocardiogram, high or low blood pressure,
Inflammation of the pancreas (e.g. intense stomach pain),
Failure of the liver (e.g.coma), liver damage, yellow colour of the skin or the eyes, inflammation of the liver with or without bile obstruction,
Enlargement of both the liver and spleen (e.g. feeling mass under the ribs), liver tenderness, Failure of the kidneys (e.g. urine increase or decrease, discoloured urine, pain while urinating).

Rare side effects:
Pneumonia (e.g. shortness of breath and discoloured phlegm), high blood pressure in the pulmonary artery which can irrevocably damage the lungs and heart,
Unusual blood clotting, prolonged bleeding,
Severe allergic reactions, including widespread blistering rash and skin peeling,
Altered brain function (such as hearing voices or seeing things that are not there), fainting,

Problem thinking or talking, an abnormal tremor consisting of involuntary jerking movements,

especially in the hands, frequently occurring with impending hepatic coma and altered brain function,

Stroke (e.g. pain, weakness, numbness, or tingling in the limbs),
A blind or dark spot in the visual field,
Heart failure or heart attack, heart rhythm disorders, with sudden death, absence of the heart beat leading to oxygen lack and eventually to death,
Blood clots in limbs (e.g. intense pain or swelling), or blood clots in lungs (e.g. shortness of breath, pain while breathing),
Bleeding into the gut (e.g. vomiting blood, blood in the stool), intestinal obstruction: blockage of the intestine (especially the ileum) that prevents the contents of the intestine from passing to the lower bowel, which often results in abdominal bloating, vomiting, severe constipation, loss of appetite, and cramps,
Haemolytic uraemic syndrome (a condition characterized by the breakup of red blood cells (hemolysis) with or without kidney failure), pancytopenia (an abnormal deficiency in all blood cells (red blood cells, white blood cells and platelets)),
Large purple discolourations on the skin,
Swelling of the face or tongue.

The other side effects listed below are given with an estimation of the frequency with which they may occur with Noxafil.

Common side effects:
An abnormal sensation of the skin, such as numbness, tingling, pricking, burning, or creeping on the skin,
Headache, dizziness,
Sleepiness,
Nausea (feeling or being sick), loss of appetite, stomach pain, diarrhoea, upset stomach, vomiting, passing gas, dry mouth,
Abnormal liver function results in blood test,
A decrease in white blood cells in blood tests (that can increase the risk of infections), Weakness, tiredness,
Rash,
Fever.

Uncommon side effects:
Enlargement of lymph glands,
Reduced sense of touch or sensation, or a partial loss of sensitivity to sensory stimuli,, tremor, High blood levels of sugar,
Blurred vision,
Temporary hair loss,
Mouth ulcers,
Shivering, generally feeling unwell,
Scattered body pain, including in muscles and joints, back pain,
Water retention (e.g. body swelling),
Menstrual disorder (e.g. abnormal bleeding from the vagina),
Change in effectiveness of some medicines.

Rare side effects:

Depression,
Double vision,

Breast pain,
Poor functioning of the adrenal gland (e.g. weakness, fatigue, loss of appetite, skin discolouration), decreased blood levels of hormones that are secreted by the pituitary gland, and that affect the function of the male or female gonads,
Hearing problems.

Some patients have also reported feeling confused after taking Noxafil.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Noxafil 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 left over suspension to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further 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:

SP Europe
Rue de Stalle, 73
B-1180 Bruxelles
Belgium

Manufacturer:
SP S.A.
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:

BelgiëBelgiqueBelgien Rue de StalleStallestraat 73 B-1180 BruxellesBrusselBrüssel TélTel 32-02 370 92 11 LuxembourgLuxemburg Rue de Stalle 73 B-1180 BruxellesBrüssel BelgiqueBelgien TélTel 32-02 370 92 11

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