Noxafil 100 mg Tablets

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 to treat the following types of fungal infections in patients 13 years of age or older:

• Infections caused by fungi of the Aspergillus family that have not improved during treatment with the antifungal medicines amphotericin B, itraconazole or voriconazole, or when these
• Infections of the mouth or throat area caused by fungi of the Candida family that have not improved during treatment with the antifungal medicines amphotericin B, itraconazole or voriconazole, or when these medicines had to be stopped.
• Infections caused by fungi of the Fusarium family that have not improved during treatment of amphotericin B or other therapy, or when such therapy had to be stopped.
• Infections caused by fungi that cause the conditions known as zygomycosis, cryptococcosis, chromoblastomycosis and mycetoma, that have not improved during treatment with itraconazole, or other therapy, or when such therapy had to be stopped.
• Infections caused by the condition known as coccidioidomycosis.
• NOXAFIL can be used to prevent fungal infections in patients whose immune systems may be weakened due to other medicines or diseases.

Do not take NOXAFIL if:

• you are hypersensitive (allergic) to posaconazole or to any of the other ingredients of NOXAFIL
• you are taking medicines that contain ergot alkaloids (used to treat migraines). NOXAFIL can increase the blood levels of these medicines, which can lead to severe reductions in blood flow to some parts of the body and damage tissues
• you are taking any of the following medicines. NOXAFIL can increase the blood levels of these medicines, which 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)
• quinidine (used to treat abnormal heart rhythms)
• you are taking simvastatin, lovastatin, atorvastatin and some similar medicines (called HMG - CoA reductase inhibitors or statins) that are used to treat high cholesterol levels in the blood
• you are pregnant or breastfeeding.

Warnings and precautionsTalk 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).
• are taking venetoclax (a medicine 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
Children under the age of 13 must not use NOXAFIL, unless instructed to do so by a doctor.

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.

How much to take
NOXAFIL Tablets 100 mg
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.

• 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.

Not all side effects reported for NOXAFIL are included in this leaflet. Should your general health worsen of if you experience any untoward effects while taking NOXAFIL, please consult your healthcare provider for advice. NOXAFIL Tablets can have 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 side effects (occurring in at least 1 in 100 patients) are:

• a decrease in white blood cells (that can include the risk of infections)
• loss of appetite, electrolyte imbalance, low calcium
• headache, dizziness, numbness or tingling, sleepiness
• stomach pain, diarrhoea, upset stomach, wind, dry mouth, feeling or being sick, vomiting, constipation
• liver function tests that are higher than normal (including AST, ALT, alkaline phosphatase, GGT and bilirubin)
• rash, itching
• weakness, tiredness, fever

Other side effects that were related to treatment of NOXAFIL during clinical trials were: altered concentration of other medicinal products increased liver enzymes, nausea, rash and vomiting, excess bilirubin in the blood. Uncommon and rare treatment related adverse events that were reported during clinical trials include: inability of the adrenal gland to function normally, allergic and/or hypersensitivity reactions. Some patients have also reported feeling confused after taking NOXAFIL, the frequency of this is not known. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in tis leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NOXAFIL Tablets.

How to store NOXAFIL Tablet 100 mg
Store at or below 30 °C. Store all medicines out of the reach of children. Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist. Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).