Active ingredient
- posaconazole
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/05/320/001.
Noxafil 40mg/ml oral suspension
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.
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:
This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:
2. What you need to know before you take Noxafil
Do not take Noxafil if:
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:
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:
Noxafil can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm:
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:
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:
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 vs. Recommended dose and length of treatment
Treatment of refractory Fungal Infections (Invasive aspergillosis, Fusariosis, Chromoblastomycosis/Mycetoma, Coccidioidomycosis):
The recommended 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.
Prevention of serious Fungal Infections:
Take 200 mg (one 5 ml spoonful) three times a day
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:
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
Uncommon: the following may affect up to 1 in 100 people
Rare: the following may affect up to 1 in 1,000 people
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal
Ireland:
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5. How to store Noxafil
6. Contents of the pack and other information
What Noxafil contains
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
Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2017.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme Limited, 2017. All rights reserved.
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