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 leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/05/320/004.
Noxafil 300 mg concentrate for solution for infusion
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.
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:
Noxafil 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 use Noxafil
Do not use Noxafil
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:
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:
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 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:
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.
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
The maximum recommended daily dose of this medicinal product contains 924 mg sodium (found in table salt). This is equivalent to 46 % of the adult recommended maximum daily dietary intake for sodium.
Talk to your pharmacist or doctor if you need Noxafil 300 mg concentrate for solution for infusion on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.
Noxafil contains cyclodextrin
This medicine contains 6,680 mg of cyclodextrin per vial.
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:
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:
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
Not known: frequency cannot be estimated from the available data
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Noxafil
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
Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in September 2020.
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, 2020. All rights reserved.
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