- mycophenolate mofetil hydrochloride
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/1/96/005/005.
Cellcept 500mg powder for concentrate for solution for infusion
Package leaflet: Information for the user
CellCept 500 mg powder for concentrate for solution for infusion
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 CellCept is and what it is used for
2. What you need to know before you have CellCept
3. How you have CellCept
4. Possible side effects
5. How to store CellCept 6. Contents of the pack and other information
7. Making up the medicine
1. What CellCept is and what it is used for
The full name of your medicine is CellCept 500 mg powder for concentrate for solution for infusion.
CellCept contains mycophenolate mofetil.
CellCept is used to prevent your body rejecting a transplanted organ.
CellCept should be used together with other medicines:
2. What you need to know before you take CellCept
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.
Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Do not take CellCept:
Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before having CellCept.
Warnings and precautions
Talk to your doctor or nurse straight away before having CellCept:
If any of the above apply to you (or you are not sure), talk to your doctor or nurse straight away before having CellCept.
The effect of sunlight
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
Other medicines and CellCept
Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because CellCept can affect the way some other medicines work. Also other medicines can affect the way CellCept works.
In particular, tell your doctor or nurse if you are taking any of the following medicines before you start CellCept:
If you need to have a vaccine (a live vaccine) while having CellCept, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
Pregnancy, contraception and breast-feeding
Contraception in women taking CellCept
If you are a woman who could become pregnant you must always use two effective methods of contraception with CellCept. This includes:
Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.
You are a woman who is not capable of becoming pregnant if any of the following applies to you:
Contraception in men taking CellCept
You must always use condoms during treatment and for 90 days after you stop taking CellCept.
If you are planning to have a child, your doctor will talk to you about the risks and the alternative treatments you can take to prevent rejection of your transplant organ.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking CellCept until you see him or her.
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-27 %) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.
If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.
Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.
Driving and using machines
CellCept is not likely to affect you being able to drive or use any tools or machines.
3. How to take CellCept
Cellcept is usually given by a doctor or nurse in hospital. It is given as a slow drip (infusion) into a vein.
How much to take
The amount you take depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.
Making up the medicine
The medicine comes as a powder. This needs mixing with glucose before using. Your doctor or nurse will make up the medicine and give it to you. They will follow the instructions under Section 7 “Making up the medicine”.
If you have more CellCept than you should
If you think that you have had too much medicine, talk to your doctor or nurse straight away.
If you forget to take CellCept
If a dose of CellCept is missed, this will be given to you as soon as possible. Your treatment will then continue at the normal times.
If you stop taking CellCept
Do not stop having CellCept unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, CellCept can cause side effects, although not everybody gets them.
Talk to a doctor or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
Lymph and skin cancer
As can happen in patients having this type of medicine (immune-suppressants), a very small number of CellCept patients have developed cancer of the lymphoid tissues and skin.
General unwanted effects
You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle, pain on passing urine), headache, flu symptoms and swelling.
Other unwanted effects may include:
Skin problems such as:
Urinary problems such as:
Digestive system and mouth problems such as:
Nervous system problems such as:
Heart and blood vessel problems such as:
Lung problems such as:
Other problems such as:
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).
5. How to store CellCept
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What CellCept contains
What CellCept looks like and contents of the pack
7. MAKING UP THE MEDICINE
Method and route of administration
CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
The contents of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 mL of glucose intravenous infusion 5% each. A further dilution with glucose intravenous infusion 5% is required to a final concentration of 6 mg/mL. This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 mL) must be further diluted into 140 mL glucose intravenous infusion 5% solution. If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.
Take care not to let the made-up medicine get into your eyes.
Take care not to let the made-up medicine get on your skin.
CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) infusion. The infusion flow rate should be controlled to equate to a 2 hour period of administration.
CellCept IV solution should never be administered by rapid or bolus intravenous injection.
Marketing Authorisation Holder
Manufacturing Authorisation holder responsible for batch release:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in November 2015
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
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