Cellcept 500mg powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What CellCept is and what it is used for
2. What you need to know before you take CellCept
3. How to take CellCept
4. Possible side effects
5. How to store CellCept
6. Contents of the pack and other information
7. Making up the medicine

• If you are allergic to mycophenolate mofetil, mycophenolic acid, polysorbate 80 or any of the other ingredients in this medicine (listed in section 6)
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
• If you are pregnant or planning to become pregnant or think you may be pregnant
• If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
• If you are breast-feeding.

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.

Talk to your doctor or nurse straight away before starting treatment with CellCept:

• If you are older than 65 years as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding and pulmonary oedema when compared to younger patients
• If you have a sign of infection such as a fever or sore throat
• If you have any unexpected bruising or bleeding
• If you have ever had a problem with your digestive system such as a stomach ulcer
• If you are planning to become pregnant or if you get pregnant while you or your partner are taking CellCept.
• If you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome

If any of the above apply to you (or you are not sure), talk to your doctor or nurse straight away before starting treatment with CellCept.

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:

• wearing protective clothing that also covers your head, neck, arms and legs
• using a sunscreen with a high protection factor.

Do not administer this medicine to children because safety and efficacy of infusions to paediatric patients have not been established.

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, such as 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:

• azathioprine or other medicines that suppress your immune system – given after a transplant operation
• cholestyramine – used to treat high cholesterol
• rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
• phosphate binders – used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood.
• antibiotics – used to treat bacterial infections
• isavuconazole – used to treat fungal infections
• telmisartan – used to treat high blood pressure

If you need to have a vaccination (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.

If you are a woman who could become pregnant, you must use an effective method of contraception with CellCept. This includes:

• Before you start taking CellCept
• During your entire treatment with CellCept
• For 6 weeks after you stop taking CellCept.

Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy. 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 cannot become pregnant if any of the following conditions applies to you:

• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)
• Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
• Your womb (uterus) has been removed by surgery (hysterectomy)
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
• You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner’s syndrome or uterine agenesis
• You are a child or teenager who has not started having periods.

The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution, you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.

If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.

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:

• You plan to become pregnant.
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
• You have sex without using effective methods of contraception.

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.

Pregnancy

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.

Breast-feeding

Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.

CellCept has a moderate influence on your ability to drive or use any tools or machines. If you feel drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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 rejection of your transplant organ.

Kidney transplant

Adults

• The first dose is given within 24 hours of the transplant operation.
• The daily dose is 2 g of the medicine taken as 2 separate doses.
• This will be given as 1 g in the morning and then 1 g in the evening.

Liver transplant

Adults

• The first dose is given to you as soon as possible after the transplant operation.
• You will have the medicine for at least 4 days.
• The daily dose is 2 g of the medicine taken as 2 separate doses.
• This will be given as 1 g in the morning and then 1 g in the evening.
• When you are able to swallow, you will be given this medicine by mouth.

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 think that you have had too much medicine, talk to your doctor or nurse straight away.

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.

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.

• you have a sign of infection such as a fever or sore throat
• you have any unexpected bruising or bleeding
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).

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:

• the number of your blood cells or signs of infections.

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.

As can happen in patients having this type of medicine (immune-suppressants), a very small number of patients on CellCept have developed cancer of the lymphoid tissues and skin.

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), headache, flu symptoms and swelling.

Other unwanted effects may include:

Skin problems such as:

• acne, cold sores, skin growth, shingles, hair loss, rash, itching.

Urinary problems such as:

• blood in the urine.

Digestive system and mouth problems such as:

• swelling of the gums and mouth ulcers,
• inflammation of the pancreas, colon or stomach,
• gastrointestinal disorders including bleeding,
• liver disorders,
• diarrhoea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problems such as:

• feeling drowsy or numb,
• tremor, muscle spasms convulsions,
• feeling anxious or depressed, changes in your mood or thoughts.

Heart and blood vessel problems such as:

• change in blood pressure, blood clots, accelerated heartbeat
• pain, redness and swelling of the blood vessels where you had the infusion.

Lung problems such as:

• pneumonia, bronchitis,
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness
• fluid on the lungs or inside the chest,
• sinus problems.

Other problems such as:

• weight loss, gout, high blood sugar, bleeding, bruising.

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). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

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• The active substance is mycophenolate mofetil.
  Each vial contains 500 mg mycophenolate mofetil
• The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride.

• CellCept is provided as white to off-white powder in a 20 ml type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap.
• The reconstituted solution is slightly yellow.
• It is available in packs of 4 vials.

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.

• If this happens, rinse your eyes with plain water.

Take care not to let the made-up medicine get on your skin.

• If this happens, wash the area thoroughly with soap and water.

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.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: