CellCept® (Mycophenolate Mofetil)

What is it?

CellCept capsules are used to prevent your body rejecting a transplanted kidney, heart or liver. CellCept is used together with other drugs known as cyclosporine and corticosteroids.

How to use it? 

Do not take CellCept: If you are hypersensitive (allergic) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of CellCept.
Take special care with CellCept:

• If the answer to any of the following questions is yes, talk to your doctor before you start to take CellCept:
  • Do you now have, or have you ever had, any problems with your digestive system, e.g., stomach ulcers?
  • Are you taking any medicines containing: azathioprine or other immunosuppressive agents (which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), antacids, or any other drugs (including those you can buy without a prescription) that your doctor does not know about?
  • Do you need to receive vaccines (live vaccines)? Your doctor will have to advise you what is indicated for you.
• In case of any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding you should inform your doctor immediately.
• Cellcept reduces your body's defence mechanism. Because of this, there is an increased risk of skin cancer. Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.

Pregnancy and breast-feeding:

Your doctor should advise you about using contraception before taking CellCept, whilst takingCellCept, and for 6 weeks after you have stopped taking CellCept. This is because CellCept may cause damage to your unborn baby. Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.

Driving and using machines:

CellCept has not been shown to impair your ability to drive or operate machinery.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

How to take it?

You must take your capsules or your tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual way to take CellCept is as follows:

• Kidney Transplant Adults:
  The first does will be given within 72 hours after the transplant operation. The recommended daily dost is 8 capsules or 4 tablets (2g of active ingredient)taken as 2 separate doses. This means taking 4capsules or 2 tablets in the morning then 4 capsules or 2 tablets in the evening. Children (aged 1 to 18 years): The dose given will vary depending on the size of the child. Your doctor will decide the most appropriate dose based on body surface area (height and weight). The recommended dose is 600mg/m2 taken twice a day.
  
• Heart Transplant Adults:
  The first dose will be given within 5 days following the transplant operation. The recommended daily dose is 12 capsules (3g of the active ingredient) or 6 tablets taken as 2 separate doses. This means taking 6 capsules or 3 tablets in the morning then 6 capsules or 3 tablets in the evening. Children: No data are available to recommend the use of CellCept in children who have received a heart transplant.
  

• Liver Transplant Adults:
  The first does of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications. The recommended daily dose is 12 capsules or 6 tablets (3g of the active ingredient) taken as 2 separate doses. This means taking 6 capsules or 3 tablets in the morning then 6 capsules or 3 tablets in the evening. Children: No data are available to recommend the use of CellCept in children who have received a liver transplant.

Method and route of administration:

Swallow your capsules whole with a glass of water. Do not break or crush them and do not take any capsules that have broken open or split. Avoid contact with any powder that spills out from damaged capsules. If a capsule breaks open accidentally, wash any powder from your skin with soap and water. If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water. Treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplanted organ.

If you take more CellCept than you should:

If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.

If you forget to take CellCept:

If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times.

Effects when treatment with CellCept is stopped:Stopping your treatment with CellCept may increase the chance of rejection of your transplanted organ. Do not stop taking your medicine unless your doctor tells you to.

What are the side effects?

Like all medicines, CellCept can have side effects, even when used as directed. Some of the more usual problems are diarrhoea, fewer white cells and/or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to monitor any changes in the number of your blood cells or changes in the levels of any of the substances carried in your blood, e.g. sugar, fat, cholesterol.Children may be more likely than adults to have side effects such as diarrhoea, infections, fewer white cells and fewer red cells in the blood. CellCept reduces your bodys own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver. Consequently your body will not be as good as normal at fighting infections. So if you are taking CellCept you may therefore catch more infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract. As can happen in-patients taking this type of medicine, a very small number of CellCept patients have developed cancer of the lymphoid tissues and skin. General unwanted effects affecting your body as a whole could include fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/muscle, pain on passing urine), headache, flu symptoms and swelling.

Other unwanted effects may include: Disorders of the skin such as acne, cold sores, shingles, skin growth, hair loss, rash, itching. Urinary disorders such as kidney problems or the urgent need to pass urine. Disorders of the digestive system and mouth such as constipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence and mouth ulcers. Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood. Metabolic, blood and vascular disorders such as weight loss, gout, high blood sugar, bleeding, clots and bruises, change in blood pressure, abnormal heart beat and dilation of blood vessels may be seen. Disorders of the lungs such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/chest cavity, sinus problems. If you do have any side effects, or if you notice any other problems not mentioned in this leaflet whilst you are taking CellCept, please inform your doctor or pharmacist. However, do not stop taking your medicine unless you have discussed this with your doctor first.

Storing it

• Keep out of the reach and sight of children. Do not store above 30C.
  
• Do not use the capsules after the expiry date, which is printed on the carton.
  
• Any unused product or waste material should be disposed of in accordance with local requirements.

Further information 

For more information about this medicinal product, please contact your doctor or pharmacist