CellCept® 250 mg Capsules

CellCept is used to prevent your body rejecting a transplanted kidney, heart or liver. CellCept is used together with other medicines.

Do not take CellCept:

• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of CellCept.
• If you are pregnant or breastfeeding.
• If you have Lesch - Nyhan or Kelley - Seegmiller syndrome or another rare inherited deficiency hypoxanthine - guanine phosphoribosyl - transferase (HGPRT). You should not take CellCept if you have one of these disorders.
• If you have phenylketonuria (PKU). CellCept oral suspension contains aspartame (a source of phenylalanine).

Take special care with CellCept: You should inform your doctor immediately:

• If you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
• If you have or have ever had any problems with your digestive system, e.g., stomach ulcers.
• If you are planning to become pregnant or if you become pregnant while taking CellCept. CellCept reduces your body’s defence mechanisms. Because of this, there is an increased risk of cancer including 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.

Do not share medicines prescribed for you with another person. Always take CellCept exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Method and route of administration

Swallow your capsules/tablets 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 your body rejecting your transplanted organ. Your doctor will tell you how long your treatment with CellCept will last. Do not stop treatment early. If you have the impression that the effect of CellCept is too strong or too weak for you, tell your doctor or pharmacist.

If you take more CellCept than you should: If you take more CellCept 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. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

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. Do not take a double dose to make up for a forgotten individual dose.

If you stop taking CellCept: 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. If you have any further questions on the use of CellCept, ask your doctor.

CellCept can have side effects. Not all side effects reported for CellCept are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CellCept, please consult your doctor, pharmacist or other healthcare professional for advice.

Frequent: 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 body’s own defence mechanisms to stop rejection of 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 brain, skin, mouth, stomach and intestines, lungs and urinary tract.

Less frequent: A small number of CellCept patients have developed cancer of the lymph tissues and skin. General side effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioedema, 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 notice any side effects not listed in this leaflet please inform your doctor or pharmacist. If you are concerned about these or any other unexpected effect(s), talk to your doctor. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. CellCept 250 mg capsules and CellCept 500 mg tablets: Store at or below 25 ºC. CellCept OS powder for oral suspension: Store at or below 30 ºC. The shelf life of the constituted suspension is 60 days when stored below 30 C. Any unused suspension must be discarded after 60 days. Keep the container tightly closed.

Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed. Avoid inhalation, or direct contact with skin or mucous membranes, of the powder contained in CellCept capsules. If such contact occurs, wash thoroughly with soap and water, rinse eyes with plain water. Do not use CellCept after the expiry date that has been printed on the container. Reconstituted solution Store at 15 – 30 C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).