CELLCEPT 500 MG FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

CellCept500mg film-coated tablets

mycophenolate mofetil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is CellCept and what is it used for

CellCept contains mycophenolate mofetil:

• It belongs to a group of medicines called “immunosuppressants”.

CellCept is used to prevent your body from rejecting a transplanted organ in adults and children:

• Kidney, heart or liver.

CellCept must be used together with other medicines:

• Ciclosporin and corticosteroids.

2. What you need to know before you take CellCept

WARNING

Mycophenolate causes birth defects and miscarriages. If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the advice on contraception given by your doctor.

Your doctor will explain 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 understand these instructions completely, please consult your doctor again so that they can explain them to you once more before you take mycophenolate. See more information below in this section, under the headings “Warnings and precautions” and “Pregnancy and breast-feeding”.

Do not take CellCept:

• If you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman who can become pregnant and have not had a negative pregnancy test before your first prescription, since mycophenolate can cause birth defects and miscarriages.
• If you are pregnant or plan to become pregnant or think you may be pregnant.
• If you are not using effective contraception (see Contraception, pregnancy and breast-feeding).
• If you are breast-feeding.

Do not take this medicine if any of the above apply to you. If you are not sure, consult your doctor or pharmacist before taking CellCept.

Warnings and precautions

Consult your doctor before starting treatment with CellCept:

• If you are over 65 years old, as you may have a higher risk of developing side effects such as certain viral infections, gastrointestinal bleeding and pulmonary oedema compared to younger patients.
• If you have any signs of infection such as fever or sore throat.
• If you have unexpected bruising or bleeding.
• If you have ever had a problem with your digestive system, such as a stomach ulcer.
• If you plan to become pregnant or have become pregnant while you or your partner are taking CellCept.
• If you have a hereditary enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If any of the above apply to you (or you are not sure), consult your doctor immediately before starting treatment with CellCept.

Effect of sunlight

CellCept reduces your body's defences. For this reason, there is a higher risk of skin cancer. Limit the amount of sunlight and UV light you absorb by:

• wearing protective clothing, including a hat, and covering your arms and legs.
• using a sunscreen with a high protective factor.

Children

Children, especially those under 6 years of age, are more likely than adults to have certain side effects, including diarrhoea, vomiting, infections, low red blood cell count and low white blood cell count, and the possibility of lymphoma or skin cancer.

The tablets are only suitable for children who can swallow tablets whole without risk of choking. Therefore, the medicine should only be given according to the doctor's prescription.

If you are not sure about anything related to your child's treatment, talk to your doctor or pharmacist before taking it.

Other medicines and CellCept

Tell your doctor or pharmacist 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 may affect the way other medicines work. Also, other medicines may affect the way CellCept works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before starting CellCept:

• azathioprine or another medicine that suppresses the immune system – which was given to you after your transplant operation.
• cholestyramine – used to treat high cholesterol levels.
• rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB).
• antacids, or proton pump inhibitors – used for stomach acid problems such as indigestion.
• phosphate binders – used in patients with chronic kidney failure to reduce phosphate absorption into the blood.
• antibiotics – used to treat bacterial infections.
• isavuconazole – used to treat fungal infections.
• telmisartan – used to treat high blood pressure.

Vaccines

If you need to have a vaccine (live organism vaccine) during treatment with CellCept, consult your doctor or pharmacist first. Your doctor will advise you on the vaccines you can have.

Do not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men should not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.

Taking CellCept with food and drink

Taking food and drink has no effect on your treatment with CellCept.

Contraception in women taking CellCept

If you are a woman who can become pregnant, you must use a reliable method of contraception. This includes:

• Before you start taking CellCept.
• During the entire treatment with CellCept.
• Until 6 weeks after stopping CellCept.

Consult your doctor to determine the most suitable contraceptive method for you. This will depend on your personal situation. It is recommended to use two contraceptive methods as this will reduce the risk of unintended pregnancy. Consult your doctor as soon as possible if you think your contraceptive method may not have been effective or if you have forgotten to take your contraceptive pill.

You cannot become pregnant if:

• You are post-menopausal, i.e. you are over 50 years old and your last period was more than a year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant).
• Your fallopian tubes and both ovaries have been surgically removed (bilateral salpingo-oophorectomy).
• Your uterus has been surgically removed (hysterectomy).
• Your ovaries do not work (premature ovarian failure confirmed by a specialist gynaecologist).
• You were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome or uterine agenesis.
• You are a girl or adolescent who has not started having periods.

Contraception in men taking CellCept

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precaution, it is recommended that you or your female partner use a reliable method of contraception during treatment and for 90 days after stopping CellCept.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss the risks and alternative treatments that you can take to prevent organ rejection if:

• You plan to become pregnant.
• You have missed a period or have unusual menstrual bleeding or suspect you may be pregnant.
• You have had unprotected sex.

If you become pregnant during treatment with mycophenolate, inform your doctor immediately. However, continue taking CellCept until you see your doctor.

Pregnancy

Mycophenolate causes a very high frequency of miscarriages (50%) and severe harm to the unborn baby (23-27%). Among the birth defects reported are ear, eye, facial (cleft lip and palate), finger, heart, oesophagus (tube connecting the throat to the stomach), kidney and nervous system defects (e.g. spina bifida, where the bones of the spine do not develop properly). Your baby may be affected by one or more of these.

If you are a woman who can become pregnant, you must have a negative pregnancy test before starting treatment and must follow the advice on contraception given by your doctor. Your doctor may request more than one pregnancy 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 may pass into breast milk.

Driving and using machines

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

CellCept contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take CellCept

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, consult your doctor or pharmacist.

How much to take

The amount to take depends on the type of transplant you have. The usual doses are shown below. Treatment will continue until it is necessary to prevent organ rejection.

Kidney transplant

Adults

• The first dose must be given within 3 days after the transplant operation.
• The daily dose is 4 tablets (2 g of the medicine), taken in 2 separate doses.
• This means taking 2 tablets in the morning and 2 tablets in the evening.

Children

• The tablets are only suitable for children who can swallow tablets whole without risk of choking. Therefore, the medicine should only be given according to the doctor's prescription. If you are not sure, talk to your doctor or pharmacist before taking it.
• The dose varies depending on the child's size.
• Your child's doctor will decide the most suitable dose based on the child's height and weight (body surface area measured in square metres “m2”). The recommended starting dose is 600 mg/m2, taken twice a day. The dose should be individualised based on the doctor's clinical evaluation. The dose can be increased to a maximum of 2 g per day (given in 2 separate doses).

Heart transplant

Adults

• The first dose must be given within 5 days after the transplant operation.
• The daily dose is 6 tablets (3 g of the medicine), taken in 2 separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• The tablets are only suitable for children who can swallow tablets whole without risk of choking. Therefore, the medicine should only be given according to the doctor's prescription. If you are not sure, talk to your doctor or pharmacist before taking it.
• The dose varies depending on the child's size.
• Your child's doctor will decide the most suitable dose based on the child's height and weight (body surface area measured in square metres “m2”). The recommended starting dose is 600 mg/m2, taken twice a day. The dose should be individualised based on the doctor's clinical evaluation. If well tolerated, the dose can be increased to 900 mg/m2 twice a day if necessary (maximum total daily dose of 3 g).

Liver transplant

Adults

• The first dose should be given at least 4 days after the transplant operation and when you are able to take oral medication.
• The daily dose is 6 tablets (3 g of the medicine), taken in 2 separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• The tablets are only suitable for children who can swallow tablets whole without risk of choking. Therefore, the medicine should only be given according to the doctor's prescription. If you are not sure, talk to your doctor or pharmacist before taking it.
• The dose varies depending on the child's size.
• Your child's doctor will decide the most suitable dose based on the child's height and weight (body surface area measured in square metres “m2”). The recommended starting dose is 600 mg/m2, taken twice a day. The dose should be individualised based on the doctor's clinical evaluation. If well tolerated, the dose can be increased to 900 mg/m2 twice a day if necessary (maximum total daily dose of 3 g).

Taking this medicine

• Swallow the tablets whole with a glass of water.
• Do not break or crush them.

If you take more CellCept than you should

If you take more CellCept than you should, consult your doctor or go to the hospital immediately. Do this even if someone accidentally takes your medicine. Take the medicine pack with you.

If you forget to take CellCept

If you forget to take a dose, 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 dose.

If you stop taking CellCept

Do not stop taking CellCept unless your doctor tells you to. If you stop treatment, you may increase the risk of organ rejection.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Consult your doctor immediately if you notice any of the following serious adverse effects, as you may need urgent medical treatment:

Common Problems

Some of the most common problems are diarrhea, decrease in the number of white or red blood cells in the blood, infection, and vomiting. Your doctor will perform regular blood tests to monitor any changes in:

• the number of blood cells or signs of infection

Fighting Infections

Treatment with CellCept reduces the body's defenses. This is to prevent transplant rejection. For this reason, the body cannot fight infections as effectively as under normal conditions. This means you may contract more infections than usual. These include infections that affect the brain, skin, mouth, stomach, and intestines, lungs, and urinary system.

Skin and Lymph Cancer

As with patients taking this type of medicine (immunosuppressants), a very small number of patients treated with CellCept have developed cancer of lymphoid tissues and skin.

General Undesired Effects

General adverse effects may occur that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very tired, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, swelling.

Other adverse effects may be:

Skin Problemssuch as:

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

Urinary Problemssuch as:

• blood in the urine.

Problems with the Digestive System and Mouthsuch as:

• swollen gums and mouth ulcers,
• inflammation of the pancreas, colon, or stomach,
• gastrointestinal disorders that include bleeding,
• liver disorders,
• diarrhea, constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence.

Nervous System Problemssuch as:

• feeling dizzy, drowsy, or numb,
• tremors, muscle spasms, seizures,
• feeling anxious or depressed, changes in mood or thinking.

Cardiac and Blood Vessel Problemssuch as:

• changes in blood pressure, rapid heartbeat, and dilation of blood vessels.

Lung Problemssuch as:

• pneumonia, bronchitis,
• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Consult your doctor if you develop a persistent cough or shortness of breath,
• fluid in the lungs or inside the chest,
• problems with the sinuses.

Other Problemssuch as:

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

Additional Adverse Reactions in Children and Adolescents

Children, especially those under 6 years of age, are more likely than adults to have some adverse reactions, including diarrhea, vomiting, infections, fewer red and white blood cells in the blood, and the possibility of lymphoma or skin cancer.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of CellCept

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging after EXP.
• Do not store above 30 °C.
• Keep in the original packaging to protect it from moisture.
• Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of CellCept Film-Coated Tablets

• The active ingredient is mycophenolate mofetil.
• Each tablet contains 500 mg of mycophenolate mofetil.
• The other ingredients are:
• CellCept tablets: microcrystalline cellulose, povidone (K-90), sodium croscarmellose, magnesium stearate (see section 2 "CellCept contains sodium").
• Tablet coating: hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), polyethylene glycol 400, carmine indigo lake (E132), red iron oxide (E172).

Appearance of the Product and Package Contents

• CellCept tablets are oblong, pale blue. They have "CellCept 500" engraved on one side and "Roche" on the other.
• They are available in packs of 50 tablets (in blisters of 10) or in multiple packs of 150 tablets (3 packs of 50). Only some pack sizes may be marketed.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu