CellCept 500 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

CellCept 500 mg film-coated tablets

mycophenolate mofetil

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What CellCept is and what it is used for

CellCept contains mycophenolate mofetil:

• It belongs to a group of medicines called "immunosuppressants".

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

• Kidney, heart, or liver.

CellCept should be used in combination with other medicines:

• Cyclosporine and corticosteroids.

2. What you need to know before starting CellCept

WARNING

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

Your doctor will explain and provide you with written information, particularly about the effects of mycophenolate on unborn babies. Read this information carefully and follow the instructions.

If you do not fully understand these instructions, please consult your doctor again for further explanation before taking mycophenolate. See more information below in this section under the headings “Warnings and precautions”, “Contraception”, and “Pregnancy and breastfeeding”.

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 could become pregnant and have not had a negative pregnancy test result before the first prescription, as mycophenolate may cause birth defects and miscarriages.
• If you are pregnant, planning to become pregnant, or think you might be pregnant.
• If you are not using effective contraception (see Contraception, Pregnancy and breastfeeding).
• If you are breastfeeding.

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

Warnings and precautions

Talk to your doctor before starting treatment with CellCept:

• If you are over 65 years old, as you may have a higher risk of developing adverse reactions such as certain viral infections, gastrointestinal bleeding, and pulmonary edema compared to younger patients.
• If you have any signs of infection, such as fever or sore throat.
• If you develop unexpected bruising or bleeding.
• If you have ever had a gastrointestinal disorder, such as a stomach ulcer.
• If you are planning to become pregnant or 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 if you are unsure), consult your doctor immediately before starting treatment with CellCept.

Effect of sunlight

CellCept reduces your body's defenses. For this reason, there is an increased risk of developing skin cancer. Limit your exposure to sunlight and UV light by:

• Wearing appropriate protective clothing that covers your head, neck, arms, and legs.
• Using a sunscreen with a high protection factor.

Children

Children, especially those under 6 years of age, are more likely than adults to experience certain adverse reactions, including diarrhea, vomiting, infections, low red blood cell count, low white blood cell count, and an increased risk of lymphoma or skin cancer.

The tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor.

If you are unsure about anything related to your child’s treatment, speak with your doctor or pharmacist before administering the medicine.

Other medicines and CellCept

Inform 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 remedies. This is because CellCept may affect how other medicines work, and other medicines may affect how CellCept works.

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

• Azathioprine or other immunosuppressive medicines – given after transplant surgery.
• 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 renal failure to reduce phosphate absorption in 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 receive a vaccine (live organism vaccine) during treatment with CellCept, consult your doctor or pharmacist first. Your doctor will advise you on which vaccines are safe for you.

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.

Taking CellCept with food and drinks

Food and drink do not affect your treatment with CellCept.

Contraception in women taking CellCept

If you are a woman who could become pregnant, you must use an effective method of contraception:

• Before starting CellCept.
• Throughout treatment with CellCept.
• For at least 6 weeks after stopping CellCept.

Consult your doctor to determine the most appropriate contraceptive method for you, which will depend on your personal circumstances. The use of two contraceptive methods is recommended, as this reduces the risk of unintended pregnancy. Contact your doctor as soon as possible if you think your contraceptive method may not have been effective or if you missed taking your contraceptive pill.

You cannot become pregnant if any of the following apply to you:

• You are post-menopausal, i.e., you are at least 50 years old and your last menstrual period occurred more than one year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant).
• You have had both fallopian tubes and both ovaries surgically removed (bilateral salpingo-oophorectomy).
• You have had your uterus surgically removed (hysterectomy).
• Your ovaries do not function (premature ovarian failure confirmed by a specialist gynecologist).
• 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 yet started menstruating.

Contraception in men taking CellCept

Available evidence does not indicate an increased risk of birth defects or miscarriage when the father takes mycophenolate. However, a risk cannot be completely ruled out. As a precaution, you or your female partner are advised to use a reliable method of contraception during treatment and for 90 days after stopping CellCept.

If you are planning to have a child, discuss potential risks and alternative treatments with your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will discuss the risks and alternative treatments available to prevent rejection of the transplanted organ if:

• You plan to become pregnant.
• You miss a period or think you may have missed a period, have unusual menstrual bleeding, or suspect you might be pregnant.
• You have had sexual intercourse without using effective contraception.

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 rate of miscarriage (50%) and serious harm to the unborn baby (23–27%). Reported birth defects include abnormalities of the ears, eyes, face (cleft lip and palate), fingers, heart, esophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g., spina bifida, where the spinal bones do not develop properly). Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment and must follow your doctor’s contraception advice. Your doctor may require more than one pregnancy test to confirm you are not pregnant before starting treatment.

Breastfeeding

Do not take CellCept if you are breastfeeding. This is because small amounts of the medicine may pass into breast milk.

Driving and using machines

The effect of CellCept on the ability to drive and operate machinery is moderate. If you feel drowsy, dizzy, or confused, speak with your doctor or nurse and do not drive or operate tools or machinery until you feel better.

CellCept contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take CellCept

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Dosage

The dose you need depends on the type of transplant you have received. The usual doses are shown below. Treatment will continue for as long as necessary to prevent rejection of the transplanted organ.

Kidney transplant

Adults

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

Children

• Tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor. If you are unsure, speak with your doctor or pharmacist before administering.
• The dose varies depending on the child's size.
• Your child's doctor will decide the most appropriate dose based on the child's height and weight (body surface area measured in square meters “m2”). The recommended starting dose is 600 mg/m2, administered twice daily. The recommended maintenance dose remains at 600 mg/m2 twice daily (maximum total daily dose of 2 g). Dosing should be individualized based on clinical assessment by the physician.

Heart transplant

Adults

• The first dose should be administered within 5 days after the transplant surgery.
• The daily dose is 6 tablets (3 g of the medicine), given in two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• Tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor. If you are unsure, speak with your doctor or pharmacist before administering.
• The dose varies depending on the child's size.
• Your child's doctor will decide the most appropriate dose based on the child's height and weight (body surface area measured in square meters “m2”). The recommended starting dose is 600 mg/m2, administered twice daily. Dosing should be individualized based on clinical assessment by the physician. If well tolerated, the dose may be increased to 900 mg/m2 twice daily if necessary (maximum total daily dose of 3 g).

Liver transplant

Adults

• The first dose should be administered at least 4 days after transplant surgery and once the patient is able to swallow oral medication.
• The daily dose is 6 tablets (3 g of the medicine), given in two separate doses.
• Take 3 tablets in the morning and 3 tablets in the evening.

Children

• Tablets are only suitable for children who can swallow solid medication without risk of choking. Therefore, the medicine should only be given as prescribed by the doctor. If you are unsure, speak with your doctor or pharmacist before administering.
• The dose varies depending on the child's size.
• Your child's doctor will decide the most appropriate dose based on the child's height and weight (body surface area measured in square meters “m2”). The recommended starting dose is 600 mg/m2, administered twice daily. Dosing should be individualized based on clinical assessment by the physician. If well tolerated, the dose may be increased to 900 mg/m2 twice daily if necessary (maximum total daily dose of 3 g).

How to take 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 prescribed, contact your doctor or go to the hospital immediately. Do this even if someone accidentally takes your medicine. Bring the medicine packaging with you.

If you forget to take CellCept

If you forget to take a dose, take it as soon as you remember. Then continue taking it at your usual times. Do not take a double dose to make up for a missed dose.

If you stop taking CellCept

Do not stop taking CellCept unless instructed by your doctor. Stopping treatment may increase the risk of rejection of the transplanted organ.

If you have any further 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 everyone will experience them.

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

• if you have symptoms of infection such as fever or sore throat
• if you develop bruising or unexpected bleeding
• rash, itching, hives, difficulty breathing or shortness of breath, wheezing, cough, dizziness, lightheadedness, changes in level of consciousness, hypotension, with or without mild generalized itching, skin redness, and swelling of the face or throat (symptoms of a severe allergic reaction)

Frequent problems

Some of the more common problems include diarrhea, decreased number of white or red blood cells in the blood, infections, and vomiting. Your doctor will perform regular blood tests to monitor for any changes in:

• blood cell counts or signs of infection

Fighting infections

Treatment with CellCept reduces the body's natural defenses. This is intended to prevent transplant rejection. For this reason, the body is also less able to fight infections as effectively as under normal conditions. This means you may be more prone to infections than usual. These may include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

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

General adverse effects

General adverse effects affecting the whole body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, extreme fatigue, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, and swelling.

Other adverse effects may include:

Skin problems such as:

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

Urinary problems such as:

• blood in the urine.

Digestive system and mouth problems such as:

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

Nervous system problems such as:

• dizziness, drowsiness, or numbness,
• tremor, muscle spasms, seizures,
• feelings of anxiety or depression, changes in mood or thinking.

Heart and blood vessel problems such as:

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

Lung problems such as:

• pneumonia, bronchitis,
• difficulty breathing, cough, which may be due to bronchiectasis (a condition in which the lung airways are abnormally widened) 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 cavity,
• sinus problems.

Other problems such 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 experience certain adverse reactions, including diarrhea, vomiting, infections, lower numbers of red and white blood cells in the blood, and an increased risk of lymphoma or skin cancer.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CellCept

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

6. Contents of the pack and other information

Composition of CellCept film-coated tablets

• The active substance is mycophenolate mofetil.
• Each tablet contains 500 mg of mycophenolate mofetil.
• The other components 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, indigo carmine aluminium lake (E132), iron oxide red (E172).

Description of the product and contents of the pack

• CellCept tablets are oblong, light blue in colour. They are engraved with "CellCept 500" on one side and "Roche" on the other.
• They are available in packs of 50 tablets (in 10-tablet blisters) or in multiple packs of 150 tablets (3 packs of 50). Not all 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.

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

Date of the most recent review of this leaflet

Other sources of information

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