Prospecto:information for the patient

CellCept500mg film-coated tablets

micofenolato mofetilo

Read this prospectus carefully before starting to take this medicine, because it contains important information for you.

•Keep this prospectus, as you may need to read it again.

•If you have any doubts, consult your doctor or pharmacist.

•This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

•If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is CellCept and what it is used for

2.What you need to know before starting to take CellCept

3.How to take CellCept

4.Possible adverse effects

5.Storage of CellCept

6.Contents of the package and additional information

CellCept contains mycophenolate mofetil:

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

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

•Kidney, heart or liver.

CellCept must be used in combination with other medicines:

•Ciclosporin andcorticosteroids.

WARNING

Mycophenolate causes congenital malformations and spontaneous abortions. If you are a woman who can become pregnant, you must have a negative pregnancy test result before starting treatment and follow the contraceptive advice provided by your doctor.

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

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

Do not take CellCept:

•If you are allergic to mycophenolate mofetil, mycophenolic acid, or any of the other components of this medication (including those listed in section 6).

•If you are a woman who can become pregnant and have not obtained a negative pregnancy test result before the first prescription, as mycophenolate may cause congenital malformations and spontaneous abortions.

•If you are pregnant or intend to become pregnant or believe you may be pregnant.

•If you are not using effective contraceptives (see Contraception, Pregnancy, and Breastfeeding).

•If you are breastfeeding.

Do not take this medication if you experience any of the above. If you are unsure, 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 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 experience unexpected cardinals or bleeding.

•If you have had any digestive system problems, such as stomach ulcers.

•If you plan to become pregnant or have become pregnant while taking CellCept.

•If you have an inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

If you experience any of the above (or are unsure), consult your doctor immediately before starting treatment with CellCept.

Effect of sunlight

CellCept reduces your body's defenses. As a result, there is a higher risk of developing skin cancer. Limit the amount of sunlight and UV light you absorb by:

•Wearing appropriate clothing that protects you and also covers your head, neck, arms, and legs.

•Using a high-protection sunscreen cream.

Children

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

Only tablets are suitable for children who can swallow solid medication without risk of asphyxiation. Therefore, the medication should only be given according to the doctor's prescription.

If you are unsure about anything related to your child's treatment, speak with your doctor or pharmacist before taking it.

Other medications and CellCept

Inform your doctor or pharmacist if you are using or have recently used any other medication. This includes over-the-counter medications, such as herbal remedies. This is because CellCept may affect how other medications work. Other medications may also affect how CellCept works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications before starting CellCept:

•Azathioprine or another immunosuppressive medication – administered after transplant surgery.

•Colestiramine – 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 disease 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 on the vaccines that can be administered.

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

CellCept with food and drinks

The consumption of food and drinks 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 an effective contraceptive method. This includes:

•Before starting to take CellCept.

•During the entire treatment with CellCept.

•Until 6 weeks after stopping CellCept.

Consult your doctor to see which contraceptive method is most suitable for you. This will depend on your individual 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 believe your contraceptive method may not have been effective or if you have forgotten to take the contraceptive pill.

You cannot become pregnant if your case is one of the following:

•You are postmenopausal, i.e., you are at least 50 years old and your last period occurred more than a year ago (if your periods have stopped due to cancer treatment, there is still a possibility that you may become pregnant).

•Your fallopian tubes and ovaries have been surgically removed (bilateral salpingo-oophorectomy).

•Your uterus has been 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 diseases that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis.

•You are a girl or adolescent who has not started menstruating.

Contraception in men taking CellCept

The available evidence does not indicate a higher risk of malformations or spontaneous abortion if the father takes mycophenolate. However, the risk cannot be completely ruled out. As a precaution, it is recommended that you or your female partner use a reliable contraceptive method 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 breastfeeding

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will discuss the risks and alternative treatments you can take to prevent organ transplant rejection if:

•You intend to become pregnant.

•You have missed or suspect you may 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 spontaneous abortions (50%) and severe damage to the unborn baby (23-27%). Among the malformations reported are ear, eye, facial (cleft lip and palate), finger development, heart, esophagus (tube connecting the throat to the stomach), kidney, and nervous system (e.g., spina bifida) abnormalities. 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 result before starting treatment and follow the contraceptive advice provided by your doctor. Your doctor may request multiple pregnancy tests to ensure you are not pregnant before starting treatment.

Breastfeeding

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

Driving and using machines

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

CellCept contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Amount 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 rejection of the transplanted organ.

Kidney transplant

Adults

•The first dose must be administered within 3 days after the transplant surgery.

•The daily dose is 4 tablets (2g of the medication), administered in 2 separate doses.

•This means taking 2 tablets in the morning and other 2 tablets at night.

Children

•Tablets are only suitable for children who can swallow solid medication without risk of asphyxiation. Therefore, the medication should only be given according to the doctor's prescription. If unsure, speak with your doctor or pharmacist before taking it.

• The dose varies depending on the child's height.

•Your child's doctor will decide on the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2”). The recommended starting dose is 600mg/m2, administered twice a day. The recommended maintenance dose is maintained at 600 mg/m2twice a day (maximum total daily dose of 2 g). The dose should be individualized based on clinical evaluation by the doctor.

Heart transplant

Adults

•The first dose must be administered within 5 days after the transplant surgery.

•The daily dose is 6 tablets (3g of the medication), administered in 2 separate doses.

•Take 3 tablets in the morning and other 3 tablets at night.

Children

• Tablets are only suitable for children who can swallow solid medication without risk of asphyxiation. Therefore, the medication should only be given according to the doctor's prescription. If unsure, speak with your doctor or pharmacist before taking it.
• The dose varies depending on the child's height.
• Your child's doctor will decide on the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2”). The recommended starting dose is 600mg/m2, administered twice a day. The dose should be individualized based on clinical evaluation by the doctor. If well tolerated, the dose can be increased to 900mg/m2twice a day if necessary (maximum total daily dose of 3g).

Liver transplant

Adults

•The first dose should be administered at least 4 days after the transplant surgery and when able to swallow oral medication.

•The daily dose is 6 tablets (3g of the medication), administered in 2 separate doses.

•Take 3 tablets in the morning and other 3 tablets at night.

Children

• Tablets are only suitable for children who can swallow solid medication without risk of asphyxiation. Therefore, the medication should only be given according to the doctor's prescription. If unsure, speak with your doctor or pharmacist before taking it.
• The dose varies depending on the child's height.
• Your child's doctor will decide on the most suitable dose taking into account the child's height and weight (body surface area measured in square meters "m2”). The recommended starting dose is 600mg/m2, administered twice a day. The dose should be individualized based on clinical evaluation by the doctor. If well tolerated, the dose can be increased to 900mg/m2twice a day if necessary (maximum total daily dose of 3g).

Taking this medication

•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 also if someone accidentally takes your medication. Bring the medication packaging with you.

If you forget to take CellCept

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

If you interrupt the CellCept treatment

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

•if you have symptoms of infection such as fever or sore throat

•if you develop rashes or unexpected bleeding

•if you have a rash, facial swelling, lip, tongue, or throat swelling with difficulty breathing. You may be having a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems

Some of the most common problems are diarrhea, decreased white blood cell or red blood cell count 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

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

Skin and lymphatic cancer

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

Unwanted general effects

You may experience general unwanted effects that affect your entire body. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling extremely tired, difficulty sleeping, pains (such as stomach pain, chest pain, joint or muscle pain), headache, flu-like symptoms, swelling.

Other side effects may be:

Skin problemssuch as:

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

Urinary problemssuch as:

•blood in the urine.

Digestive system and mouth problemssuch as:

•swollen gums and mouth ulcers,

•pancreatitis, colon, or stomach inflammation,

•gastrointestinal disorders that include bleeding,

•liver disorders,

•diarrhea,constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence.

Nervous system problemssuch as:

•dizziness, drowsiness, or numbness,

•shaking, muscle spasms, convulsions,

•feeling anxious or depressed, mood or thought changes.

Cardiovascular and vascular problemssuch as:

•changes in blood pressure, rapid heartbeat, and blood vessel dilation.

Pulmonary 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 (lung scarring). Consult your doctor if you develop persistent cough or shortness of breath,

•fluid in the lungs or chest cavity,

•nasal sinus problems.

Other problemssuch as:

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

Additional adverse reactions in children and adolescents

Children, especially those under 6 years of age, are more prone to some adverse reactions, including diarrhea, vomiting, infections, decreased white blood cell or red blood cell count in the blood, and possibility of lymphoma or skin cancer.

Reporting adverse effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

•Keep this medication out of the sight and reach of children.

•Do not use this medication after the expiration date that appears on the packaging after EXP.

•Do not store at a temperature above 86°F.

•Store in the original packaging to protect it from moisture.

•Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of CellCept film-coated tablets

•The active ingredient is mycophenolate mofetil.

•Each tablet contains 500 mg of mycophenolate mofetil.

•The other components are:

•CellCept tablets: microcrystalline cellulose, povidone (K-90), croscarmellose sodium, magnesium stearate (see section 2 “CellCept contains sodium”).

•Coating of the tablets: hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), polyethylene glycol 400, indigo carmine in aluminium lake (E132), iron oxide red (E172).

Appearance of the product and contents of the pack

•CellCept tablets are oblong, blue forget-me-not in color. They have the imprint "CellCept 500" on one side and “Roche” on the other.

•They are available in packs of 50 tablets (in a blister pack of 10) or in multiple packs of 150 tablets (3 packs of 50). They may only be marketed in some pack sizes.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Responsible Person

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:

Last update of this leaflet

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu