Package leaflet: CellCept 250 mg hard capsules / mycophenolate mofetil

1. What CellCept is and what it is used for

CellCept contains mycophenolate mofetil:
- This belongs to a group of medicines called “immunosuppressants”.
CellCept is used to prevent the body rejecting a transplanted organ in adults and children:
- A kidney, heart or liver.
CellCept should 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 miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.

Your doctor will speak to you 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 fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions” ,“Contraception”, 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 could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
- If you are pregnant or planning 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 applies to you. If you are not sure, talk to your doctor or pharmacist before taking CellCept.

Warnings and precautions
Talk to your doctor straight away before starting treatment with CellCept:
- If you are older than 65 years as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding and pulmonary oedema when compared to younger patients
- If you have a sign of infection such as a fever or sore throat
- If you have any unexpected bruising or bleeding
- If you have ever had a problem with your digestive system such as a stomach ulcer
- If you are planning to become pregnant or if you get pregnant while you or your partner are taking CellCept
- If you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome

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

The effect of sunlight
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
- wearing protective clothing that also covers your head, neck, arms and legs
- using a sunscreen with a high protection factor.

Children
Children, especially those under 6 years old, may be more likely than adults to have some side effects, including diarrhoea, vomiting, infections, fewer red cells and fewer white cells in the blood, and possibly lymph or skin cancer.

Capsules are only appropriate for children who are capable of swallowing solid medicine without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription.

If you are not sure about anything for your child’s treatment, talk to your doctor or pharmacist before use.

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 can affect the way some other medicines work. Also, other medicines can affect the way CellCept works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept:
- azathioprine or other medicines that suppress your immune system – given after a transplant operation
- cholestyramine – used to treat high cholesterol
- rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
- antacids or proton pump inhibitors – used for acid problems in your stomach such as indigestion
- phosphate binders – used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their 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 vaccination (a live vaccine) while taking CellCept, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.

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.

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 could become pregnant, you must use an effective method of contraception with CellCept. This includes:
- Before you start taking CellCept
- During your entire treatment with CellCept
- For 6 weeks after you stop taking CellCept.
Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.

You cannot become pregnant if any of the following conditions applies to you:
- You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)
- Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
- Your womb (uterus) has been removed by surgery (hysterectomy)
- Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
- You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner’s syndrome or uterine agenesis
- You are a child or teenager who has not started having periods.

Contraception in men taking CellCept
The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.

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

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
- You plan to become pregnant.
- You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
- You have sex without using effective methods of contraception.
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking CellCept until you see him or her.

Pregnancy
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23 - 27%) in the unborn baby. Birth defects that have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)). Your baby may be affected by one or more of these.

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

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

CellCept contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take CellCept

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take
The amount you take depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent rejection of your transplant organ.

Kidney transplant
Adults
- The first dose is given within 3 days of the transplant operation.
- The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
- Take 4 capsules in the morning and then 4 capsules in the evening.
Children
- Capsules are only appropriate for children who are capable of swallowing solid medicine without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription. If you are not sure, talk to your doctor or pharmacist before use.
- The dose given will vary depending on the size of the child.
- Your child’s doctor will decide the most appropriate dose based on your child’s height and weight (body surface area – measured as square metres or “m2”). The recommended initial dose is 600 mg/m² taken twice a day. The recommended maintenance dose remains at 600 mg/m2 twice a day (maximum total daily dose of 2 g). The dose should be individualised based on the doctor’s clinical assessment.

Heart transplant
Adults
- The first dose is given within 5 days of the transplant operation.
- The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
- Take 6 capsules in the morning and then 6 capsules in the evening.

Children
- Capsules are only appropriate for children who are capable of swallowing solid medicine without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription. If you are not sure, talk to your doctor or pharmacist before use.
- The dose given will vary depending on the size of the child.
- Your child’s doctor will decide the most appropriate dose based on your child’s height and weight (body surface area – measured as square metres or “m2”). The recommended initial dose is 600 mg/m² taken twice a day. The dose should be individualised based on the doctor’s clinical assessment. If well tolerated, the dose can be increased to 900 mg/m2 twice daily if required (maximum total daily dose of 3 g).

Liver transplant
Adults
- The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
- The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
- Take 6 capsules in the morning and then 6 capsules in the evening.
Children
- Capsules are only appropriate for children who are capable of swallowing solid medicine without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription. If you are not sure, talk to your doctor or pharmacist before use.
- The dose given will vary depending on the size of the child.
- Your child’s doctor will decide the most appropriate dose based on your child’s height and weight (body surface area – measured as square metres or “m2”). The recommended initial dose is 600 mg/m² taken twice a day. The dose should be individualised based on the doctor’s clinical assessment. If well tolerated, the dose can be increased to 900 mg/m2 twice daily if required (maximum total daily dose of 3 g).

Taking the medicine
Swallow your capsules whole with a glass of water
- Do not break or crush them
- Do not take any capsules that have broken open or split.

Take care not to let any powder from inside a broken capsule get into your eyes or mouth.
- If this happens, rinse with plenty of plain water.

Take care not to let any powder from inside a broken capsule get onto your skin.
- If this happens, wash the area thoroughly with soap and water.

If you take more CellCept than you should
If you take more CellCept than you should, talk to a doctor or go to a hospital straight away. Also do this if someone else accidentally takes your medicine. Take the medicine pack with you.

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 missed dose.

If you stop taking CellCept
Do not stop taking CellCept unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, CellCept can cause side effects, although not everybody gets them.

Talk to a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- you have a sign of infection such as a fever or sore throat
- you have any unexpected bruising or bleeding
- rash, itching, hives, breathlessness or difficult breathing, wheezing or coughing, lightheadedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalized itching, skin reddening and facial/throat swelling (symptoms of severe allergic reaction)

Usual problems
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:
- the number of your blood cells or signs of infections

Fighting infections
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.

Lymph and skin cancer
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of patients on CellCept have developed cancer of the lymphoid tissues and skin.

General unwanted effects
You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.

Other unwanted effects may include:
Skin problems such as:
- acne, cold sores, shingles, skin growth, hair loss, rash, itching.

Urinary problems such as:
- blood in the urine.

Digestive system and mouth problems such as:
- swelling of the gums and mouth ulcers,
- inflammation of the pancreas, colon or stomach,
- gastrointestinal disorders including bleeding,
- liver disorder,
- diarrhoea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problems such as:
- feeling dizzy, drowsy or numb,
- tremor, muscle spasms, convulsions,
- feeling anxious or depressed, changes in your mood or thoughts.

Heart and blood vessel problems such as:
- change in blood pressure, accelerated heartbeat, widening of blood vessels.

Lung problems such as:
- pneumonia, bronchitis,
- shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness.
- fluid on the lungs or inside the chest,

sinus problems.

Other problems such as:
- weight loss, gout, high blood sugar, bleeding, bruising.

Additional side effects in children and adolescents
Children, especially those under 6 years old, may be more likely than adults to have some side effects, including diarrhoea, vomiting, infections, fewer red cells and fewer white cells in the blood, and possibly lymph or skin cancer.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CellCept

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Do not store above 25 °C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CellCept contains
- The active substance is mycophenolate mofetil.
Each capsule contains 250 mg mycophenolate mofetil.
- The other ingredients are:
- CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90), magnesium stearate (see section 2 “CellCept contains sodium”)
- Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), potassium hydroxide, shellac.

What CellCept looks like and contents of the pack
- CellCept capsules are oblong-shaped with one end blue and the other end brown. They have “CellCept 250” printed in black on the capsule cap and “Roche” printed in black on the capsule body.
- They are available as a carton of 100 or 300 capsules (both in blister packs of 10) or as a multipack containing 300 (3 packs of 100) capsules. Not all pack sizes may be marketed.

Marketing Authorisation 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien,
Luxembourg/Luxemburg
N.V. Roche S.A.
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831

България
Рош България ЕООД
Тел: +359 2 474 5444

Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111

Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99

Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438000

Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140

Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00

Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380

Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739

Ελλάδα, Kύπρος
Roche (Hellas) A.E.
Ελλάδα
Τηλ: +30 210 61 66 100

Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88

España
Roche Farma S.A.
Tel: +34 - 91 324 81 00

Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00

France
Roche
Tél: +33 (0)1 47 61 40 00

România
Roche România S.R.L.
Tel: +40 21 206 47 01

Hrvatska
Roche d.o.o.
Tel: + 385 1 47 22 333

Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00

Ireland, Malta
Roche Products (Ireland) Ltd.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700

Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201

Ísland
Roche Pharmaceuticals A/S c/o Icepharma hf
Sími: +354 540 8000

Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500

Italia
Roche S.p.A.
Tel: +39 - 039 2471
Sverige
Roche AB
Tel: +46 (0) 8 726 1200

This leaflet was last revised in

Other sources of information

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

Package leaflet: CellCept 500 mg powder for concentrate for solution for infusion / mycophenolate mofetil

1. What CellCept is and what it is used for

CellCept contains mycophenolate mofetil:
- This belongs to a group of medicines called “immunosuppressants”.
CellCept is used to prevent the body rejecting a transplanted organ:
- A kidney or liver.
CellCept should 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 miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.

Your doctor will speak to you 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 fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions”, “Contraception”, and “Pregnancy and breast-feeding”.

Do not take CellCept:
- If you are allergic to mycophenolate mofetil, mycophenolic acid, polysorbate 80 or any of the other ingredients in this medicine (listed in section 6)
- If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
- If you are pregnant or planning 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 have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before having CellCept.

Warnings and precautions
Talk to your doctor or nurse straight away before starting treatment with CellCept:
- If you are older than 65 years as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding and pulmonary oedema when compared to younger patients
- If you have a sign of infection such as a fever or sore throat
- If you have any unexpected bruising or bleeding
- If you have ever had a problem with your digestive system such as a stomach ulcer
- If you are planning to become pregnant or if you get pregnant while you or your partner are taking CellCept.
- If you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome

If any of the above apply to you (or you are not sure), talk to your doctor or nurse straight away before starting treatment with CellCept.

The effect of sunlight
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
- wearing protective clothing that also covers your head, neck, arms and legs
- using a sunscreen with a high protection factor.

Children
Do not administer this medicine to children because safety and efficacy of infusions to paediatric patients have not been established.

Other medicines and CellCept
Tell your doctor or nurse 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 can affect the way some other medicines work. Also other medicines can affect the way CellCept works.

In particular, tell your doctor or nurse if you are taking any of the following medicines before you start CellCept:
- azathioprine or other medicines that suppress your immune system – given after a transplant operation
- cholestyramine – used to treat high cholesterol
- rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
- phosphate binders – used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their 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 vaccination (a live vaccine) while having CellCept, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.

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.

Contraception in women taking CellCept
If you are a woman who could become pregnant, you must use an effective method of contraception with CellCept. This includes:
- Before you start taking CellCept

- During your entire treatment with CellCept
- For 6 weeks after you stop taking CellCept.
Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.

You cannot become pregnant if any of the following conditions applies to you:
- You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)
- Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
- Your womb (uterus) has been removed by surgery (hysterectomy)
- Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
- You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner’s syndrome or uterine agenesis
- You are a child or teenager who has not started having periods.

Contraception in men taking CellCept
The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution, you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.

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

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
- You plan to become pregnant.
- You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
- You have sex without using effective methods of contraception.
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking CellCept until you see him or her.

Pregnancy
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23- 27 %) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)). Your baby may be affected by one or more of these.

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

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

CellCept contains polysorbate
This medicine contains 25 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

CellCept contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to take CellCept

CellCept is usually given by a doctor or nurse in hospital. It is given as a slow drip (infusion) into a vein.

How much to take
The amount you take depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent rejection of your transplant organ.

Kidney transplant
Adults
- The first dose is given within 24 hours of the transplant operation.
- The daily dose is 2 g of the medicine taken as 2 separate doses.
- This will be given as 1 g in the morning and then 1 g in the evening.

Liver transplant
Adults
- The first dose is given to you as soon as possible after the transplant operation.
- You will have the medicine for at least 4 days.
- The daily dose is 2 g of the medicine taken as 2 separate doses.
- This will be given as 1 g in the morning and then 1 g in the evening.
- When you are able to swallow, you will be given this medicine by mouth.

Making up the medicine
The medicine comes as a powder. This needs mixing with glucose before using. Your doctor or nurse will make up the medicine and give it to you. They will follow the instructions under section 7 “Making up the medicine”.

If you take more CellCept than you should
If you think that you have had too much medicine, talk to your doctor or nurse straight away.

If you forget to take CellCept
If a dose of CellCept is missed, this will be given to you as soon as possible. Your treatment will then continue at the normal times.

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

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, CellCept can cause side effects, although not everybody gets them.

Talk to a doctor or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- you have a sign of infection such as a fever or sore throat
- you have any unexpected bruising or bleeding
- rash, itching, hives, breathlessness or difficult breathing, wheezing or coughing, lightheadedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalized itching, skin reddening and facial/throat swelling (symptoms of severe allergic reaction)

Usual problems
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:
- the number of your blood cells or signs of infections.

Fighting infections
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.

Lymph and skin cancer
As can happen in patients having this type of medicine (immune-suppressants), a very small number of patients on CellCept have developed cancer of the lymphoid tissues and skin.

General unwanted effects
You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.

Other unwanted effects may include:
Skin problems such as:
- acne, cold sores, skin growth, shingles, hair loss, rash, itching.

Urinary problems such as:
- blood in the urine.

Digestive system and mouth problems such as:
- swelling of the gums and mouth ulcers,
- inflammation of the pancreas, colon or stomach,
- gastrointestinal disorders including bleeding,
- liver disorders,
- diarrhoea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.

Nervous system problems such as:
- feeling drowsy or numb,
- tremor, muscle spasms convulsions,
- feeling anxious or depressed, changes in your mood or thoughts.

Heart and blood vessel problems such as:
- change in blood pressure, blood clots, accelerated heartbeat
- pain, redness and swelling of the blood vessels where you had the infusion.

Lung problems such as:
- pneumonia, bronchitis,

shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness
fluid on the lungs or inside the chest,
sinus problems.

Other problems such as:
- weight loss, gout, high blood sugar, bleeding, bruising.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CellCept

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Powder for concentrate for solution for infusion: do not store above 30 °C.
Reconstituted solution and the diluted solution: store between 15 °C and 30 °C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What CellCept contains
- The active substance is mycophenolate mofetil.
Each vial contains 500 mg mycophenolate mofetil
- The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride (see section 2 “CellCept contains polysorbate” and “CellCept contains sodium”).

What CellCept looks like and contents of the pack
- CellCept is provided as white to off-white powder in a 20 ml type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap.
- The reconstituted solution is slightly yellow.
- It is available in packs of 4 vials.

7.
Making up the medicine

Method and route of administration
CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.

The contents of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 ml of glucose intravenous infusion 5% each. A further dilution with glucose intravenous infusion 5% is required to a final concentration of 6 mg/ml. This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 ml) must be further diluted into 140 ml glucose intravenous infusion 5% solution. If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.

Take care not to let the made-up medicine get into your eyes.
∙
If this happens, rinse your eyes with plain water.
Take care not to let the made-up medicine get on your skin.
∙
If this happens, wash the area thoroughly with soap and water.
CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous infusion. The infusion flow rate should be controlled to equate to a 2-hour period of administration.

CellCept intravenous solution should never be administered by rapid or bolus intravenous injection.

Marketing Authorisation 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien,
Luxembourg/Luxemburg
N.V. Roche S.A.
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831

България
Рош България ЕООД
Тел: +359 2 474 5444

Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111

Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99

Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438000

Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140

Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00

Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380

Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739

Ελλάδα, Kύπρος
Roche (Hellas) A.E.
Ελλάδα
Τηλ: +30 210 61 66 100

Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88

España
Portugal

Roche Farma S.A.
Tel: +34 - 91 324 81 00

Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00

France
Roche
Tél: +33 (0)1 47 61 40 00

România
Roche România S.R.L.
Tel: +40 21 206 47 01

Hrvatska
Roche d.o.o.
Tel: + 385 1 47 22 333

Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00

Ireland, Malta
Roche Products (Ireland) Ltd.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700

Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201

Ísland
Roche Pharmaceuticals A/S c/o Icepharma hf
Sími: +354 540 8000

Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500

Italia
Roche S.p.A.
Tel: +39 - 039 2471
Sverige
Roche AB
Tel: +46 (0) 8 726 1200

This leaflet was last revised in

Other sources of information

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

Package leaflet: CellCept 1 g/5 ml powder for oral suspension / mycophenolate mofetil

1. Tap the bottom of the closed bottle several times to loosen the powder.

2. Measure 94 ml of purified water in a measuring cylinder.

3. Add about half of the total amount of purified water to the bottle.

• Then shake the closed bottle well for about 1 minute.

4. Add the rest of the water.

• Then shake the closed bottle well for about another minute.

5. Take off the child safety bottle cap and push the bottle adapter into the neck of the bottle.

6. Then, tightly close the bottle with the child safety bottle cap.

• This will make sure that the bottle adapter and child safety bottle cap are in the right position.
7.
Write the expiry date of the made-up medicine on the bottle label.
• The made-up medicine can be used for 2 months.

Marketing Authorisation 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien,
Luxembourg/Luxemburg
N.V. Roche S.A.
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831

България
Рош България ЕООД
Тел: +359 2 474 5444

Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111

Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99

Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438000

Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140

Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00

Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380

Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739

Ελλάδα, Kύπρος
Roche (Hellas) A.E.
Ελλάδα
Τηλ: +30 210 61 66 100

Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88

España
Roche Farma S.A.
Tel: +34 - 91 324 81 00

Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00

France
Roche
Tél: +33 (0)1 47 61 40 00

România
Roche România S.R.L.
Tel: +40 21 206 47 01

Hrvatska
Roche d.o.o.
Tel: + 385 1 47 22 333

Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00

Ireland, Malta
Roche Products (Ireland) Ltd.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700

Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201

Ísland
Roche Pharmaceuticals A/S c/o Icepharma hf
Sími: +354 540 8000

Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500

Italia
Roche S.p.A.
Tel: +39 - 039 2471
Sverige
Roche AB
Tel: +46 (0) 8 726 1200

This leaflet was last revised in

Other sources of information

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

Package leaflet: CellCept 500 mg film-coated tablets / mycophenolate mofetil

1. What CellCept is and what it is used for

CellCept contains mycophenolate mofetil:
- This belongs to a group of medicines called “immunosuppressants”.
CellCept is used to prevent the body rejecting a transplanted organ in adults and children:
- A kidney, heart or liver.
CellCept should 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 miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.

Your doctor will speak to you 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 fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions”, “Contraception”, “Pregnancy and breast-feeding”.

Do not take CellCept:
- If you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in section 6)
- If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
- If you are pregnant or planning 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 applies to you. If you are not sure, talk to your doctor or pharmacist before taking CellCept.

Warnings and precautions
Talk to your doctor straight away before starting treatment with CellCept:
- If you are older than 65 years as you may have an increased risk of developing adverse events such as certain viral infections, gastrointestinal bleeding and pulmonary oedema when compared to younger patients
- If you have a sign of infection such as a fever or sore throat
- If you have any unexpected bruising or bleeding
- If you have ever had a problem with your digestive system such as a stomach ulcer
- If you are planning to become pregnant or if you get pregnant while you or partner are taking CellCept.
- If you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-Seegmiller syndrome If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting treatment with CellCept.

The effect of sunlight
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
- wearing protective clothing that also covers your head, neck, arms and legs
- using a sunscreen with a high protection factor.

Children
Children, especially those under 6 years old, may be more likely than adults to have some side effects, including diarrhoea, vomiting, infections, fewer red cells and fewer white cells in the blood, and possibly lymph or skin cancer.

Tablets are only appropriate for children who are capable of swallowing solid medicine without the risk of choking. The medicine should therefore only be given in line with the doctor’s prescription.

If you are not sure about anything for your child’s treatment, talk to your doctor or pharmacist before use.

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 can affect the way some other medicines work. Also other medicines can affect the way CellCept works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept:
- azathioprine or other medicines that suppress your immune system – given after a transplant operation
- cholestyramine – used to treat high cholesterol
- rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)
- antacids or proton pump inhibitors – used for acid problems in your stomach such as indigestion
- phosphate binders – used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood.
- antibiotics – used to treat bacterial infections
- isavuconazole – used to treat fungal infections
- telmisartan – used to treat high blood pressure