CellCept - patient leaflet, side effects, dosage

- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

• 1. What CellCept is and what it is used for

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

• 3. How to take CellCept

• 4. Possible side effects

• 5. How to store CellCept

• 6. Contents of the pack and other information

• 7. Making up the medicine

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 your 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” 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 Pregnancy, contraception 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 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
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing – you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).

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 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.

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 × 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 (IV) infusion. The infusion flow rate should be controlled to equate to a 2-hour period of administration.

CellCept IV 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-Str. 1, 79639 Grenzach Wyhlen, Germany.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien N.V. Roche S.A. Tél/Tel: +32 (0) 2 525 82 11	Lietuva UAB “Roche Lietuva” Tel: +370 5 2546799
Efc^rapufl Pom Etarapua EOOfl Tea: +359 2 818 44 44	Luxembourg/Lu­xemburg (Voir/siehe Belgique/Belgien)
Česká republika Roche s. r. o. Tel: +420 – 2 20382111	Magyarország Roche (Magyarország) Kft. Tel: +36 – 1 279 4500
Danmark Roche a/s Tlf: +45 – 36 39 99 99	Malta (See Ireland)
Deutschland Roche Pharma AG Tel: +49 (0) 7624 140	Nederland Roche Nederland B.V. Tel: +31 (0) 348 438050
Eesti Roche Eesti OÜ Tel: + 372 – 6 177 380	Norge Roche Norge AS Tlf: +47 – 22 78 90 00
EZZáSa Roche (Hellas) A.E. Tql: +30 210 61 66 100	Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
España Roche Farma S.A. Tel: +34 – 91 324 81 00	Polska Roche Polska Sp.z o.o. Tel: +48 – 22 345 18 88
France Roche Tél: +33 (0)1 47 61 40 00	Portugal Roche Farmacéutica Química, Lda Tel: +351 – 21 425 70 00

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

CellCept 1 g/5 ml powder for oral suspension 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 symptoms 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.

What is in this leaflet :

• 1. What CellCept is and what it is used for

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

• 3. How to take CellCept

• 4. Possible side effects

• 5. How to store CellCept

• 6. Contents of the pack and other information

• 7. Making-up the medicine

1. What CellCept is and what it is used for

CellCept contains mycophenolate mofetil.

• This belongs to a group of medicines called “immuno-suppressants”.

CellCept is used to prevent your body rejecting a transplanted organ.

• 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” and “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 Pregnancy, contraception 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 have a rare problem with your metabolism called “phenylketonuria” which runs in families
• 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 covers your head, neck, arms and legs
• using a sunscreen with a high protection factor.

Children

Do not give this medicine to children younger than 2 years because based on the limited safety and efficacy data for this age group no dose recommendations can be made.

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 which 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 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.

Important information about some of the ingredients of CellCept

• CellCept contains aspartame. If you have a rare problem with your metabolism called “phenylketonuria”, talk to your doctor before you start taking this medicine.
• CellCept contains sorbitol (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

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

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 10 ml suspension (2 g of the medicine) taken as 2 separate doses.
• Take 5 ml suspension in the morning and then 5 ml suspension in the evening.

Children (aged 2 to 18 years)

• The dose given will vary depending on the size of the child.
• Your 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 dose is 600 mg/m2 taken twice a day.

Heart transplant

Adults

• The first dose is given within 5 days of the transplant operation.
• The daily dose is 15 ml suspension (3 g of the medicine) taken as 2 separate doses.
• Take 7.5 ml suspension in the morning and then 7.5 ml suspension in the evening.

Children

• There is no information for the use of CellCept in children with a heart transplant.

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 medications.
• The daily dose is 15 ml suspension (3 g of the medicine) taken as 2 separate doses.
• Take 7.5 ml suspension in the morning and then 7.5 ml suspension in the evening.

Children

• There is no information for the use of CellCept in children with a liver transplant.

Making up the medicine

The medicine comes as a powder. This needs mixing with purified water before using. Your pharmacist will normally make up the medicine for you. If you need to do it yourself, see section 7 “Making up the medicine”

Taking the medicine

You need to use the dispenser and bottle adapter supplied with the medicine to measure the dose. Try not to inhale the dry powder. Also, try not to get it on your skin, inside your mouth or nose. 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 onto your skin.
• If this happens, wash the area thoroughly with soap and water.

• 1. Shake the closed bottle well for about 5 seconds before each use.

• 2. Take off the child safety bottle cap.

• 3. Take the dispenser and push the plunger completely down toward the tip of the dispenser.

• 4. Then put the tip of the dispenser firmly into the opening of the bottle adapter.

• 5. Turn the whole thing upside down (bottle and dispenser – see picture below).

• 6. Pull the plunger out slowly.

Keep pulling it out until the desired amount of medicine is in the dispenser.

• 7. Turn the whole thing back round the right way.

Holding onto the body of the dispenser, carefully pull the dispenser out of the bottle adapter.

The bottle adapter should stay in the bottle.

Put the end of the dispenser directly into your mouth and swallow the medicine.

Do not mix the medicine with any other liquid when you swallow it. Close the bottle with the child safety bottle cap after each use.

• 8. Immediately after use – take the dispenser to pieces and rinse it under running tap water. Allow it to dry in the air before using it again.

Do not boil the oral dispenser. Do not use solvent-containing wipes for cleaning. Do not use cloths or wipes for drying.

Contact your doctor, pharmacist or nurse if both dispensers are lost or damaged, and they will advise you on how to continue to take your medication.

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 medicine, 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
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing – you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).

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.

Children may be more likely than adults to have some side effects. These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.

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 disorders,
• 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.

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 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 bottle label after EXP.
• The shelf-life of the reconstituted suspension is two months. Do not use the suspension past this

expiry date.

• Powder for oral suspension: do not store above 30°C.
• Reconstituted suspension: do not store above 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.

Contents of the pack and other information

What CellCept contains

• – The active substance is mycophenolate mofetil.

Each bottle contains 35 g mycophenolate mofetil.

• – The other ingredients are sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, mixed fruit flavour, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), citric acid anhydrous. Please also read in section 2 “Important information about some of the ingredients of CellCept”.

• – * contains phenylalanine equivalent to 2.78 mg/5 ml of suspension.

What CellCept looks like and contents of the pack

• – Each bottle of 110 g powder for oral suspension contains 35 g of mycophenolate mofetil. Reconstitute with 94 ml of purified water. When reconstituted, the volume of the suspension is 175 ml, providing a usable volume of 160 – 165 ml. 5 ml of the reconstituted suspension contain 1 g of mycophenolate mofetil.

• – A bottle adapter and 2 oral dispensers are also provided.

• 7. Making up the medicine

Your pharmacist will normally make up the medicine for you. If you need to do it yourself, follow the steps below:

Try not to inhale the dry powder. Also try not to get it on your skin, inside your mouth or nose.

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.

• 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-Str. 1, 79639 Grenzach Wyhlen, Germany.

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

België/Belgiqu­e/Belgien N.V. Roche S.A. Tél/Tel: +32 (0) 2 525 82 11	Lietuva UAB “Roche Lietuva” Tel: +370 5 2546799
Efc^rapufl Pom Etnrapua EOOfl	Luxembourg/Lu­xemburg (Voir/siehe Belgique/Belgien)

Ten: +359 2 818 44 44

Česká republika Roche s. r. o. Tel: +420 – 2 20382111	Magyarország Roche (Magyarország) Kft. Tel: +36 – 1 279 4500
Danmark Roche a/s	Malta (See Ireland)

Tlf: +45 – 36 39 99 99

Deutschland Roche Pharma AG Tel: +49 (0) 7624 140	Nederland Roche Nederland B.V. Tel: +31 (0) 348 438050
Eesti Roche Eesti OÜ Tel: + 372 – 6 177 380	Norge Roche Norge AS Tlf: +47 – 22 78 90 00
EXÀàôa Roche (Hellas) A.E. Tql: +30 210 61 66 100	Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
España Roche Farma S.A. Tel: +34 – 91 324 81 00	Polska Roche Polska Sp.z o.o. Tel: +48 – 22 345 18 88
France Roche Tél: +33 (0)1 47 61 40 00	Portugal Roche Farmacéutica Química, Lda Tel: +351 – 21 425 70 00
Hrvatska Roche d.o.o. Tel: + 385 1 47 22 333	Romania Roche Romania S.R.L. Tel: +40 21 206 47 01
Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700	Slovenija Roche farmacevtska družba d.o.o. Tel: +386 – 1 360 26 00
Ísland Roche a/s c/o Icepharma hf Sími: +354 540 8000	Slovenská republika Roche Slovensko, s.r.o. Tel: +421 – 2 52638201
Italia Roche S.p.A. Tel: +39 – 039 2471	Suomi/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500

United Kingdom (Northern Ireland)

Roche Products (Ireland) Ltd.

Tel: +44 (0) 1707 366000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

CellCept 500 mg 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.

What in this leaflet :

• 1. What CellCept is and what it is used for

• 2. What you need to know before you take 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.

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

CellCept is used to prevent your body rejecting a transplanted organ.

• 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” and “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 Pregnancy, contraception 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

Do not give this medicine to children younger than 2 years because based on the limited safety and efficacy data for this age group no dose recommendations can be made.

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 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 sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, 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 4 tablets (2 g of the medicine) taken as 2 separate doses.
• Take 2 tablets in the morning and then 2 tablets in the evening.

Children (aged 2 to 18 years)

• The dose given will vary depending on the size of the child.
• Your 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 dose is 600 mg/m2 taken twice a day.

Heart transplant

Adults

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

Children

• There is no information for the use of CellCept in children with a heart transplant.

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 6 tablets (3 g of the medicine) taken as 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in the evening.

Children

• There is no information for the use of CellCept in children with a liver transplant.

Taking the medicine

• Swallow your 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, 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 transplanted organ.

If you have any further questions on the use of this medicine, 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
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing – you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).

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.

Children may be more likely than adults to have some side effects. These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.

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 disorders
• 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.

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 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 30 °C.
• Keep in outer carton in order to protect from light.
• 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 film coated tablet contains

• – The active substance is mycophenolate mofetil.

Each tablet contains 500 mg mycophenolate mofetil.

• – The other ingredients are:

• CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium, magnesium stearate
• tablet coating: hydroxypropyl methycellulose, hydroxypropyl cellulose, titanium dioxide (E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), red iron oxide (E172).

What CellCept looks like and contents of the pack

• – CellCept tablets are lavender-coloured and caplet-shaped. They have “CellCept 500” engraved on

one side and “Roche” on the other.

• – They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs of 50) tablets. Not all pack sizes may be marketed.

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATIONS

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSURs for mycophenolate mofetil, mycophenolic acid, the scientific conclusions of CHMP are as follows:

In view of available data on severe course of COVID-19 infection from the literature and in view of a plausible mechanism of action, the PRAC considers a causal relationship between mycophenolate mofetil, mycophenolic acid and severe course of COVID-19 infection is at least a reasonable possibility. The PRAC concluded that the product information of the centrally authorised medicinal products and nationally authorised medicinal products containing mycophenolate mofetil, mycophenolic acid should be amended accordingly.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisations

On the basis of the scientific conclusions for mycophenolate mofetil, mycophenolic acid the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing mycophenolate mofetil, mycophenolic acid is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisations should be varied.

142

contains phenylalanine equivalent to 2.78 mg/5 ml of suspension.