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).
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 • 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

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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.

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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

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• 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.

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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 (see details below). By reporting side
effects, you can help provide more information on the safety of this medicine.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store

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:

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 • 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.

Marketing Authorisation Holder and Manufacturer

Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom.

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

United Kingdom
Roche Products Ltd.
Tel: +44 (0) 1707 366000

This leaflet was last revised in April 2022

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