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MYCOPHENOLATE MOFETIL 250 MG HARD CAPSULES

Active substance(s): MYCOPHENOLATE MOFETIL

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Package leaflet: Information for the patient
Mycophenolate mofetil 250 mg Hard Capsules
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 is in this leaflet:
1. What Mycophenolate mofetil is and what it is used for
2. What you need to know before you take Mycophenolate mofetil
3. How to take Mycophenolate mofetil
4. Possible side effects
5. How to store Mycophenolate mofetil
6. Contents of the pack and other information

1. What Mycophenolate mofetil is and what it is used for
The full name of your medicine is Mycophenolate mofetil 250 mg Hard Capsules. In this leaflet the shorter
name Mycophenolate mofetil is used.
Mycophenolate mofetil contains mycophenolate mofetil which belongs to a group of medicines called
immunosuppressants.
Mycophenolate mofetil is used to prevent your body rejecting a transplanted kidney, heart or liver. It is
used together with other medicines known as ciclosporin and corticosteroids.

2. What you need to know before you take Mycophenolate mofetil
WARNING
Mycophenolate mofetil 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 mofetil 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 mofetil. See also further information in this section under “Warnings and precautions”
and “Pregnancy and breast-feeding”.
Do not take Mycophenolate mofetil:
• if you are allergic to mycophenolate, mycophenolic acid or any of the other ingredients of this medicine
(listed in section 6).
• if you are breast-feeding.
• if you are a woman who could be pregnant and you have not provided a negative pregnancy test before
your first prescription as mycophenolate mofetil causes birth defects and miscarriage.
• if you are pregnant, or planning to become pregnant or think you may be pregnant.

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 Mycophenolate mofetil.
Warnings and precautions
Talk to your doctor or pharmacist before taking Mycophenolate mofetil
• If you have ever had a problem with your digestive system such as a stomach ulcer.
• If you have a rare enzyme hereditary disorder known as deficiency of hypoxanthine-guanine
phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller Syndrome.
During treatment
When you are taking Mycophenolate mofetil, you should talk to your doctor or pharmacist if you develop
signs of infection such as fever, sore throat, or you notice any unexpected bruising or bleeding. These could
be signs of changes in the blood which may be a side effect of Mycophenolate mofetil (see also section 4,
‘Possible side effects’). Your doctor should check your blood counts regularly during treatment.
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist straight away
before taking Mycophenolate mofetil.
The effect of sunlight
Mycophenolate mofetil 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, which also covers your head, neck, arms and legs.
• using a sunscreen with a high protection factor.
Other medicines and Mycophenolate mofetil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This includes medicines obtained without a prescription, including herbal medicines. This is because
Mycophenolate mofetil can affect the way some other medicines work. Also other medicines can affect the
way Mycophenolate mofetil works.
In particular, tell you doctor or pharmacist if you are taking any of the following medicines before you start
taking Mycophenolate mofetil:
• azathioprine or other medicines that suppress your immune system such as ciclosporin, belatacept,
sirolimus and tacrolimus- normally given after a transplant operation
• cholestyramine - used to treat high cholesterol
• telmisartan (used to treat high blood pressure)
• antibiotics - such as norfloxacin, metronidazole, ciprofloxacin, amoxicillin plus clavulanic acid (coamoxiclav) or rifampicin - 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 –
such as magnesium antacids, lansoprazole or pantoprazole
• phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets
absorbed into their blood such as sevelamer
• aciclovir, ganciclovir – used to treat viral infections
• probenecid – normally used to prevent some kidney problems which can occur after taking certain
medicines.
Vaccines
If you need to have a vaccine (a live vaccine) while taking Mycophenolate mofetil, talk to your doctor or
pharmacist first. Your doctor will have to advise you on what vaccines you can have.
Additional precautions

You must not donate blood during treatment with Mycophenolate mofetil and for at least 6 weeks after
stopping treatment. Men must not donate semen during treatment with Mycophenolate mofetil and for at
least 90 days after stopping treatment.
Pregnancy, contraception and breast-feeding
Contraception in women taking Mycophenolate mofetil
If you are a woman who could become pregnant you must always use two effective methods of
contraception with Mycophenolate mofetil. This includes:




Before you start taking Mycophenolate mofetil.
During your entire treatment with Mycophenolate mofetil.
For 6 weeks after you stop taking Mycophenolate mofetil.

Talk to your doctor about the most suitable contraception for you. This will depend on your individual
situation. 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 are a woman who is not capable of becoming pregnant if any of the following 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 salpingooophorectomy)

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 Mycophenolate mofetil
You must always use condoms during treatment and for 90 days after you stop taking Mycophenolate
mofetil.
If you are planning to have a child, your doctor will talk to you about the risks and the alternative
treatments you can take to prevent rejection of your transplant organ.
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 an effective method of contraception.

If you do become pregnant during the treatment with mycophenolate, you must inform your doctor
immediately. However, keep taking Mycophenolate mofetil 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 Mycophenolate mofetil if you are breast-feeding. This is because this medicine can pass into
the mother’s milk to such an extent that effects on the breast-fed infants are likely.
Driving and using machines
Mycophenolate mofetil is not likely to affect you being able to drive or use tools or machines.

3. How to take Mycophenolate mofetil
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure.
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 you from rejecting your transplant organ.

Kidney transplant
Adults (including elderly people)
- The first dose is given within 72 hours after the transplant operation.
- The recommended daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
- This means taking 4 capsules in the morning then 4 capsules in the evening.
Use in children and adolescents aged 2 to 18 years
- The recommended 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.
Use in children below the age of 2 years of age
- There is no information for the use of mycophenolate mofetil in children with a kidney transplant and
therefore the use is not recommended.
Heart transplant
Adults (including elderly people)
- 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.
Use in children and adolescents
- There is no information for the use of mycophenolate mofetil in children with a heart transplant.
Liver transplant
Adults (including elderly people)
- The first dose of oral Mycophenolate mofetil will normally be given to you at least 4 days after the
transplant operation and when you are able to swallow oral medication.
- 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.
Use in children and adolescents
- There is no information for the use of mycophenolate mofetil in children with a liver transplant.
Patients with kidney problems
If you have severe kidney problems, including those which persist after a kidney transplant, your doctor
may recommend a lower dose and/or monitor you carefully.
Patients with serious liver problems
If you have severe liver problems, your doctor may monitor you carefully.
Method of administration
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 breathe in or 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 Mycophenolate mofetil than you should
If you take more Mycophenolate mofetil 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 Mycophenolate mofetil
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 forgotten dose.
If you stop taking Mycophenolate mofetil
Do not stop taking Mycophenolate mofetil 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, this medicine can cause side effects, although not everybody gets them.
Contact your doctor straight away or go to the nearest hospital casualty department if you notice any
of the following serious side effects-you may need urgent medical treatment:
Very common (may affect more than 1 in 10 people)
• decrease in normal amounts of different blood cells, which result in frequent infections, unexpected
bruising or bleeding, fever or sore throat. Your doctor will do regular blood tests to check for any
changes in the number of your blood cells.
• serious bacterial infection of the blood (sepsis) with high fever, chills, headache, confusion and rapid
breathing.
• fungal or viral infections of the digestive system, or infections of the urinary tract.
Common (may affect up to 1 in 10 people)

• inflammation of the liver. You may notice yellowing of the skin and whites of the eyes, pale stools or
dark urine. In blood tests, you doctor may notice increased levels of bilirubin in the blood.
• skin cancer or non-cancerous growths of the skin.
• kidney problems.
• inflammation and infections of the lungs (which could be serious and include pneumonia, atypical
mycobacterial infection or tuberculosis).
• ulcers of the stomach or upper gut (duodenum), bowel obstruction, inflammation of the large bowel
(colon) or stomach and bowel lining (peritoneum), gastrointestinal bleeding (you may notice black, tarry
poo or if you are sick it may look like it contains coffee granules).
• inflammation of the pancreas (you may have severe abdominal pain which reaches round into the back).
• convulsions (fits).
• disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing
and sometimes muscle weakness in the arms or legs (myasthenic syndrome).
Uncommon (may affect up to 1 in 100 people)
• severe reduction in the number of white blood cells, which make infections likely (agranulocytosis).
Symptoms include high temperature and ulcers in the mouth and throat.
• proliferation of the lymphatic tissue, including malignant tumours.
Not known (frequency cannot be estimated from the available data)
• wheezing or difficulty breathing, difficulty swallowing, because of the sudden narrowing in the throat,
swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin, which may
be signs of a serious allergic reaction (such as anaphylaxis, angioedema).
• vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding
what others say, and muscle weakness , symptoms of a severe infection of the brain cells (Progressive
Multifocal Leukoencephalopathy).
• inflammation or infections of the heart and its valves and of the membrane that covers the brain
and spinal cord (meningitis) - you may have severe headache, sensitivity to light and a rash that does not
blanch when pressed.
• abnormal scarring and thickening of the lung tissue (pulmonary fibrosis), causing shortness of breath,
cough, and a condition in which the lung airways are abnormally dilated (bronchiectasis). Talk to your
doctor if you develop a persistent cough or breathlessness.
• other lung problems such as serious infections and inflammation of lungs, condition in which you may
have fever, chills, shortness of breath, cough occasionally with blood.
Other possible side effects
Very common (may effect more than 1 in 10 people)
• diarrhoea, vomiting, feeling sick (nausea), stomach pain.
• cold sores and shingles.
Common (may affect up to 1 in 10 people)
• changes in different laboratory parameters, including increase in liver enzymes, and changes in renal
parameters such as creatinine, urea, blood pH, potassium, blood sugar, blood lipids, cholesterol,
phosphates, magnesium, calcium and uric acid. Your doctor will do regular blood tests to check for any
changes in the amount of things like sugar, fat or cholesterol in your blood.
• altered blood count (increased or decreased number of cells in the blood).
• disorders of the digestive system such as constipation, indigestion, excessive wind, belching.
• inflammation of the mouth, oesophagus, stomach, intestine.
• increased tension in the muscles, shaking and joint pain.
• confusion, agitation, depression, anxiety, changes in your mood or thoughts, drowsiness, sleeplessness,
dizziness, tingling or numbness, change of the sense of taste, loss of appetite, weight loss.
• inflammation of the sinuses, flu symptoms, runny and itchy nose.
• infections of the respiratory and gastrointestinal tract.
• fungal infections of the skin and vagina, acne, skin growth, hair loss and rashes.

• changes in blood pressure, faster heartbeat, widening of blood vessels.
• fluid on lungs/chest cavity, gout.
• fluid retention in the body, discomfort, lethargy and unusual weakness bleeding, tenderness or swelling
of the gums.
Side effects in children and adolescents
Children may be more likely than adults to have side effects such as diarrhoea, infections, serious bacterial
infection of the blood (sepsis), fewer white cells and fewer red cells in the blood.
Elderly patients
Elderly patients receiving mycophenolate mofetil as part of a combination immunosuppressive therapy may
be at increased risk of certain infections, fluid build-up in the lungs and bleeding in the intestine.
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 www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mycophenolate mofetil
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from moisture.
Do not use the medicine after the expiry date which is stated on the carton after (EXP). The expiry date
refers to the last day of that month.
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 Mycophenolate mofetil contains
The active substance is mycophenolate mofetil.
The other ingredients are Capsule content - pregelatinised maize starch, povidone, croscarmellose sodium,
magnesium stearate; Capsule shells – Cap: Indigo carmine (E132), titanium dioxide (E171), gelatin,
sodium laurilsulfate Body: red & yellow iron oxides (E172), titanium dioxide (E171), gelatin, sodium
laurilsulfate; Black ink - shellac, black iron oxide (E172) and potassium hydroxide.
What Mycophenolate Mofetil looks like and contents of the pack
Hard capsules with blue cap and brown body imprinted with ‘MCM’ on cap and ‘250’ on body with black
ink containing a white to off white powder.
Available in packs of 100 or 300 capsules per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom

Manufacturer
Gerard Laboratories, 36/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Dr Reddy’s Laboratories (UK) Limited, 6 Riverview Road, Beverly, HU17 OLD, United Kingdom.

This medicinal product is authorised in the Member States of the EEA under the following names:
France: Mycophenolate Mofetil Mylan 250mg, gélule
Italy: Micofenolato Mofetile Mylan Generics Italia
The Netherlands: Mycofenolaat Mofetil Mylan 250 mg, capsule, hard
United Kingdom: Mycophenolate Mofetil 250 mg Hard Capsules
This leaflet was last revised in March 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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