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MYCOPHENOLATE MOFETIL MYLAN 500 MG FILM-COATED TABLETS

Active substance(s): MYCOPHENOLATE MOFETIL

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Package leaflet: Information for the patient

Mycophenolate Mofetil
500 mg
Film-coated Tablets

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
Mycophenolate Mofetil contains the active substance
mycophenolate mofetil, which belongs to a group of
medicines called immunosuppressants. These medicines
are used to prevent your body rejecting a transplanted
kidney, heart or liver. Mycophenolate Mofetil should be 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 mofetil, mycophenolic
acid or any of the other ingredients of this medicine (listed
in section 6).

• if you are a woman who could be pregnant and you have
not provided a negative pregnancy test before your first
prescription as mycophenolate mofetil 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.
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 are planning to become pregnant or if you get
pregnant while taking Mycophenolate Mofetil
• if you have a rare enzyme hereditary disorder known as
deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and KelleySeegmiller syndrome.
During treatment with Mycophenolate Mofetil, talk to your
doctor or pharmacist:
• if you experience any evidence of infection such as fever or
sore throat
• if you have any unexpected bruising or bleeding
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:
• w
 earing appropriate protective clothing, which also covers
your head, neck, arms and legs
• u
 sing 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 other medicines work. Also other medicines can affect
the way Mycophenolate Mofetil works.
In particular, tell your doctor or pharmacist if you are
taking any of the following medicines before you start
Mycophenolate Mofetil:
• a zathioprine, sirolimus, tacrolimus or other medicines
which suppress your immune system - given after a
transplant operation
• c holestyramine – used to treat high cholesterol
• r ifampicin - an antibiotic used to prevent and treat infections
such as tuberculosis (TB)
• a ntacids or proton pump inhibitors - used for acid problems
in your stomach such as indigestion – for example,
magnesium antacids, lansoprazole or pantoprazole
• p
 hosphate binders – used by people with chronic kidney
failure to reduce how much phosphate gets absorbed into
their blood – for example, sevelamer.
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 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 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.

• y ou 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 small amounts of the medicine can pass into
the mother’s milk.
Driving and using machines
Mycophenolate Mofetil is not likely to affect you being able to
drive or use any tools or machines, however this medicine can
cause you to feel dizzy, sleepy or affect your muscles. If these
happen talk to your doctor or pharmacist before driving or
using machines.

3. How to take Mycophenolate Mofetil

Always take this medicine exactly as your doctor has told you.
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 recommended doses are shown below.
Treatment will continue for as long as you need to prevent you
from rejecting your transplant organ.
Kidney Transplant
Adults
• T he first dose is given within 3 days of the transplant
operation.
• T he recommended daily dose is 4 tablets (2 g of the
medicine) taken as 2 separate doses.
• T ake 2 tablets in the morning and then 2 tablets in
the evening.
Use in children aged 2 to 18 years
• T he dose given will vary depending on the size of the child.
 our doctor will decide the most appropriate dose based
• Y
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 2 years of age
• T here 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
• The first dose is given within 5 days of the transplant
operation.
• The recommended 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.
Use in children
• There is no information for the use of Mycophenolate Mofetil
in children with a heart transplant.
Liver Transplant
Adults
• The first dose of oral Mycophenolate Mofetil will be given to
you at least 4 days after the transplant operation and when
you are able to swallow oral medications.
• The recommended daily dose is 6 tablets (3 g of the active
ingredient) taken as 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in
the evening.
Use in children
• There is no information for the use of Mycophenolate Mofetil
in children with a liver transplant.
Method of administration
• Swallow your tablets whole with a glass of water.
• Do not break or crush them.
• You can take this medicine with or without food.
If you take more Mycophenolate Mofetil than you should
If you take more tablets than you have been told to take, or if
someone else accidentally takes your medicine, immediately
see a doctor or go to a hospital straight away. Your body’s
defence mechanism can be reduced increasing the risk of
infections. 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
Stopping your treatment with Mycophenolate Mofetil may
increase the chance of rejection of your transplanted organ.
Do not stop taking your medicine unless your doctor tells
you to.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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:
Very common - may affect more than 1 in 10 people:
• decrease in the normal amounts of white blood cells, which
can result in frequent infections, causing fever, sore throat
and mouth ulcers. Your doctor will do regular blood tests to
check for any changes in the number of your blood cells

• s erious bacterial infection of the blood (sepsis) with high
fever, chills, headache, confusion and rapid breathing
 vergrowth of certain fungi in the gut, which can cause
• o
you to feel tired or generally unwell, with difficulty thinking
or concentrating
• infection with a virus known as 'CMV' (cytomegalovirus),
which can cause serious problems with the lungs,
liver or bowels. For signs of such problems, read this
section carefully
Common - may affect up to 1 in 10 people
• d
 ecrease in the normal amounts of other blood cells, which
can result in unexpected bruising or bleeding (decreased
platelets) or pale skin and tiredness (decreased red blood
cells). These may be due to a reduction in all types of blood
cells (pancytopenia) or a reduction in the ability of the bone
marrow to produce them
• inflammation of the liver, yellowing of the skin and whites of
the eyes
• s erious infection of the lungs, possibly with a build-up of
fluid (pneumonia), causing you to feel generally unwell with
fever, chills and cough with mucous, which could be foamed
or contain blood
• m
 uscle weakness, which may affect movement, strength,
physical exercise, speech or the face
• s kin cancer
• c onvulsions (fits)
• infection in the tissue of the abdomen, causing pain
and tenderness
• b
 lockage in the bowel causing persistent constipation,
absence of wind, with pain and discomfort
• u
 lcer or bleeding in the stomach or gut, causing severe pain
often following meals, bloating, feeling or being sick, with
blood in the vomit or in the stools
Uncommon - may affect up to 1 in 100 people:
• c ancer of the lymph glands, or non-cancerous growth of
lymph tissue
Not known (frequency cannot be estimated from the
available data):
• w
 heezing or difficulty breathing, difficulty swallowing,
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)
• v ision 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
(endocarditis) and of the membrane that covers the brain
and spinal cord (meningitis). These may cause fever, chills,
tiredness, sore muscles or joints, shortness of breath, cough,
sensitivity of the eyes to light and in serious cases a spotty
rash on the skin
• a bnormal 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.

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• o
 ther serious infections, which may cause breathing
difficulties or cough (tuberculosis), weakness or tiredness,
fever, chills, night sweats, loss of appetite and weight loss
infection of the colon, causing fever, loss of appetite, weight
loss, dehydration, abdominal pain and bloating, feeling or
being sick, diarrhoea (possibly with blood) or worsening of
existing inflammatory bowel disorder (IBS)
• inflammation of the pancreas, which causes severe stomach
pain that spreads to the back
Other possible side effects:
Very common - may affect more than 1 in 10 people:
• diarrhoea, vomiting, feeling sick (nausea), stomach pain
• bacterial, fungal and viral infections of the digestive and
urinary tract, cold sores and shingles.
Common - may affect up to 1 in 10 people:
• changes in the results of some blood tests, including
increase in liver enzymes, tests for kidney function such
as creatinine, levels of potassium, blood sugar, blood fats,
cholesterol, phosphates, magnesium, calcium, uric acid and
other acids. Your doctor will do regular tests to check for any
changes in the amount of these substances in your blood
• altered blood count (increased or decreased number of cells
in the blood)
• kidney problems with increased levels of urea
• disorders of the digestive system such as constipation,
indigestion, excessive wind, belching, inflammation or
infection of the mouth, oesophagus, stomach or intestine
• increased tension in the muscles, shaking and joint pain
• confusion, agitation, depression, anxiety, changes in your
mood or thoughts, drowsiness, sleeplessness, dizziness and
headache, tingling or numbness, change of the sense of
taste, loss of appetite, weight loss
• inflammation and infections of the sinuses, flu symptoms,
sore throat, runny and itchy nose
• non-cancerous growths of the skin and 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, fever, discomfort, lethargy,
weakness and swelling of the gums.
Side effects in children
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 nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: 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.
Do not use this medicine after the expiry date, which is stated
on the carton, blister and bottle after “EXP”. The expiry date
refers to the last day of that month.
Blisters: Store below 25°C. Store in the original container in
order to protect from moisture.
Bottles: Store below 25°C. Store in the original container in
order to protect from moisture. Use within 90 days of opening.
Once open keep bottle tightly closed.
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 to
protect the environment.

6. Contents of the pack and other information

What Mycophenolate Mofetil contains
The active substance is mycophenolate mofetil. Each filmcoated tablet contains 500 mg mycophenolate mofetil.
The other ingredients are: Tablet core: cellulose,
microcrystalline; maize starch, pregelatinised; povidone (K-30);
silica, colloidal anhydrous; magnesium stearate; sodium
laurilsulfate; croscarmellose sodium. Tablet coating: polyvinyl
alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b),
iron oxide red (E172), iron oxide yellow (E172).
What Mycophenolate Mofetil looks like and contents of
the pack
Your medicine is in the form of a film-coated tablet.
Mycophenolate Mofetil 500 mg Film-coated Tablets are light
pink coloured, oval-shaped tablet engraved with “MYLAN” on
one side of the tablet and “472” on the other side.
Mycophenolate Mofetil 500 mg Film-coated Tablets are
available in blisters packs and bottles of 20, 50, 60, 120, 150,
180, 300, 450, 500 film-coated tablets and perforated blister
packs of 20x1, 50x1, 60x1, 120x1, 150x1, 180x1, 300x1, 450x1,
500x1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Delpharm Lille S.A.S, Z.I. de Roubaix Est – Rue de Toufflers,
59 390 LYS-LEZ-LANNOY
France
This leaflet was last revised in 01/2016.
Other sources of information
Detailed information on this medicine is available on the web
site of Medicines and Healthcare Products Regulatory Agency.

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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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