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MYCOPHENOLATE MOFETIL LEK 500MG FILM-COATED TABLETS

Active substance(s): MYCOPHENOLATE MOFETIL

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Lek Pharmaceuticals d.d
PL 16220/0006
Mycophenolate mofetil Lek 500 mg Filmcoated Tablets

Page 1

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Mycophenolate mofetil Lek 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 of the 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 Lek is and what it is used for
2. What you need to know before you take Mycophenolate mofetil Lek
3. How to take Mycophenolate mofetil Lek
4. Possible side effects
5. How to store Mycophenolate mofetil Lek
6. Contents of the pack and other information
1.

What Mycophenolate mofetil Lek is and what it is used for

Mycophenolate mofetil Lek contains mycophenolate mofetil. This belongs to a group of
medicines called “immunosuppressants”.
Mycophenolate mofetil Lek is used to prevent your body rejecting a transplanted organ:
 A kidney, heart or liver.
Mycophenolate mofetil Lek should be used together with other medicines:
 Ciclosporin and corticosteroids.
2.

What you need to know before you take Mycophenolate mofetil Lek

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.

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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 Mycophenolate mofetil Lek:
 If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of
the other ingredients of this medicine (listed in section 6).
 If you are a woman who could be pregnant and you have not provided a negative
pregnancy test before your first prescription as mycophenolate causes birth defects and
miscarriage.
 If you are pregnant or planning to become pregnant or think you may be pregnant
 If you are not using effective contraception (see Pregnancy, contraception and breastfeeding).
 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 Mycophenolate mofetil Lek.
Warnings and precautions
Talk to your doctor straight away before taking Mycophenolate mofetil Lek:
 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 taking
Mycophenolate mofetil Lek.
If any of the above apply to you (or you are not sure), talk to your doctor straight away
before taking Mycophenolate mofetil Lek.
The effect of sunlight
Mycophenolate mofetil Lek 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 clothingwhich also covers your head, neck, arms and legs
 using a sunscreen with a high protection factor.
Other medicines and Mycophenolate mofetil Lek:
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 Lek can affect the way some other
medicines work. Also other medicines can affect the way Mycophenolate mofetil Lek works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines
before you start Mycophenolate mofetil Lek:

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azathioprine or other medicines which 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.

Vaccines
If you need to have a vaccine (a live vaccine) while taking Mycophenolate mofetil Lek, 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 Mycophenolate mofetil Lek and for at least
6 weeks after stopping treatment. Men must not donate semen during treatment with
Mycophenolate mofetil Lek and for at least 90 days after stopping treatment.
Mycophenolate mofetil Lek with food and drink
Taking food and drink has no effect on your treatment with Mycophenolate mofetil Lek.
.

Pregnancy, contraception and breast-feeding
Contraception in women taking Mycophenolate mofetil Lek
If you are a woman who could become pregnant you must always use two effective methods
of contraception with Mycophenolate mofetil Lek. This includes:




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

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).

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Mycophenolate mofetil Lek 500 mg Filmcoated Tablets







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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 Lek
You must always use condoms during treatment and for 90 days after you stop taking
Mycophenolate mofetil Lek.
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 Lek 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

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PL 16220/0006
Mycophenolate mofetil Lek 500 mg Filmcoated Tablets

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Do not take Mycophenolate mofetil Lek 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.
3. How to take Mycophenolate mofetil Lek
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 you from rejecting
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 themedicine ) 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 mycophenolate mofetil in children with a heart
transplant.
Liver transplant
Adults:

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PL 16220/0006
Mycophenolate mofetil Lek 500 mg Filmcoated Tablets





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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 medicines.
The daily dose is 6 tablets (3 g of themedicine ) 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 Mycophenolate mofetil Lek 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 Mycophenolate mofetil Lek than you should
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight
away. Also do this if someone else accidentaly takes your medicine. Take the medicine pack
with you.
If you forget to take Mycophenolate mofetil Lek
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 Lek:
Do not stop taking this medicine 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, 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:
• 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

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Lek Pharmaceuticals d.d
PL 16220/0006
Mycophenolate mofetil Lek 500 mg Filmcoated Tablets

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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
• the amount in your blood of things like sugar, fat or cholesterol.
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
Mycophenolate mofetil 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 mycophenolate mofetil patients 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, pain on passing urine), 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:
• kidney problems or the urgent need to pass water (urine).
Digestive system and mouth problems such as:
• swelling of the gums and mouth ulcers,
• inflammation of the pancreas, colon or stomach,
• gut problems including bleeding, liver problems,
• 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, unusual heartbeat, widening of blood vessels.

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Lek Pharmaceuticals d.d
PL 16220/0006
Mycophenolate mofetil Lek 500 mg Filmcoated Tablets

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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 pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly Yellow Card Scheme:
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 Lek

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 or the label
after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Lek contains
The active substance is mycophenolate mofetil. Each film-coated tablet contains 500 mg
of mycophenolate mofetil.
The other ingredients are:
Core content:
Cellulose microcrystalline, povidone, talc, magnesium stearate, croscarmellose sodium.
Coating content:
Hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol(400), iron
oxide black (E172), iron oxide red (E172).
What Mycophenolate mofetil Lek looks like and contents of the pack

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Lek Pharmaceuticals d.d
PL 16220/0006
Mycophenolate mofetil Lek 500 mg Filmcoated Tablets

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PVC/PE/PVdC/Al blister
Pack sizes: 50, 150 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Lek Pharmaceuticals d.d.
Verovśkova 57
1526 Ljubljana
Slovenia
Manufacturer
Lek Pharmaceuticals d.d., Verovśkova 57, 1526 Ljubljana, Slovenia or
LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland or
LEK S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany

This leaflet was last revised in 01/2016.

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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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