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MYCOPHENOLATE MOFETIL SANDOZ 250 MG CAPSULES HARD

Active substance(s): MYCOPHENOLATE MOFETIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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MYCOPHENOLATE MOFETIL SANDOZ 250 MG CAPSULES, HARD
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 Capsules are and what they are used for
2. What you need to know before you take Mycophenolate Capsules
3. How to take Mycophenolate Capsules
4. Possible side effects
5. How to store Mycophenolate Capsules
6. Contents of the pack and other information

1. What Mycophenolate Capsules are and what they are used for

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

2. What you need to know before you take Mycophenolate Capsules

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 Mycophenolate Capsules if:
• 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 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 Mycophenolate Capsules.

Warnings and precautions
Talk to your doctor straight away before taking Mycophenolate Capsules:
• 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 Capsules.
If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Mycophenolate
Capsules.
The effect of sunlight
Mycophenolate Capsules 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 Capsules
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 Capsules can affect the way some other medicines work. Also other medicines can affect the way
Mycophenolate Capsules works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start
Mycophenolate Capsules:
• 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 Capsules, 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 Capsules and for at least 6 weeks after stopping
treatment. Men must not donate semen during treatment with Mycophenolate Capsules and for at least 90 days
after stopping treatment.
Mycophenolate Capsules with food and drink
Taking food and drink has no effect on your treatment with Mycophenolate Capsules.
Pregnancy, contraception and breast-feeding

Contraception in women taking Mycophenolate Capsules
If you are a woman who could become pregnant, you must always use two effective methods of contraception with
Mycophenolate Capsules. This includes:
• Before you start taking Mycophenolate Capsules
• During your entire treatment with Mycophenolate Capsules
• For 6 weeks after you stop taking Mycophenolate Capsules.

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

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 8 capsules (2 g of the medicine) taken as 2 separate doses.
• Take 4 capsules in the morning and then 4 capsules in the evening.

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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 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.

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 medicines.
• 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.
Children
• There is no information for the use of mycophenolate mofetil in children with a liver transplant.
Taking the medicine
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 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 Capsules 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 accidentally takes your medicine. Take the medicine pack with you.
If you forget to take Mycophenolate Capsules
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 Capsules
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 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.

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
• 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.

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 via 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 Capsules

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, on the blister or on the container after
EXP. The expiry date refers to the last day of that month.
After first opening of the container: use within 2 months.
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 you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Mycophenolate Capsules contains
• The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.
The other ingredients in the capsule content are pregelatinised maize starch, croscarmellose sodium, povidone
(K-90F) magnesium stearate.
• The capsule shell consists of gelatine, red iron oxide (E172), yellow iron oxide(E172), titanium
dioxide (E171), indigo carmine (E132)
What Mycophenolate Capsules look like and contents of the pack
Hard gelatin capsules (size 1) with blue opaque cap and orange opaque body
PVC/PE/PVDC/Aluminium blister: 50, 100 and 300 capsules
HDPE container: 250 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or

Lek Pharmaceuticals d.d., Verovśkova 57, 1526 Ljubljana, Slovenia or
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria or

Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia.
This leaflet is 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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