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Package leaflet: Information for the user

Mycophenolate Mofetil 250 mg 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 further questions, please ask your doctor,pharmacist or nurse.

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Mycophenolate Mofetil Capsules is and what it is used for

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

3.    How to take Mycophenolate Mofetil Capsules

4.    Possible side effects

5.    How to store Mycophenolate Mofetil Capsules

6.    Contents of the pack and other information

1. What Mycophenolate Mofetil Capsules is and what it is used for

Immunosuppressant.

Mycophenolate Mofetil capsules are used to prevent your body rejecting a transplanted kidney, heart or liver.

Mycophenolate Mofetil capsules may be used together with other medicines known as ciclosporin and corticosteroids.

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

Do not take Mycophenolate Mofetil Capsules:

•    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 breast-feeding.

Warnings and precautions

Talk to your doctor straight away before taking Mycophenolate Mofetil if:

•    you have a sign of infection such as a fever or sore throat

•    you have any unexpected bruising or bleeding

•    you have ever had a problem with your digestive system such as a stomach ulcer

•    you are planning to become pregnant or if you get pregnant while taking Mycophenolate Mofetil.

If any of the above apply to you (or you are not sure), talk to your doctor 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 Capsules:

Please tell your doctor or pharmacist if you are taking or have recently taken, 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 your doctor or pharmacist if you are taking any of the following medicines before you start Mycophenolate Mofetil:

•    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, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.

Mycophenolate Mofetil Capsules with food and drink

Taking food and drink has no influence on your treatment with mycophenolate mofetil.

Pregnancy, contraception and breast-feeding:

Pregnancy

•    If you are pregnant, do not take Mycophenolate Mofetil This is because Mycophenolate Mofetil may cause miscarriage or damage to your unborn baby (affecting development of ears for example).

- In certain situations, you and your doctor may decide that the benefits of taking Mycophenolate Mofetil for your health are more important than the possible risks to your unborn baby.

•    If you plan to become pregnant, talk to your doctor first. Your doctor will talk to you about other medicines you can take to prevent rejection of your transplant organ.

•    If you think you may be pregnant tell your doctor straight away.

However, keep taking Mycophenolate Mofetil until you see him or her.

If you are able to become pregnant, you must have a pregnancy test before you start Mycophenolate Mofetil. You can only start Mycophenolate Mofetil if the test is negative.

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

You must always use an effective method 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.

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

not likely to affect you being able to drive or

use any tools or machines.

3. How to take Mycophenolate Mofetil Capsules

Always take this medicine exactly as your doctor or pharmacist 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 will be given within 72 hours after the transplant operation. The recommended daily dose is 8 capsules (2 g of the active ingredient) taken as 2 separate doses. This means taking 4 capsules in the morning then 4 capsules 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 body surface area (height and weight). The recommended dose is 600 mg/m² taken twice a day.

Heart Transplant

Adults:

The first dose will be given within 5 days following the transplant operation. The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses. This means taking 6 capsules in the morning then 6 capsules in the evening.

L

Children:

No data are available to recommend the use of Mycophenolate Mofetil in children who have received a heart transplant.

Liver Transplant

Adults:

The first dose of oral Mycophenolate Mofetil Capsules 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 12 capsules (3 g of the active ingredient) taken as 2 separate doses. This means taking 6 capsules in the morning then 6 capsules in the evening. Children:

No data are available to recommend the use of Mycophenolate Mofetil in children who have received a liver transplant.

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.

Method and Route of Administration

•    Swallow your capsules whole with a glass of water.

•    Do not break or crush them and do not take any capsules that have broken or split open.

•    Avoid contact with any powder that spills out from damaged capsules.

•    If a capsule breaks open accidentally, wash any powder from your skin with soap and water. If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.

•    Treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplanted organ.

If you take more Mycophenolate Mofetil Capsules than you should

If you take more mycophenolate mofetil capsules 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.

If you forget to take Mycophenolate Mofetil 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.

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

If you stop taking Mycophenolate Mofetil Capsules

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 medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can have 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.

For Malta- ADR Reporting ADR Reporting Website:

www.medicinesauthority.gov.mt/adrportal

5. How to store Mycophenolate Mofetil 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 label or carton after EXP. The expiry date refers to the last day of that month.

•    Store below 30^oC.

•    Do not use this medicine if you notice any visible signs of deterioration.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Mycophenolate Mofetil Capsules contains:

The active substance is Mycophenolate Mofetil. Each capsule contains 250 mg of Mycophenolate Mofetil.

The other ingredients are: cellulose microcrystalline, hydroxy propyl cellulose, povidone K 90, croscarmellose sodium, talc & magnesium stearate.

Capsule Shell composition: Gelatin, sodium lauryl sulfate, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), FD & C Blue 2 (E132)

Black Ink composition: Shellac, Black iron oxide.

What Mycophenolate Mofetil Capsules looks like and content of the pack:

Mycophenolate Mofetil 250 mg capsules are light blue/peach size ‘1’ hard gelatin capsules with imprinting with ‘MMF’ on cap and ‘250’ on body, containing white to off white powder.

Mycophenolate Mofetil 250 mg Capsules are available in blister in packs of 100 and 300’ capsules.

Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4HF, United Kingdom

Manufacturer:

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4HF, United Kingdom

Wessling Hungray Limited 1047 Budapest, Foti ut 56.

Hungary

The leaflet was last revised in 05/2015.