Package Leaflet: Information for the User

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.

Mycophenolate Mofetil 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

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 pregnant or breast-feeding.

Do not take this medicine if any of the above apply 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 experience any evidence of infection such as fever, or sore throat

•    if you have any unexpected bruising or bleeding

•    if you have ever had problems with your digestive system, such as 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 phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist straight away before taking Mycophenolate Mofetil.

Blood tests

Mycophenolate mofetil can affect the levels of blood cells and other substances in your blood (see section 4). Your doctor will monitor for any changes by performing regular blood tests while you are taking this medicine.

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 appropriate 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 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 infection 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.

Date: 18 FEB 2015

Vaccines

If you need to have a vaccine (a live vaccine) while taking Mycophenolate Mofetil, talk to your doctor first. Your doctor will have to advise you on what vaccines you can have. Mycophenolate Mofetil with food and drink Taking food and drink has no effect 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.

•    I f 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.

•    I f 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 breastfeeding. 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

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:

•    The first dose is given within 3 days of the transplant operation.

•    The recommended daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.

•    Take 2 tablets in the morning and then 2 tablets in the evening.

Use in 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 meters or "m²"). The recommended dose is 600 mg/m² taken twice a day.

Use in children below 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

•    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.

Date: 18 FEB 2015

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.

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 defense 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 different blood cells, which can 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.

Common side effects - may affect up to 1 in 10 people

•    inflammation of the liver, yellowing of the skin and whites of the eyes.

Uncommon - may affect up to 1 in 100 people:

•    severe reduction in the number of white blood cells, which makes infections more likely (agranulocytosis). Symptoms include high temperature and ulcers in the mouth and throat.

Not known (frequency cannot be estimated from the

available data):

•    wheezing 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, angioeodema)

•    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

•    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 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 side effects - may affect up to 1 in 10 people:

•    changes in different laboratory parameters, including increase in liver enzymes, renal parameters such

as creatinine, 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)

•    kidney problems with increased levels of urea

•    disorders of the digestive system such as constipation, indigestion, excessive wind, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding

•    convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain

Date: 18 FEB 2015

•    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 and gastrointestinal tract, flu symptoms, sore throat, runny and itchy nose

•    skin cancer or 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 heart beat, widening of blood vessels

•    fluid on lungs/chest cavity, gout

•    fluid retention in the body, fever, discomfort, lethargy, weakness and swelling of the gums

Uncommon - may affect up to 1 in 100 people:

•    proliferation of the lymphatic tissue, including malignant tumours

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 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 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 film-coated 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 lauril sulfate; 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 02/2015.

Other sources of information

Detailed information on this medicine is available on the web site of Medicines and Healthcare Products Regulatory Agency.

5029802

485029

Date: 18 FEB 2015