PACKAGE LEAFLET: INFORMATION FOR THE USER

Mometil 500mg film-coated tablets

Mycophenolate mofetil

Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    WHAT MOMETIL IS AND WHAT IT IS USED FOR

Mometil contains the active ingredient mycophenolate mofetil which is one group of drugs known as immunosuppressant agents. Immunosuppressants are used to prevent rejection of transplanted organs like kidney, heart or liver and work by stopping your immune system from reacting to the transplanted organ

Mometil may be used together with other medicines known as ciclosporin and corticosteroids

2.    BEFORE YOU TAKE MOMETIL Do not take Mometil:

-    if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Mometil (listed in ‘FURTHER INFORMATION’)

-    if you breast-feeding

Take special care with Mometil:

Tell your doctor if any of the following applies to you:

-    if you think you may have an infection (signs may include fever, chills, local inflammation, sore throat or ulcers in the mouth, but there could be other symptoms), any evidence of unexpected bruising or any unexpected bleeding.

-    if you are suffering or have suffered from problems with your digestive system (such as ulcers or bleeding).

Mometil reduces your body’s defence mechanism. Because of this, there is an increased risk of skin cancer. Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may interfere with Mometil.

If you are taking any of the medicines listed below talk to your doctor before you start taking Mometil:

•    antacids - a class of medicines for indigestion or heartburn

•    azathioprine - is a drug used to suppress the body’s own defence system

•    cholestyramine (used to treat patients with high cholesterol)

•    other immunosuppressant

•    phosphate binders - used in patients with chronic renal failure to reduce the absorption of phosphate

•    rifampicin - an antibiotic used treat infections

•    vaccinations - as they may not be as effective as normal. Vaccination with live vaccines should be avoided.

Taking Mometil with food and drink

Taking food and drink has no influence on your treatment with Mometil

Pregnancy and breast-feeding

Do not take Mometil if you are breastfeeding.

You must not use mycophenolate during pregnancy unless clearly indicated by your doctor. Your doctor should advise you about using contraception before taking Mometil, whilst taking mycophenolate, and for six weeks after you have stopped taking Mometil. This is because mycophenolate may cause damage, including problems with development of the ears, to your unborn baby. Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.

Driving and using machines

Mometil has not been shown to impair your ability to drive or operate machinery

3. HOW TO TAKE MOMETIL

Always take Mometil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is as follows:

Kidney Transplant

Adults:

The first dose will be given within 72 hours after the transplant operation. The recommended daily dose is 4 tablets (2 g of the active ingredient) taken as 2 separate doses. This means taking 2 tablets in the morning 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 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 6 tablets (3 g of the active ingredient) taken as 2 separate doses. This means taking 3 tablets in the morning then 3 tablets in the evening.

Children:

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

Liver Transplant

Adults:

The first dose of oral Mometil 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. This means taking 3 tablets in the morning then 3 tablets in the evening.

Children:

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

Method and route of administration

The tablets should be swallowed whole with a glass of water.

Do not break or crush them.

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

If you take more Mometil than you should

Never take more than the recommended dose each day. If you or someone else swallows several of these tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.

If you forget to take Mometil

If you forget to take your medicine at any time, take it as soon as you remember unless it is almost time for your next dose then go on as before. Do not take a double dose to make up for a forgotten dose

If you stop taking Mometil

Always take Mometil exactly as your doctor has told you. Never stop taking your medicine or change the dose yourself, however well you feel unless you have discussed this with your doctor first. This is important to ensure your transplanted organ keeps working properly

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Mometil can cause side effects, although not everybody gets them.

Some of the more usual problems are diarrhoea, fewer white cells and/or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to monitor any changes in the number of your blood cells or changes in the levels of any of the substances carried in your blood, e.g. sugar, fat, cholesterol. Children may be more likely than adults to have side effects such as diarrhoea, infections, fewer white cells and fewer red cells in the blood

Mometil reduces your body’s own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver. Consequently your body will not be as good as normal at fighting infections. So if you are taking Mometil you may therefore catch more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract. As can happen in patients taking this type of medicine, a very small number of Mometil patients have developed cancer of the lymphoid tissues and skin.

General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioedema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/muscle, pain on passing urine), headache, flu symptoms and swelling.

Other unwanted effects may include:

Disorders of the skin such as acne, cold sores, shingles, skin growth, hair loss, rash, itching.

Urinary disorders such as kidney problems or the urgent need to pass urine.

Disorders of the digestive system and mouth such as constipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence swelling of the gums and mouth ulcers.

Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.

Metabolic, blood and vascular disorders such as weight loss, gout, high blood sugar, bleeding, bruises, change in blood pressure, abnormal heart beat and dilation of blood vessels may be seen.

Disorders of the lungs such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/chest cavity, sinus problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

However, do not stop taking your medicine unless you have discussed this with your doctor first.

5. HOW TO STORE MOMETIL

Keep out of the reach and sight of children.

Do not use Mometil after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

There are no special storage precautions for mycophenolate tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Mometil contains

The active substance is Mycophenolate mofetil

The other ingredients are:

Tablet core:

microcrystalline cellulose povidone K-90 croscarmellose sodium magnesium stearate silica collodial anhydrous

Tablet coating:

hypromellose

hydroxypropyl cellulose

titanium dioxide (E171)

macrogol 400

iron oxide yellow (E172)

iron oxide red (E172)

indigo carmine aluminium lake (E132)

What Mometil looks like and contents of the pack

Mometil are supplied as violet coloured caplet shaped film-coated tablets in blisters containing 50 or 150 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Eurogenus Farmaceutica Sociedade Unipessoal Lda Rua Alto do Montijo, 13 - 2° Dt°

2790-012 Portela Carnaxide Portugal

Manufacturer

Sofarimex - Industria Quimica e Farmaceutica, Lda Av. Das Industrias,

Alto de Colaride,

Agualva,

2735-213 Cacem Portugal

and

Monteresearch Via IV Novembre 94,

20021 Bollate (MI)

Italy

This medical product is authorised in the Member States of the EEA under the following names:

UK: Mometil 500 mg Film-coated tablet

CZ: Mometil 500 mg EE: Mometil

HU: Mometil 500 mg Filmtabletta LT: Mometil 500mg Plevele dengtos tabletes LV: Mometil 500 mg apvalkotas tabletes PL: Mometil

RO: Mometil 500 mg Comprimate filmate This leaflet was last approved on 01/2010