PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Mycophenolate mofetil Hexal 500 mg Film-coated Tablets

Mycophenolate mofetil

What is in this leaflet

1.    What Mycophenolate is and what it is used for

2.    What you need to know before you take Mycophenolate

3.    How to take Mycophenolate

4.    Possible side effects

5.    How to store Mycophenolate

6.    Contents of the pack and other information

1.    What Mycophenolate is and what it is used for

Mycophenolate belongs to the class of drugs known as immunosuppressants. Mycophenolate tablets are used to prevent your body rejecting a transplanted kidney, heart or liver.

Mycophenolate is used together with other medicines known as ciclosporin and corticosteroids.

2.    What you need to know before you take Mycophenolate Do not take Mycophenolate if:

•    you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).

•    you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Mycophenolate if:

• you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.

•    you have, or ever have had any problems with your digestive system, e.g. stomach ulcers.

•    you are planning to become pregnant, or if you fall pregnant while taking Mycophenolate.

•    you suffer from an enzyme defect called ‘Lesch-Nyhan syndrome’ or ‘Kelley Seegmiller syndrome’.

•    Limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor. There is an increased risk of skin cancer because mycophenolate reduces your body’s defence mechanism.

Other medicines and Mycophenolate

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

Take care with the following medicines:

•    Azathioprine or tacrolimus or other immunosuppressive agents (which are sometimes given to patients after a transplant operation)

•    Colestyramine (used to treat patients with high blood cholesterol)

•    Rifampicin, ciprofloxacin or amoxicillin plus clavulanic acid (antibiotics)

•    Antacids or medicines called ‘proton pump inhibitors’ like omeprazole or pantoprazole (used treat diseases related to the acid in the stomach)

•    Phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate)

•    Aciclovir, ganciclovir (for viral infections)

•    Live vaccines should be avoided. Your doctor will have to advise you what is indicated for you.

Pregnancy and breast-feeding

Use of Mycophenolate during pregnancy may cause miscarriage or damage to your unborn baby (abnormal development of ears for example).

If you plan to become pregnant, discuss with your doctor alternative medicines to best prevent rejection of your transplanted organ. In certain situations, you and your doctor may decide that the benefits of taking Mycophenolate for your health are more important than the possible risks to your unborn baby.

If you become pregnant while taking Mycophenolate, do not stop taking it, but tell your doctor about your pregnancy as soon as possible.

Do not take Mycophenolate if you are:

•    Breast-feeding

•    Pregnant (unless your doctor clearly tells you)

Tell your doctor straight away if:

•    You think you may be pregnant

•    You are breast-feeding

•    You plan to start a family in the near future

You must always use an effective method of birth control:

•    Before you start taking Mycophenolate

•    During your entire treatment with Mycophenolate

•    For 6 weeks after you stop taking Mycophenolate

You should talk to your doctor about the most suitable methods for birth control for you based on your individual situation.

Women who are capable of becoming pregnant must have a negative pregnancy test BEFORE starting treatment with Mycophenolate

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 (bilateral salpingo-oophorectomy).

•    Your uterus has been surgically removed (hysterectomy).

•    You have premature failure of the ovaries, confirmed by a specialist gynaecologist.

•    You have been diagnosed with one of the following rare conditions that some patients are born with that make pregnancy impossible: the XY genotype, Turner’s syndrome or uterine agenesis.

•    You are a child/teenager who has not started having periods, and cannot become pregnant.

If you are a sexually active man it is recommended to use condoms during treatment, and for a total of 13 weeks after your last dose of Mycophenolate. In addition, your female partners are recommended to use highly effective contraception during your treatment and for a total of 13 weeks after the last dose of Mycophenolate.

Driving and using machines

Mycophenolate mofetil has not been shown to impair your ability to drive or operate machinery.

3. How to take Mycophenolate

Always take this medicine exactly as your doctor or pharmacist has told you. 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 and 2 tablets in the evening.

Children and adolescents (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 and 3 tablets in the evening.

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 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 and 3 tablets in the evening.

Children:

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

Method and route of administration

Swallow your tablets 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 Mycophenolate 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.

If you forget to take Mycophenolate

Do not worry, take it as soon as you remember.

If it is almost time to take the next dose, wait until then and continue with your usual schedule.

Do not double the dose to make up for the one missed.

If you stop taking Mycophenolate

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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects

If you notice one of the following serious side effects, talk to your doctor or go to a hospital immediately:

•    In case of any evidence of infection (e.g. fever, sore throat)

•    Unusual bruising or bleeding, includes vomiting blood or passing blood in your stools

•    Fits (convulsions)

•    Yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine (signs of inflamed liver).

•    Hypersensitivity reactions (anaphylaxis, angioedema): If you develop a swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty in breathing or swallowing, or extreme dizziness.

Other possible side effects

Elderly patients may generally be at increased risk of side effects.

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.

The following side effects are very common (may affect more than 1 in 10 people):

•    Fewer white cells and/or red cells or platelets in your blood. 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

•    Diarrhoea, feeling or being sick, abdominal pain

•    Cold sores, shingles

•    Urinary tract infections, urgent need to pass urine

The following side effects are common (may affect up to 1 in 10 people):

•    Infections of the brain, skin, mouth, stomach and intestines, and lungs:

Mycophenolate mofetil 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 mycophenolate mofetil you may therefore catch more infections than usual.

•    As can happen in patients taking this type of medicine, a very small number of mycophenolate mofetil patients have developed cancer of the lymphoid tissues and skin.

•    Infections, such as flu symptoms, vaginal thrush.

•    Metabolic and nutrition disorders, such as weight loss, loss of appetite, gout, high blood sugar, high blood fat and cholesterol.

•    Blood, cardiac and vascular disorders such as bleeding, bruises, increased level of white blood cells, change in blood pressure, abnormal heart beat and dilation of blood vessels.

•    Nervous system and psychiatric disorders such as convulsions, tremor, dizziness, numbness, muscle spasms, headache, anxiety, depression, confusion, agitation, drowsiness, changes in thinking or mood, insomnia.

•    Respiratory and thoracic disorders such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/chest cavity, sinus problems, runny or blocked nose (rhinitis), pharyngitis.

•    Gastrointestinal disorders such as constipation, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach or oesophagus, gastric ulcer, duodenal ulcer, liver problems, inflammation of the colon, inflammation of the abdominal cavity, flatulence, swelling of the gums, mouth ulcers and impaired taste.

•    Skin disorders such as acne, skin growth, hair loss, rash, itching.

•    Renal and urinary disorders such as kidney problems.

•    General disorders such as fever, chills, malaise, weakness, pain (such as chest, joint/muscle) and swelling.

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 the 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

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 protect the environment.

6. Contents of the pack and other information What Mycophenolate 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 looks like and contents of the pack

PVC/PE/PVdC/Al blister

Pack sizes: 30, 50, 100, 120, 150, 180, 250, 300 film-coated tablets.

HDPE bottle

Pack sizes: 30, 50, 100, 150, 300 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Manufacturer

Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or

LEK S.A., ul. Podlipie 16, 95-010 Strykow, 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 10/2013.