Package leaflet: Information for the patient

Mycot 250 mg Capsules

Mycophenolate mofetil

What is in this leaflet

1.    What Mycot 250 mg Capsules are and what they are used for

2.    What you need to know before you take Mycot 250 mg Capsules

3.    How to take Mycot 250 mg Capsules

4.    Possible side effects

5.    How to store Mycot 250 mg Capsules

6.    Contents of the pack and other information

1.    What Mycot 250 mg Capsules are and what they are used for

Mycophenolate mofetil belongs to the class of drugs known as immunosuppressants.

Mycot 250 mg Capsules are used to prevent your body rejecting a transplanted kidney, heart or liver.

Mycot 250 mg Capsules are used together with other medicines known as ciclosporin and corticosteroids.

2.    What you need to know before you take Mycot 250 mg Capsules Do not take Mycot 250 mg Capsules 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 Mycot 250 mg Capsules

•    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 Mycot 250 mg Capsules

•    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 Mycot 250 mg Capsules

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 Mycot 250 mg Capsules 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 Mycot 250 mg Capsules for your health are more important than the possible risks to your unborn baby.

If you become pregnant while taking Mycot 250 mg Capsules, do not stop taking it, but tell your doctor about your pregnancy as soon as possible.

Do not take Mycot 250 mg Capsules 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 Mycot 250 mg Capsules

•    During your entire treatment with Mycot 250 mg Capsules

•    For 6 weeks after you stop taking Mycot 250 mg Capsules

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 Mycot 250 mg Capsules.

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 Mycot 250 mg Capsules. 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 Mycot 250 mg Capsules.

Driving and using machines

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

3. How to take Mycot 250 mg 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. 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 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.

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 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.

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 open or split.

•    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 Mycot 250 mg Capsules than you should:

If you take more 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 Mycot 250 mg Capsules:

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 take a double dose to make up for the forgotten dose.

If you stop taking Mycot 250 mg 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 or pharmacist.

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.

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

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 dilatation 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 Mycot 250 mg 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 Mycot 250 mg Capsules contain

-    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 Mycot 250 mg 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: 100 and 300 capsules.

HDPE container: 250 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and Manufacturer Marketing authorization holder:

Rowex Ltd.

Newtown Bantry Co. Cork Republic of Ireland

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

or

LEK S.A.

Ul. Podlipie 16 95 010 Strykow Poland

or

LEK S.A.

ul. Domaniewska 50 C, 02-672 Warsaw Poland

Or

Lek Pharmaceuticals d.d. Verovskova 57 1526 Ljubljana Slovenia

Or

Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria

Or

Lek Pharmaceuticals d.d. Trimlini 2D 9220 Lendava Slovenia