Myfenax 500 mg film-coated tablets

Myfenax is a medicine that is used to suppress immune activity.

Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver. It is used in combination with other medicines with a similar function (i.e. ciclosporin and corticosteroids).

Do not take Myfenax

• if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Myfenax. if you are breast-feeding.

Take special care with Myfenax

You should inform your doctor immediately:

• if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
• if you have or ever have had any problems with your digestive system, e.g. stomach ulcers.
• if you are planning to become pregnant, or if you fall pregnant while taking Myfenax.

Myfenax 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 ultra violet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax:

• Are you taking any medicines containing: azathioprine or other immunosuppressive agents (which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic kidney failure to reduce the absorption of phosphate), or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
• Do you need to receive vaccines (live vaccines)? Your doctor will have to advise you what is indicated for you

Taking Myfenax with food and drink

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

Pregnancy and breast-feeding

Use of Myfenax 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 benefit of taking Myfenax for your health is more important than the possible risks to your unborn baby.

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

Do not take Myfenax 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 Myfenax
• During the entire treatment with Myfenax
• For 6 weeks after you stop taking Myfenax

You should talk to your doctor about the most suitable method 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 Myfenax.

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 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.

Driving and using machines
Myfenax has not been shown to impair your ability to drive or operate machines.

Always take Myfenax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual way to take Myfenax 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 and adolescents:
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/m 2 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 and adolescents:
No data are available to recommend the use of Myfenax in children and adolescents who have received a heart transplant.

Liver Transplant

Adults:
The first dose of oral Myfenax will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines. 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 and adolescents:
No data are available to recommend the use of Myfenax in children and adolescents 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 you as long as you need immunosuppression to prevent your body from rejecting your transplanted organ.

If you take more Myfenaxthan you should
It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more tablets than you have been told to take or if you think a child has swallowed any.

If you forget to take Myfenax

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 Myfenax

Do not stop taking Myfenax because you feel better. It is important to take the medicine for as long as the doctor has told you to. Stopping your treatment with Myfenax 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.

Like all medicines, Myfenax can have side effects, although not everybody gets them.

Very common side effects likely to affect more than 1 in 10 people:

• Diarrhoea, vomiting, feeling sick
• Decrease in normal amounts of different blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness
• Bacterial, fungal and viral infections of the digestive and urinary tract, cold sores and shingles

Common side effects likely to affect less than 1 in 10, but more than 1 in 100 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
• Kidney problems with increased levels of urea
• Disorders of the digestive system such as constipation, indigestion, flatulence, belching, swelling of the gums, 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
• Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss
• Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose
• Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina
• Changes in blood pressure, faster heart beat, dilation of blood vessels
• Fluid retention in the body, fever, discomfort, lethargy and weakness
• Inflammation of the liver, yellowing of the skin and whites of the eyes

Uncommon side effects likely to affect less than 1 in 100 but more than 1 in 1000 people

• Proliferation of the lymphatic tissue, including malignant tumours
• Inflammation or infections of the heart and its valves and of the membrane that covers the brain and spinal cord

Other side effects that have been reported where frequency has not been established

• Hypersensitivity (allergic) reactions

Do not stop taking your medicine unless you have discussed this with your doctor first.

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

Keep out of the reach and sight of children.

Do not use Myfenax after the expiry date as stated on the blister and carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

What Myfenax contains:
The active substance is 500 mg mycophenolate mofetil.

The other ingredients are:

Tablet core:
Microcrystalline cellulose
Povidone K-30
Magnesium stearate
Croscarmellose sodium

Tablet coat:
Hypromellose (HPMC 2910)
Titanium dioxide (E171)
Macrogol (PEG 400)
Talc
Indigo carmine aluminium lake (E132)
Iron oxide black (E172)
Iron oxide red (E172)

What Myfenax looks like and contents of the pack

Film-coated tablets:
Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.

Myfenax 500 mg film-coated tablets is available in PVC/PVdC ? aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands

Manufacturers

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13.
Debrecen H-4042
Hungary

Teva Pharmaceutical Works Private Limited Company
H-2100 Gödöll-, Táncsics Mihály ut 82
Hungary

Teva UK Ltd
Brampton Road
Hampden Park
Eastbourne, East Sussex
BN22 9AG, UK

Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

TEVA Santé SA
Rue Bellocier
89107 Sens
France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A.AG TelTél 32 38.20.73.73 LuxembourgLuxemburg Teva Pharma Belgium N.V.S.A.AG TelTél 32 38.20.73.73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt., Tel 36 1 288 6400

eská republika Teva Pharmaceuticals CR, s.r.o Telephone 420 606 763 892 Malta Teva .. 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB Telephone 46 42 12 11 00

Österreich Teva GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filial Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o Telephone 48 22 345 93 00

España Teva Pharma, S.L.U. Telephone 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos, Lda. Telephone 351 214 235 910

France Teva Santé Telephone 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Telephone 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Telephone 353 42 9395892. Slovenija Teva UK Limited Telephone 44 1323 501 111.

Ísland Teva UK Limited Telephone 44 1323 501 111. Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Telephone 421 2 5726 7911

Italia Teva Italia S.r.l. Telephone 39 0289179805 SuomiFinland Teva Sweden AB Telephone 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Telephone 46 42 12 11 00

Latvija UAB Sicor Biotech Latvian Affiliate Telephone 371 67784980. United Kingdom Teva UK Limited Telephone 44 1323 501 111.

Lietuva
UAB ?Sicor Biotech?
Telephone: +370 5 266 02 03

This leaflet was last approved in {MM/YYYY}.