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Myfenax (mycophenolate mofetil) – Package leaflet - L04AA06

Updated on site: 08-Oct-2017

Medication nameMyfenax
ATC CodeL04AA06
Substancemycophenolate mofetil
ManufacturerTeva B.V.

Package leaflet: Information for the user

Myfenax 250 mg hard capsules

Mycophenolate mofetil

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Myfenax is and what it is used for

2.What you need to know before you take Myfenax

3.How to take Myfenax

4.Possible side effects

5.How to store Myfenax

6.Contents of the pack and other information

1.What Myfenax is and what it is used for

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

The active substance in this medicine is called mycophenolate mofetil.

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).

2.What you need to know before you take Myfenax

WARNING

Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.

Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy, contraception and breast-feeding”.

Do not take Myfenax,

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

if you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.

if you are pregnant or planning to become pregnant or think you may be pregnant.

if you are not using effective contraception (see Pregnancy, contraception and breast-feeding).

if you are breast-feeding.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Myfenax.

Warnings and precautions

Talk to 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 get 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 ultraviolet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.

You must not donate blood during treatment with Myfenax and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Myfenax and for at least 90°days after stopping treatment.

Children and adolescents

Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.

Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.

Myfenax should not be used at all in children under 2 years old.

Other medicines and Myfenax

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 or proton pump inhibitors (used for acid problem in your stomach such as indigestion), 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.

Pregnancy, contraception and breast-feeding

Contraception in women taking Myfenax

If you are a woman who could become pregnant you must always use two effective methods of contraception with Myfenax. This includes:

Before you start taking Myfenax

During your entire treatment with Myfenax

For 6°weeks after you stop taking Myfenax.

Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.

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.

Contraception in men taking Myfenax

You must always use condoms during treatment and for 90°days after you stop taking Myfenax. If you are planning to have a child, your doctor will talk to you about the risks and the alternative treatments you can take to prevent rejection of your transplant organ.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:

You plan to become pregnant.

You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.

You have sex without using an effective method of contraception.

If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking Myfenax until you see him or her.

Pregnancy

Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-27%) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.

Breast-feeding

Do not take Myfenax if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.

Driving and using machines

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

3.How to take Myfenax

Always take Myfenax exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your treatment is started and monitored by a doctor who is specialised in transplants.

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 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 and adolescents (aged 2 to 18)

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.

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 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.

Method and route of administration

Swallow your capsules whole with a glass of water. You can take them with or without food. 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 you as long as you need immunosuppression to prevent your body from rejecting your transplanted organ.

If you take more Myfenax than you should

It is important not to take too many capsules. Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more capsules 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 medicine, ask your doctor or pharmacist.

4.Possible side effects

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

Very common (may 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 (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

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 (may affect up to 1 in 100 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

Not known (frequency cannot be estimated from the available data)

Hypersensitivity (allergic) reactions

Shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Myfenax

Keep this medicine out of the sight and reach 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Myfenax contains

The active substance is mycophenolate mofetil.

Each capsule contains 250 mg mycophenolate mofetil.

The other ingredients are: Capsule content Pregelatinised maize starch Povidone K-30 Croscarmellose sodium Magnesium stearate Capsule shells

Cap

Indigo carmine (E132) Titanium dioxide (E171) Gelatin

Body

Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin

Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide

What Myfenax looks like and contents of the pack

Hard capsules

Body: caramel opaque, printed ‘250’ axially in black ink.

Cap: light blue opaque printed ‘M’ axially in black ink.

Myfenax 250 mg hard capsules are available in PVC/PVdC-aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturers

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13.

Debrecen H-4042

Hungary

Teva Operations Poland Sp. Z.o.o.

Mogilska 80 Str.

31-546 Krakow

Poland

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

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

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./AG

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Telephone: +370 5 266 02 03

България

Luxembourg/Luxemburg

Teва Фармасютикълс България ЕООД

Teva Pharma Belgium N.V./S.A./AG

Телефон: +359 2 489 95 82

Belgique/Belgien

 

Tel/Tél: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o

Teva Gyógyszergyár Zrt.

Telephone: +420 251 007 111

Tel: +36 1 288 6400

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321 740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: +49 731 402 08

Tel: +31 (0) 800 0228400

Eesti

Norge

Teva Eesti

Teva Norway AS

esindus UAB Sicor Biotech Eesti filiaal

Tlf: +47 66 77 55 90

Tel: +372 661 0801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 (0) 1 970070

España

Polska

Teva Pharma, S.L.U.

Teva Pharmaceuticals Polska Sp. z o.o

Telephone: +34 91 387 32 80

Telephone: +48 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos, Lda.

Telephone: +33 1 55 91 7800

Telephone: +351 21 476 75 50

Hrvatska

România

Pliva Hrvatska d.o.o.

Teva Pharmaceuticals S.R.L

Tel: +385 1 37 20 000

Telephone: +4021 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Telephone: +353 (0)51 321 740

Tel: +386 1 5890 390

Ísland

Slovenská republika

Medical ehf.

TEVA Pharmaceuticals Slovakia s.r.o.

Sími: +354 534 3500

Telephone: +421 2 5726 7911

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Telephone: +39 028917981

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

Τηλ: +30 210 72 79 099

Telephone: +46 (0) 42 12 11 00

Latvija

United Kingdom

Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67323666

Telephone: +44 1977628500

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.

Package leaflet: Information for the user

Myfenax 500mg film-coated tablets

Mycophenolate mofetil

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Myfenax is and what it is used for

2.What you need to know before you take Myfenax

3.How to take Myfenax

4.Possible side effects

5.How to store Myfenax

6.Contents of the pack and other information

1. What Myfenax is and what it is used for

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

The active substance in this medicine is called mycophenolate mofetil.

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).

2. What you need to know before you take Myfenax

WARNING

Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.

Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.

If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy, contraception and breast-feeding”.

Do not take Myfenax,

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

if you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.

if you are pregnant or planning to become pregnant or think you may be pregnant.

if you are not using effective contraception (see Pregnancy, contraception and breast-feeding).

if you are breast-feeding.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Myfenax.

Warnings and precautions

Talk to 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 get 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 ultraviolet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.

You must not donate blood during treatment with Myfenax and for at least 6°weeks after stopping treatment. Men must not donate semen during treatment with Myfenax and for at least 90°days after stopping treatment.

Children and adolescents

Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.

Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.

Myfenax should not be used at all in children under 2°years old.

Other medicines and Myfenax

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 or proton pump inhibitors (used for acid problem in your stomach such as indigestion), 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.

Pregnancy, contraception and breast-feeding

Contraception in women taking Myfenax

If you are a woman who could become pregnant you must always use two effective methods of contraception with Myfenax. This includes:

Before you start taking Myfenax

During your entire treatment with Myfenax

For 6°weeks after you stop taking Myfenax.

Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.

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.

Contraception in men taking Myfenax

You must always use condoms during treatment and for 90°days after you stop taking Myfenax. If you are planning to have a child, your doctor will talk to you about the risks and the alternative treatments you can take to prevent rejection of your transplant organ.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:

You plan to become pregnant.

You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.

You have sex without using an effective method of contraception.

If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking Myfenax until you see him or her.

Pregnancy

Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-27%) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.

Breast-feeding

Do not take Myfenax if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.

Driving and using machines

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

3. How to take Myfenax

Always take Myfenax exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your treatment is started and monitored by a doctor who is specialised in transplants.

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 (aged 2 to 18)

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.

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.

Method and route of administration

Swallow your tablets whole with a glass of water. You can take them with or without food. 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 Myfenax than 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common (may 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 (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

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 (may affect up to 1 in 100 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

Not known (frequency cannot be estimated from the available data)

Hypersensitivity (allergic) reactions

Shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Myfenax

Keep this medicine out of the sight and reach 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Myfenax contains

The active substance is mycophenolate mofetil.

Each tablet contains 500mg of 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 are 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 B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturers

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13.

Debrecen H-4042

Hungary

Teva Operations Poland Sp. Z.o.o.

Mogilska 80 Str.

31-546 Krakow

Poland

Teva UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG, UK

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

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

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./AG

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Telephone: +370 5 266 02 03

България

Luxembourg/Luxemburg

Teва Фармасютикълс България ЕООД

Teva Pharma Belgium N.V./S.A./AG

Телефон: +359 2 489 95 82

Belgique/Belgien

 

Tel/Tél: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o

Teva Gyógyszergyár Zrt.

Telephone: +420 251 007 111

Tel: +36 1 288 6400

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321 740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: +49 731 402 08

Tel: +31 (0) 800 0228 400

Eesti

Norge

Teva Eesti esindus UAB

Teva Norway AS

Sicor Biotech Eesti filiaal

Tlf: +47 66 77 55 90

Tel: +372 661 0801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 (0) 1 970070

España

Polska

Teva Pharma, S.L.U.

Teva Pharmaceuticals Polska Sp. z o.o

Telephone: +34 91 387 32 80

Telephone: +48 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos, Lda.

Telephone: +33 1 55 91 7800

Telephone: +351 21 476 75 50

Hrvatska

România

Pliva Hrvatska d.o.o.

Teva Pharmaceuticals S.R.L

Tel: +385 1 37 20 000

Telephone: +4021 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Telephone: +353 (0)51 321 740

Tel: +386 1 5890 390

Ísland

Slovenská republika

Medical ehf.

TEVA Pharmaceuticals Slovakia s.r.o.

Sími: +354 534 3500

Telephone: +421 2 5726 7911

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Telephone: +39 028917981

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

Τηλ: +30 210 72 79 099

Telephone: +46 (0) 42 12 11 00

Latvija

United Kingdom

Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67323666

Telephone: +44 1977628500

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.

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