Mykofenolatmofetil Actavis

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Package leaflet: Information for the user

Mykofenolatmofetil Actavis 500 mg 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Mykofenolatmofetil Actavis is and what it is used for

2. What you need to know before you take Mykofenolatmofetil Actavis

3. How to take Mykofenolatmofetil Actavis

4. Possible side effects

5. How to store Mykofenolatmofetil Actavis

6. Contents of the pack and other information

1. What Mykofenolatmofetil Actavisis and what it is used for

Mykofenolatmofetil Actavis contains mycophenolate mofetil.

- This belongs to a group of medicines called “immunosuppressants”.

Mykofenolatmofetil Actavis is used to prevent your body rejecting a transplanted organ.

- A kidney, heart or liver.

Mykofenolatmofetil Actavis is used together with other medicines:

- ciclosporin and corticosteroids.

2. What you need to know before you take Mykofenolatmofetil Actavis

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 Mykofenolatmofetil Actavis:

- if you are allergic 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 Mykofenolatmofetil Actavis.

Warnings and precautions:

Talk to your doctor before taking Mykofenolatmofetil Actavis:

- if you have a sign of infection such as a fever or sore throat you have any unexpected bruising or bleeding.

- if you have ever had a problem with your digestive system such as a stomach ulcer.

- if you are planning to become pregnant or if you get pregnant while taking Mykofenolatmofetil Actavis.

- if you have a rare hereditary deficiency of the enzyme hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome, as Mykofenolatmofetil Actavis should be avoided.

If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Mykofenolatmofetil Actavis.

The effect of sunlight

Mykofenolatmofetil Actavis reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:

- wearing protective clothing which also covers your head, neck, arms and legs

- using a sunscreen with a high protection factor.

Other medicines and Mykofenolatmofetil Actavis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Mykofenolatmofetil Actavis can affect the way some other medicines work. Also other medicines can affect the way Mykofenolatmofetil Actavis works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start taking Mykofenolatmofetil Actavis:

azathioprine or other medicines which suppress your immune system – given after a transplant operation
aciclovir – used for treatment and prevention (in immunosuppressed individuals) of viral infections, such as cold sores, genital herpes, shingles and chickenpox

- cholestyramine – used to treat high cholesterol

- rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB)

- antacids, or proton pump inhibitors – used for acid problems in your stomach such as indigestion

- phosphate binders – used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood

medicines that interfere with liver circulation
ganciclovir (used for treatment and prevention of CMV (cytomegalovirus) infections), especially if you also have kidney problems
norfloxicin and metronidazole in combination

Vaccines

If you need to have a vaccine (a live vaccine) while taking Mykofenolatmofetil Actavis, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.

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

Mykofenolatmofetil Actavis with food and drink:

Taking food and drink has no effect on your treatment with Mykofenolatmofetil Actavis.

Pregnancy, contraception and breast-feeding

Contraception in women taking Mykofenolatmofetil Actavis

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

- Before you start taking Mykofenolatmofetil Actavis

- During your entire treatment with Mykofenolatmofetil Actavis

- For 6 weeks after you stop taking Mykofenolatmofetil Actavis.

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 had treatment for cancer, then there is still a chance you could become pregnant)

- Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)

- Your womb (uterus) has been removed by surgery (hysterectomy)

- Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)

- You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner’s syndrome or uterine agenesis

- You are a child or teenager who has not started having periods.

Contraception in men taking Mykofenolatmofetil Actavis

You must always use condoms during treatment and for 90 days after you stop taking Mykofenolatmofetil Actavis.

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 Mykofenolatmofetil Actavis 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 Mykofenolatmofetil Actavis if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.

Driving and using machines

Mykofenolatmofetil Actavis is not likely to affect you being able to drive or use any tools or machines.

3. How to take Mykofenolatmofetil Actavis

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

How much to take

The amount you take depends on the type of transplant you have had. The recommended doses are shown below. Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.

Kidney transplant

Adults

- The first dose is given within 3 days of the transplant operation.

- The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.

- Take 2 tablets in the morning and then 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 your child´s height and weight (body surface area – measured as square metres or “m²”). The recommended dose is 600 mg/m² taken twice a day.

Mykofenolatmofetil Actavis is not recommended for kidney transplant patients under 2 years of age.

Heart transplant

Adults

- The first dose is given within 5 days of the transplant operation.

- The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.

- Take 3 tablets in the morning and then 3 tablets in the evening.

Children and adolescents

- There is no information for the use of Mykofenolatmofetil Actavis in children with a heart transplant.

Liver transplant

Adults

- The first dose of oral Mykofenolatmofetil Actavis will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.

- The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.

- Take 3 tablets in the morning and then 3 tablets in the evening.

Children and adolescents

- There is no information for the use of Mykofenolatmofetil Actavis in children with a liver transplant.

Taking the medicine

Swallow your tablets whole with a glass of water.

- Do not break or crush them.

If you take more Mykofenolatmofetil Actavis than you should:

If you take more Mykofenolatmofetil Actavis than you should, talk to a doctor or go to a hospital straight away. Also do this if someone else accidentally takes your medicine. Take the medicine pack with you.

If you forget to take Mykofenolatmofetil Actavis:

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 Mykofenolatmofetil Actavis:

Do not stop taking Mykofenolatmofetil Actavis unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplanted organ.

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.

Talk to a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

- you have a sign of infection such as a fever or sore throat

- you have any unexpected bruising or bleeding

- you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).

Usual problems

Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:

- the number of your blood cells

- the amount of substances in your blood, such as sugar, fat, electrolytes, enzymes or cholesterol.

Children and adolescents

Children may be more likely than adults to have some side effects. These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.

Elderly patients

Elderly patients (≥65 years) may generally be at an increased risk of side effects. Elderly patients receiving [Invented name] in combination with other immunosuppressive medicines, may also be at a greater risk for certain infections, as well as gut bleeding and fluid on the lungs compared to younger patients.

Fighting infections

Mykofenolatmofetil Actavis reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.

Lymph and skin cancer

As can happen in patients taking this type of medicine (immunosuppressants), a very small number of Mykofenolatmofetil Actavis patients have developed cancer of the lymphoid tissues and skin.

General unwanted effects

You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle, pain on passing urine), headache, flu symptoms and swelling.

Other unwanted effects may include:

Skin problems such as:

- acne, cold sores, shingles, skin growth, hair loss, rash, itching.

Urinary problems such as:

- kidney problems or the urgent need to pass water (urine).

Digestive system and mouth problems such as:

- swelling of the gums, taste disturbance and mouth ulcers

- inflammation of the food pipe, pancreas, colon or stomach

- gut problems including bleeding and ulcers, liver problems

- constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence and burping/belching.

Nervous system problems such as:

- feeling dizzy, drowsy or numb

- tremor, muscle spasms, convulsions

- feeling anxious or depressed, changes in your mood or thoughts.

Heart and blood vessel problems such as:

- change in blood pressure, unusual heart beat, widening of blood vessels.

Lung problems such as:

- pneumonia, bronchitis

- 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

- fluid on the lungs or inside the chest

- sinus problems.