Myfortic ® 180 mg/360 mg Tablets

What MYFORTIC is: MYFORTIC tablets belong to the class of medicines known as immunosuppressants. Immunosuppressants reduce your body’s response to anything that it sees as “foreign” – which includes transplanted organs.

What MYFORTIC is used for: MYFORTIC is used to prevent your body from rejecting a transplanted kidney. MYFORTIC is used together with other medicines containing ciclosporin and corticosteroids.

MYFORTIC will only be prescribed for you by a doctor with experience in transplantation medicine. Follow your doctor’s instructions carefully.

Do not take MYFORTIC:

• If you are allergic (hypersensitive) to mycophenolic acid, mycophenolate sodium or mycophenolate mofetil or to any of the other ingredients of MYFORTIC listed at the beginning of this leaflet. If you think you may be allergic, ask your doctor for advice.
• 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
• if you are breast - feeding

Warnings and precautions

Take special care with MYFORTIC:

• During exposure to sunlight;
• MYFORTIC reduces your body’s defence mechanism, causing an increased risk of skin cancer. You should therefore limit your exposure to sunlight and UV light by wearing appropriate protective clothing and frequently applying a sunscreen with a high protection factor;
• if you already had hepatitis B or C MYFORTIC may increase the risk of these diseases re - appearing. Your doctor may perform blood analysis and check for symptoms of these diseases. If you experience any symptoms (yellow skin and eyes, nausea, loss of appetite, dark urine) you should inform your doctor immediately;
• if you experience any symptoms of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding. In such cases you should inform your doctor immediately;
• if you need to receive vaccines (live vaccines). Seek your doctor’s advice first;
• if you have, or have ever had, a serious disorder of the digestive tract, e.g. stomach ulcer;
• if you have a rare hereditary enzyme deficiency of hypoxanthine - guanine phosphoribosyl - transferase (HGPRT) such as Lesch - Nyhan syndrome (also known as Kelley - Seegmiller syndrome);
• if you are a woman of child - bearing age: treatment with MYFORTIC should not be initiated until a negative pregnancy test has been obtained and you should use contraception during treatment and for at least 6 weeks after stopping the treatment;
• use of MYFORTIC in pregnancy may increase the risk of birth defects and pregnancy loss including spontaneous abortion (see section Pregnancy and breastfeeding and fertility). If any of these apply to you, tell your doctor before you take MYFORTIC.

MYFORTIC and older people:

• MYFORTIC can be given to the elderly.
• No dose adjustment is required.

Children/ and adolescents:

• Safety and efficacy in children have not been established.

Other medicines and MYFORTIC

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines (this includes complementary or traditional medicines). Remember to mention those you have bought without a prescription to your doctor; this includes antacids (medicines used to treat dyspepsia and heartburn). It is particularly important that you tell your doctor if you are taking any of the following medicines:

• Azathioprine, or any other immunosuppressive agent.
• Cholestyramine (a medicine used to treat high blood cholesterol levels).
• Aciclovir (a medicine used to treat herpes infection).
• Ganciclovir (a medicine used to treat cytomegalovirus [CMV] infection).

Do not share medicines prescribed for you with others. Always take MYFORTIC exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Do not exceed the recommended dosage. The usual dose is:

• The recommended daily dose is 1 440 mg (8 tablets of MYFORTIC 180 mg or 4 tablets of MYFORTIC 360 mg), taken as 2 separate doses of 720 mg each.
• This means taking 4 tablets of MYFORTIC 180 mg or 2 tablets of MYFORTIC 360 mg in the morning and 4 tablets of MYFORTIC 180 mg or 2 tablets of MYFORTIC 360 mg in the evening.
• The first dose of 720 mg will be given within 48 hours after transplantation.
• Your doctor will tell you exactly how many MYFORTIC tablets to take.
• If you have the impression that the effect of MYFORTIC is too strong or too weak, talk to your doctor or pharmacist.

When and how to take MYFORTIC:

• Swallow the tablets whole with a glass of water.
• Do not break or crush them and do not take any tablets that are broken or split.

How long to take MYFORTIC:

Treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplanted kidney.

If you take more MYFORTIC than you should:

• If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention.
• In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

If you forget to take MYFORTIC:

• Do not take a double dose to make up for forgotten individual doses.
• If you forget to take MYFORTIC, take it as soon as you remember, then continue to take it at the usual times.
• Ask your doctor for advice.

Effects when treatment with MYFORTIC is stopped:

• Stopping your treatment with MYFORTIC may increase the risk of your transplanted organ being rejected.
• Do not stop taking your medicine unless your doctor tells you to.

MYFORTIC can have side effects. Not all side effects reported for MYFORTIC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MYFORTIC, please consult your healthcare professional for advice.

If any of the following happens, stop taking MYFORTIC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MYFORTIC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• If you have symptoms of infection including fever, chills, sweating, feelings of tiredness, drowsiness, or lack of energy. If you are taking MYFORTIC you may be more susceptible to infections than usual. These may affect various body systems, the most common being the urinary tract, the respiratory tract and the skin;
• if you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These can be the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy;
• if you have enlarged glands, new or enlarging skin growths, or a change in an existing mole. As can happen in patients taking immunosuppressive medication, a very small number of MYFORTIC patients have developed cancer of the skin or lymph nodes;
• if you experience unusual tiredness, headache, shortness of breath with exercise or at rest, dizziness, chest pain, looking pale. These are all symptoms of anaemia (decrease in red blood cells);
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease including fatal pulmonary fibrosis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Constipation;
• diarrhoea;
• nausea;
• infections and a reduction in the number of white blood cells;
• reduced level of calcium in the blood, sometimes leading to cramps, (hypocalcaemia);
• muscle weakness, muscle spasms, abnormal heart rhythm (possible symptoms of low level of potassium in the blood) (hypokalaemia);
• abnormal blood test results (high level of uric acid in the blood) (hyperuricaemia);
• headache, dizziness (possible symptoms of high blood pressure) (hypertension);
• dizziness, light - headedness (possible symptoms of low blood pressure) (hypotension);
• bleeding or bruising more easily than normal (signs of low level of platelets);
• muscle spasms, abnormal heart rhythm (possible symptoms of high level of potassium in the blood) (hyperkalaemia);
• abnormal blood test results (low level of magnesium in the blood) (hypomagnesaemia);
• excessive emotional distress, troubled (symptoms of anxiety);
• dizziness;
• headache, dizziness, possibly with nausea (possible symptoms of severe high blood pressure) (aggravated hypertension);
• shortness of breath, laborated breathing (possible symptoms of dyspnoea or exertional dyspnoea).

Your doctor will perform regular blood tests to monitor any changes in the number of your blood cells or in the levels of any of the substances carried in your blood, e.g. sugar, fat, and cholesterol;

The following side effects have been reported less frequently:

• Cyst containing lymph fluid;
• difficulty in sleeping;
• shakiness;
• lung congestion;
• shortness of breath;
• belching;
• bad breath;
• bowl obstruction;
• inflammation of the oesophagus;
• bloody or black stools;
• tongue discoloration;
• dry mouth;
• lip lesions;
• salivary glands blockage;
• heartburn;
• inflammation of the gums;
• inflammation of the lining of the abdominal cavity;
• flu - like symptoms;
• chills;
• swelling of ankles and feet;
• loss of appetite;
• back pain;
• muscle pain;
• hair loss;
• bruise of the skin;
• fast heart beat;
• discharge of the eye with itching;
• redness and swelling;
• vision blurred;
• false belief;
• kidney disorders;
• abnormal narrowing of the tube through which urine passes to the outside of the body;
• blood in the urine.

The following side effects have been reported but the frequency is unknown:

• Rash;
• fever, sore throat, frequent infections (possible symptoms of lack of white cells in the blood) (agranulocytosis).

Additional side effects have been reported with the class of medicines which MYFORTIC belongs to:

• Inflammation of the colon or of the oesophagus;
• abdominal pain, vomiting, loss of appetite, nausea (inflammation of the pancreas);
• intestinal perforation;
• stomach or intestine bleeding;
• stomach pain with or without bloody or black stools;
• bowl obstruction;
• serious infections;
• reduction in the number of specific white blood cells or of all blood cells.

If you notice any other side effects not mentioned in this leaflet, please inform your doctor. However, do not stop MYFORTIC tablets unless you have discussed this with your doctor first.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/. By reporting side effects, you can help provide more information on the safety of MYFORTIC.

• Do not store MYFORTIC above 30 °C.
• Store MYFORTIC in the original package.
• Do not use MYFORTIC after the expiry date printed on the box.
• Do not use any MYFORTIC pack that is damaged or shows signs of tampering.
• Return all unused MYFORTIC to your pharmacist.
• Do not dispose of unused MYFORTIC in drains or sewerage systems.
• Store all medicines out of reach of children.
• Do not store in a bathroom.