How does it work?

Myfortic tablets contain the active ingredient mycophenolatesodium, which is a type of medicine called an immunosuppressant. Thesemedicines reduce the body's immune response. Mycophenolate is broken down inthe body to the active medicine called mycophenolic acid.

The immune system normally protects the body from foreign cellsand infections by producing antibodies to fight them. A transplanted organ canbe attacked by the immune system, as it is recognised by the body as a foreignsubstance. This is known as "transplant rejection".

Mycophenolate works by blocking the action of a compound calledinosine monophosphate dehydrogenase, which is required for producing certainblood cells called T- and B-lymphocytes. These are immune cells that areresponsible for regulating and triggering immune responses and therebyproviding a defence against infection and foreign cells in thebody.

By reducing the production of these cells, mycophenolate makesthe body less likely to reject foreign material such as transplantedorgans.

Mycophenolate is used together with other immunosuppressivemedicines (ciclosporin and corticosteroids) as part of the transplant regimento prevent rejection of heart, kidney and liver transplants. However, Myfortictablets are only licensed for kidney transplants.

What is it used for?

• Preventing the body rejecting a transplanted kidney (in combination with ciclosporin and corticosteroids).

Warning!

• Myfortic tablets should be swallowed whole and not broken or crushed. If a tablet has been accidentally broken or crushed, avoid touching or inhaling the powder. If any powder gets on your skin, was the skin thoroughly with soap and water. If powder gets in your eyes, rinse the eyes immediately with plain water.
• This medicine may rarely cause a decrease in the normal amounts of blood cells in the blood. For this reason you will need to have regular blood tests to monitor the levels of your blood cells. This should be weekly for the first month, twice a month for the 2nd and 3rd months and then monthly through the first year of treatment. If your white blood cell count falls below a certain level during treatment, your doctor may ask you to stop taking this medicine. You should consult your doctor immediately if you experience any of the following symptoms during treatment, as they may be signs of a problem with your blood cells: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness.
• People having long-term or intensive immunosuppressive treatment are at increased risk of developing lymphomas and other cancers, particularly skin cancer. Therefore, to reduce the risk of skin cancer, you should minimise your exposure to strong sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor. Discuss this with your doctor.
• Women who could get pregnant should use an effective method of contraception to prevent pregnancy during treatment with this medicine, because it may be harmful to a developing baby. Contraception should be continued for at least six weeks after stopping treatment. Consult your doctor immediately if you think you could be pregnant.

Use with caution in

• Serious digestive system disease that is currently active.
• Rare hereditary diseases where there is a deficiency of an enzyme called HGPRT, eg Lesch-Nyhan or Keelley-Seegmiller syndrome.

Not to be used in

• Allergy to mycophenolate sodium, mycophenolate mofetil or mycophenolic acid.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Myfortic tablets contain lactose).

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine may be harmful to a developing baby and for this reason, it is recommended that a pregnancy test is performed before treatment is started.
• This medicine is not recommended for use in women who are pregnant, unless considered essential by your doctor because there is no suitable alternative treatment available. Seek medical advice from your doctor.
• Women who could get pregnant should use an effective method of contraception to prevent pregnancy during treatment with this medicine. Contraception should be continued for at least six weeks after stopping treatment. You should consult your doctor immediately if you think you could be pregnant.
• It is not known if this medicine passes into breast milk. However, because it could be harmful to a nursing infant if it does pass into the milk, it should not be used during breastfeeding. Mothers who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Label warnings

• This medication should be swallowed whole, not broken, chewed or crushed.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Decrease in the number of white blood cells, platelets or red blood cells in the blood (leucopenia, thrombocytopenia or anaemia)
• Increased susceptibility to infections.
• Disturbances in the levels of chemical components (electrolytes) in the blood.
• Ulceration or bleeding in the stomach or intestines.
• Headache.
• Depression, anxiety.
• Confusion.
• Seizures (convulsions).
• Dizziness.
• Tremor, pins and needles sensations (paraesthesia).
• Difficulty sleeping (insomnia).
• Alteration in taste, loss of appetite.
• Cough, shortness of breath (dyspnoea).
• Cold or flu-like symptoms.
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).
• Inflammation of the liver (hepatitis), jaundice.
• Changes in blood pressure, increased heart rate.
• Rash, acne, hair loss.
• Increased risk of developing lymphomas and other cancers, particularly skin cancer (see warning above).

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

The manufacturer of this medicine recommends that it should notbe used in combination with azathioprine, as they have not studied the effectof this combination.

The body's response to vaccination is reduced by medicines suchas mycophenolate, which suppress the immune system and prevent the body formingadequate antibodies. Therefore, vaccines may less effective in people takingthis medicine. Live vaccines may cause infection in people taking this medicineand these should therefore be avoided. Live vaccines include the following:oral polio; rubella; measles, mumps and rubella (MMR); BCG; yellow fever andoral typhoid vaccines.

The following medicines reduce the absorption of mycophenolatefrom the gut and may therefore reduce the amount in the blood. As this couldmake it less effective, these medicines should not be taken within two to threehours of taking mycophenolate (ask your pharmacist for moreadvice):

• antacids (indigestion remedies)
• colestyramine
• iron tablets or liquids
• sevelamer.

The following medicines may also decrease the amount of thismedicine in the blood:

• ciclosporin
• norfloxacin and metronidazole used together
• rifampicin.

If people with decreased kidney function take any of thefollowing medicines in combination with mycophenolate, the blood levels of bothmedicines may be higher than normal and as a result they should be closelymonitored:

• aciclovir
• ganciclovir
• valaciclovir
• valganciclovir.

Other medicines containing the same active ingredient

CellCept containsmycophenolate mofetil. However, Cellcept and Myfortic are not interchangeable.because the body handles these different brands of mycophenolate in slightlydifferent ways. Switching between the two should be avoided.