Each tablet contains 500 mg mycophenolate mofetil.
Excipients/Inactive Ingredients: Microcrystalline cellulose, Povidone K-30, Croscarmellose sodium, Magnesium stearate.
Tablet coat: Hypromellose (HPMC 2910), Titanium dioxide (E171), Macrogol (PEG 400), Talc, Indigo carmine aluminium lake (E132), Iron oxide red (E172), Iron oxide black (E172).
Myfenax is a medicine that is used to suppress immune activity.
Myfenax is used to prevent the 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).
Always take Myfenax exactly as told by the doctor. Check with the doctor or pharmacist if unsure. 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 (aged 2 to 18 years): The dose given will vary depending on the size of the child. The doctor will decide the most appropriate dose based on body surface area (height and weight). The recommended dose is 600 mg/m2 taken twice daily.
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 (aged 2 to 18 years): No data are available to recommend the use of Myfenax in children who have received a heart transplant.
Liver Transplant: Adults: The first dose of Myfenax will be given at least 4 days after the transplant operation and when 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 and 3 tablets in the evening.
Children (aged 2 to 18 years): No data are available to recommend the use of Myfenax in children who have received a liver transplant.
Method and route of administration: Swallow tablets whole with a glass of water. Do not break or crush them and do not take any tablets that have broken open or split. Avoid contact with any powder that spills out from damaged tablets. If a tablet breaks open accidentally, wash any powder from the skin with soap and water. If any powder gets into the eyes or mouth, rinse thoroughly with plenty of plain fresh water.
Treatment will continue for as long as immunosuppression is needed to prevent the body from rejecting the transplanted organ.
Forgotten intake of Myfenax: If forgotten to take the medicine at any time, take it as soon as it is remembered, then continue to take it at the usual times. Do not take a double dose to make up for a forgotten dose.
Stopping intake of Myfenax: Do not stop taking Myfenax because of feeling better. It is important to take the medicine for as long as the doctor has told to. Stopping treatment with Myfenax may increase the chance of rejection of the transplanted organ. Do not stop taking the medicine unless the doctor tells to.
It is important not to take too many tablets. Contact the nearest hospital accident and emergency department or a doctor for advice if more tablets have been swallowed or if a child may have swallowed any.
Do not take Myfenax: If allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Myfenax; If breastfeeding.
Myfenax should not be given to women of childbearing potential who are not using highly effective contraception.
Myfenax treatment should not be initiated in women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy.
Myfenax should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Myfenax should not be given to women who are breastfeeding.
Inform the doctor immediately: If experiencing any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding; If with existing or history of any problems with the digestive system, e.g. stomach ulcers.
Myfenax reduces the body's defence mechanism. Because of this, there is an increased risk of skin cancer. Therefore, exposure to sunlight and ultraviolet (UV) light should be limited by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving Myfenax in combination with other immunosuppressants. In some of these cases, switching Myfenax to an alternative immunosuppressant resulted in serum IgG levels returning to normal. Patients on Myfenax who develop recurrent infections should have their serum immunoglobulins measured. In cases of sustained clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T- and B-lymphocytes.
There have been published reports of bronchiectasis in adults and children who received Myfenax in combination with other immunosuppressants. In some of these cases, switching Myfenax to another immunosuppressant resulted in improvement in respiratory symptoms. The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung. There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal. It is recommended that patients who develop persistent pulmonary symptoms, such as cough and dyspnea, are investigated.
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortion and congenital malformations in case of exposure during pregnancy.
Women with childbearing potential should use two reliable forms of contraception simultaneously before starting and during therapy, and for six weeks after stopping treatment; unless abstinence is the chosen method of contraception. Sexually active (including vasectomized) men are recommended to use condoms during treatment and for at least 90 days after cessation of treatment. Female partners of male patients treated with Myfenax are also recommended to use highly effective contraception for the same period.
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Before starting Myfenax treatment, women of childbearing potential should undergo pregnancy testing. Two serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL are recommended; the second test should be performed 8-10 days after the first one and immediately before starting mycophenolate. Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported).
Driving and using machines: Myfenax has not been shown to impair the ability to drive or operate machinery.
Do not take Myfenax if breastfeeding.
The doctor should advise about using contraception before taking Myfenax, whilst taking Myfenax, and for 6 weeks after stopping intake of Myfenax. Myfenax may cause spontaneous abortions or damage, including problems with the development of the ears, to the unborn baby.
Tell the doctor straight away if pregnant, breastfeeding, pregnancy occurs, or planning to start a family in the near future.
Like all medicines, Myfenax can have side effects, although not everybody gets them.
More common side effects are diarrhoea, decrease in normal amount of white and/or red blood cells in the blood, infection and vomiting. Children may be more likely than adults to have side effects such as diarrhoea, infections, decrease in normal amount of white and/or red blood cells in the blood.
General unwanted effects affecting the body as a whole include hypersensitivity (such as anaphylaxis, angioedema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/muscle, pain on passing urine), headache, flu symptoms and fluid retention in the body.
Other unwanted effects may include: Disorder of the skin such as cold sores and shingles; Urinary disorders such as kidney problems with increased level of urea; Disorders of the digestive system and mouth such as constipation, indigestion, pancreas inflammation, gastrointestinal bleeding, inflammation of the stomach, liver problems, loss of appetite, flatulence, inflammation of the mouth; Disorder of the nerves and senses such as convulsion, dizziness, drowsiness, numbness, muscle spasms; Metabolic, blood and vascular disorders such as weight loss, elevated uric acid, increased blood sugar, bleeding, bruising, change in blood pressure, abnormal heart beat and dilation of blood vessels; Disorder of the lungs such as pneumonia, bronchitis, breathlessness, cough, fluid in the lungs/chest cavity, inflammation of sinus.
Taking other medicines: Inform the doctor or pharmacist if taking, or have recently taken, any other medicines, even those not prescribed.
Talk to the doctor before starting intake of Myfenax if: Taking any medicines containing azathioprine or other immunosuppressive agents (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 renal kidney failure to reduce the absorption of phosphate), or any other medicines (including those that can be bought without a prescription); Receiving vaccines (live vaccines).
Taking Myfenax with food and drink: Taking food and drink has no influence on the treatment with Myfenax.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Myfenax FC tab 500 mg
50's
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