Lesor 180 mg/360 mg Tablets

Lesor contains an active ingredient called mycophenolate sodium, which is broken down to the potent mycophenolic acid. Lesor belongs to a group of medicines called immunosuppressants. Immunosuppressants are medicines that lower the body’s ability to reject a transplanted organ. The cells in the immune system that are responsible for regulating and triggering immune responses are white blood cells called T- and B- lymphocytes. Lesor works by reducing the production of these white blood cells. It does this by blocking the action of a compound called inosine monophosphate dehydrogenase, which is needed for their production. Lesor is used to prevent the body’s immune system from rejecting organs in patients receiving kidney transplants. Lesor should be used together with ciclosporin and steroid.

Do not take Lesor:

• If you are allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or any of the inactive ingredients on Lesor (see WHAT LESOR CONTAINS).
• If you are pregnant or breastfeeding.

Do not take Lesor if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lesor.

Warnings and Precautions

WARNING 1: Cancer - causing effects: Treatment with Lesor can result in increased infection and development of cancers, especially of the skin due to lowered immunity. Inform your doctor immediately if you develop unexpected bruising or bleeding. Only doctors specializing in transplant and immunosuppression therapy can prescribe Lesor.

WARNING 2: Birth defects and malformations: Mycophenolic acid causes inherited birth defects and spontaneous abortions when used during pregnancy. The doctor will conduct two pregnancy tests. The second test will be performed 8 – 10 days after the first one and before starting the treatment with Lesor. Repeat pregnancy test will be conducted routinely. Women who are still capable of having babies should use two types of contraceptive at the same time before, during and 6 weeks after Lesor treatment. Female patients should use intra-uterine devices (a form of birth control) with caution as it may also increase the risk of infection. Female partners of male patients should use very effective contraception during treatment for a total of 90 days after treatment. Sexually active men should use condoms during treatment and for at least 90 days after stopping treatment. Condom must be used by both fertile and sterilized men.

Treatment with Lesor should be initiated and maintained by appropriately qualified transplant specialists. Lesor should be initiated in new patients within 48 hours following transplantation. The recommended dose is 720 mg (four 180 mg or two 360 mg Lesor tablets) given twice daily (1440 mg daily dose). The product can be taken with or without food. The tablet should be swallowed whole with a glass of water. Tablet should not be crushed. Avoid inhalation or direct contact with skin or mucous membrane of the powder, in case of accidental breakage of the Lesor. Kidney transplant patients with serious kidney damage should be carefully observed. No dose adjustment is required for the elderly and patients with delayed renal graft function post-transplant. Patients with severe chronic renal damage, however, should be carefully monitored.

If you take more Lesor than you should: In the event of an overdosage contact your doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison centre. Take this leaflet and any remaining capsules or tablets with you, so that the doctor knows what you have taken.

If you forget to take Lesor: If you missed a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take the capsule(s) or tablet(s) at the usual time. Do not take a double or larger dose to make up for the forgotten individual doses.

Lesor can have side effects. Not all side effects reported for Lesor are included in this leaflet. Should your general health worsen while taking Lesor please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking Lesor and tell your doctor immediately or go to the casualty department at your nearest hospital:

Less frequent side-effects:

• Fast or irregular breathing and/or heartbeat
• Hive-like swelling on face, eyelids, mouth, lips or tongue
• Shortness of breath or difficulty breathing.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side-effects:

• Signs of blood disorders such as excessive tiredness, dizziness, unexplained bleeding, bruising or looking pale
• High or low blood pressure
• High levels of cholesterol (fat) in your blood (which is determined by a blood cholesterol test by your doctor)
• Diabetes (characterised by frequent urination, excessive thirst, unusual tiredness)
• Low potassium levels in your blood (characterised by vomiting, nausea, constipation, low blood pressure) or abnormally high potassium levels in your blood (characterised by nausea, unusual weakness or tiredness, muscle weakness)
• Abnormally low levels of magnesium in your blood (characterised by weakness, muscle cramps or irregular heartbeats)
• Abnormally low levels of sodium (salt) in your blood (characterised by nausea and vomiting, headache, confusion, unusual weakness or tiredness, appetite loss, restlessness, irritability, muscle weakness, spasms or cramps)
• Abnormally low levels of phosphate in your blood (characterised by muscle dysfunction and weakness, irritability, confusion)
• Nervous excitement, anxiety, confusion, depression
• Blood in your urine
• Bladder infection (characterised by burning when you are urinating), difficulty with urination, white foam in your urine, intense pain in the area between your hips and ribs
• Pneumonia (inflammation of the lungs caused by a bacterial or viral infection, characterised by coughing, fever, shaking, chills, shortness of breath and sharp or stabbing chest pain during deep breaths)
• Sepsis (bacterial infection in your bloodstream or body tissues, characterised by fever, low body temperature and fast breathing)
• Dizziness, trouble in sleeping, trembling or shaking of hands or feet
• Swelling of lower legs or feet
• Diarrhoea, nausea, vomiting, constipation, heartburn
• Unusual weakness or tiredness, fever, headache, stomach pain, back pain, chest pain
• Hay fever.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C in a cool dry place. Store in the original package until ready for use. KEEP ALL MEDICINES OUT OF REACH OF CHILDREN. Do not use the medicine after the expiry date shown on the label or carton. Return the expired medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).