Transwel 180 mg/360 mg Tablets

Transwel contains an active ingredient called mycophenolate sodium, which is broken down to the potent mycophenolic acid. Transwel 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. Transwel 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. Transwel is used to prevent the body’s immune system from rejecting organs in patients receiving kidney transplants. Transwel should be used together with ciclosporin and steroid.

Do not take Transwel:

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

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

Warnings and Precautions

WARNING 1: Cancer - causing effects: Treatment with Transwel 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 Transwel.

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 Transwel. 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 Transwel 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. Condoms must be used by both fertile and sterilized men.

Treatment with Transwel should be initiated and maintained by appropriately qualified transplant specialists. Transwel should be initiated in new patients within 48 hours following transplantation. The recommended dose is 720 mg (four 180 mg or two 360 mg Transwel 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 Transwel. 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 Transwel 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 Transwel: 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.

Transwel can have side effects. Not all side effects reported for Transwel are included in this leaflet. Should your general health worsen while taking Transwel please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking Transwel 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.

Less frequent side - effects

• Discolouration of the skin due to blood disorders
• Underactive thyroid gland (characterised by weight gain, unusual weakness and depression) or overactive thyroid gland (characterised by irritability, fast irregular heart beat, increased sweating and weight loss)
• Cushing's syndrome (high levels of cortisol, characterised by upper body obesity, a rounded face, increased fat around the neck and thinning arms and legs)
• Seizures (fits), mood changes, seeing or hearing things that do not exist, nerve damage (characterised by muscle weakness, cramps and spasms or tingling, numbness and pain), abnormal thinking, an abnormal increase in sensitivity to stimuli of your senses, loss of contact with reality.
• A acidosis (too much acid in your body, after your doctor performed a urine test that checks your body's pH levels), dehydration (when your body loses more fluid than it takes in), increased weight
• Increased tightness of muscle tone
• Sensation of tingling, burning, pricking or numbness of the skin (“pins and needles”), sleepiness
• Vision disturbances, infection in the eye, cataract (cloudiness of the eye)
• Hearing loss
• Disturbances of your heart beat, heart disorders, heart failure, abnormally slow or fast heart beat
• Light headedness when standing up from a lying or sitting position
• Asthma, lung disorders (characterised by difficulty breathing, coughing up blood (classically seen as pink, frothy sputum), excessive sweating, anxiety, pale skin, flu-like symptoms, chest pain)
• Blood in your stools, fungus infection in your mouth, inflammation of the gums, mouth, oesophagus or pancreas, overgrowth of the gum tissue
• Skin cancers
• Liver disease (characterised by yellow colouration of the skin and eyes)
• Painfully or difficult urination, need to urinate more often than usual, loss of bladder control, production of abnormally small amounts of urine, excessive urination at night
• Feeling an abnormal lump beneath the skin, enlarged stomach, swelling of the face, flu-like symptoms, unusual weakness or tiredness, seeing or feeling a bulge in your stomach area, stomach pressure
• Leg cramps, muscle pain, joint pain, abnormal weakness of certain muscles
• Acne, temporary hair loss, skin rash, infection of the skin
• Runny nose, sore throat.

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).