Mycophenolate Mofetil Sandoz (Mycophenolate Mofetil)
Mycophenolate Mofetil Sandoz 250 Mg Capsules, Hard
Mycophenolate Mofetil
1. What Mycophenolate Capsules are and what they are used for
Mycophenolate mofetil Sandoz 250 mg Capsules belong to the class of drugs known as immunosuppressants. Mycophenolate capsules are used to prevent your body rejecting a transplanted kidney heart or liver. Mycophenolate is used together with other drugs known as ciclosporin and corticosteroids.
2. Before you take Mycophenolate Capsules
Do not take Mycophenolate Capsules:
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Mycophenolate Capsules.
• If you are breastfeeding.
Take special care with Mycophenolate Capsules:
• Tell your doctor if you have, or ever have had any problems with your digestive system, e.g., stomach ulcers.
• Tell your doctor if you suffer from an enzyme defect called ‘Lesch-Nyhan syndrome’ or ‘Kelley Seegmiller syndrome’
• Limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor. There is an increased risk of skin cancer because mycophenolate reduces your body’s defense mechanism.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Take care with the following medicines:
• Azathioprine or tacrolimus or other immunosuppressive agents (which are sometimes given to patients after a transplant operation)
• Colestyramine (used to treat patients with high blood cholesterol)
• Rifampicin (antibiotic)
• Antacids (for heartburn)
• Phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate)
• Aciclovir, ganciclovir (for viral infections)
• Live vaccines should be avoided. Your doctor will have to advise you what is indicated for you
Pregnancy and breast-feeding:
Ask your doctor for advice before taking any medicine. You must not use mycophenolate during pregnancy unless clearly indicated by your doctor.
Tell your doctor straight away if you are breast-feeding, become pregnant or plan to start a family in the near future.
Your doctor should advise you about using contraception before taking mycophenolate, whilst taking mycophenolate, and for 6 weeks after you have stopped taking mycophenolate. This is because mycophenolate may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Do not take any mycophenolate if you are breastfeeding
Driving and using machines:
Mycophenolate has not been shown to impair your ability to drive or operate machinery.
3. How to take Mycophenolate Capsules
Always take Mycophenolate Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is as follows:
Kidney Transplant
Adults:
The first dose will be given within 72 hours after the transplant operation. The recommended daily dose is 8 capsules (2 g of the active
ingredient) taken as 2 separate doses.This means taking 4 capsules in the morning then 4 capsules in the evening.
Children (aged 2 to 18 years):
The dose given will vary depending on the size of the child. Your doctor will decide the most appropriate dose based on body surface area
(height and weight). The recommended dose is 600 mg/m2 taken twice a day.
Heart Transplant
Adults:
The first dose will be given within 5 days following the transplant operation. The recommended daily dose is 12 capsules (3g of the active
ingredient) taken as 2 separate doses.This means taking 6 capsules in the morning then 6 capsules in the evening.
Children:
No data are available to recommend the use of mycophenolate in children who have received a heart transplant
Liver Transplant
Adults:
The first dose of oral mycophenolate will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications. The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses. This means taking 6 capsules in the morning then 6 capsules in the evening.
Children:
No data are available to recommend the use of mycophenolate in children who have received a liver transplant.
Method and route of administration
Swallow your capsules whole with a glass of water. Do not break or crush them and do not take any capsules that have broken open or split Avoid contact with any powder that spills out from damaged capsules. If a capsule breaks open accidentally, wash any powder from your skin with soap and water, if any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.
Treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplanted organ
If you take more Mycophenolate Capsules than you should:
If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.
If you forget to take Mycophenolate Capsules: Do not worry, take it as soon as you remember If it is almost time to take the next dose, wait until then and continue with your usual schedule.
Do not double the dose to make up for the one missed
If you stop taking Mycophenolate Capsules:
Stopping your treatment with mycophenolate may increase the chance of rejection of your transplanted organ. Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, Mycophenolate Capsules can cause side effects, although not everybody gets them
Serious side effects
If you notice one of the following serious side effects, talk to your doctor or go to a hospital immediately:
Following serious side-effects are common (affect less than 1 out of 10 people):
• In case of any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding
• Unusual bruising or bleeding, includes vomiting blood or passing blood in your stools
• Fits (convulsions)
• Yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine (signs of inflamed liver)
Following serious side-effects are very rare (affect less than 1 out of 10,000 people)
• Hypersensitivity reactions (anaphylaxis, angioedema): If you develop a swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty in breathing or swallowing, or extreme dizziness
Other possible side-effects
Elderly patients may generally be at increased risk of side effects.
Children may be more likely than adults to have side effects such as diarrhoea, infections, fewer white cells and fewer red cells in the blood
Following side-effects are very common (affect more than 1 out of 10 people)
• Fewer white cells and/or red cells or platelets in your blood. Your doctor will do regular blood tests to monitor any changes in the number of your blood cells or changes in the levels of any of the substances carried in your blood, e.g. sugar, fat, cholesterol
• Diarrhoea, feeling or being sick, abdominal pain
• Cold sores, shingles
• Urinary tract infections, urgent need to pass urine
Following side-effects are common (affect less than 1 out of 10 people)
• Infections of the brain, skin, mouth, stomach and intestines, and lungs: Mycophenolate reduces your body’s own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver. Consequently your body will not be as good as normal at fighting infections. So if you are taking mycophenolate you may therefore catch more infections than usual.
• As can happen in patients taking this type of medicine, a very small number of mycophenolate patients have developed cancer of the lymphoid tissues and skin.
• Infections, such as flu symptoms, vaginal thrush
• Metabolic and nutrition disorders, such as weight loss, loss of appetite, gout, high blood sugar, high blood fat and cholesterol
• Blood, cardiac and vascular disorders such as bleeding, bruises, increased level of white blood cells, change in blood pressure, abnormal heart beat and dilation of blood vessels
• Nervous system and psychiatric disorders such as convulsions, tremor, dizziness, numbness, muscle spasms, headache, anxiety depression, confusion, agitation, drowsiness, changes in thinking or mood, insomnia
• Respiratory and thoracic disorders such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/chest cavity, sinus problems, runny or blocked nose (rhinitis), pharyngitis
• Gastrointestinal disorders such as constipation, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach or oesophagus, gastric ulcer, duodenal ulcer, liver problems, inflammation of the colon, inflammation of the abdominal cavity flatulence, swelling of the gum, mouth ulcers and impaired taste
• Skin disorders such as acne, skin growth, hair loss, rash, itching
• Renal and urinary disorders such as kidney problems
• General disorders such as fever, chills, malaise, weakness, pain (such as chest, joint/muscle), and swelling
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. However, do not stop taking your medicine unless you have discussed this with your doctor first.
5. How to store Mycophenolate Capsules
Keep out of the reach and sight of children
Do not use Mycophenolate Capsules after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. After first opening of the container: use within 2 months. Do not store above 30°C
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required These measures will help to protect the environment.
6. Further information
What Mycophenolate Capsules contain
• The active substance is mycophenolate mofetil. Each capsule contains 250 mg of mycophenolate mofetil.The other ingredients in the capsule content are pregelatinised starch, croscarmellose sodium, povidone (K-90F) magnesium stearate.
• The capsule shell consists of gelatine, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132)
What Mycophenolate Capsules look like and contents of the pack
Hard gelatin capsules (size 1) with blue opaque cap and orange opaque body
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