Arzip (Mycophenolate Mofetil)
Arzip 250 mg Capsules
(Mycophenolate Mofetil)
Immunosuppressants.
Arzip capsules are used to prevent your body rejecting a transplanted kidney, heart or liver. Arzip is used together with other medicines known as ciclosporin and corticosteroids
Do not take Arzip
• if you are hypersensitive (allergic) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Arzip
• if you are breast feeding.
Take special care with Arzip
You should inform your doctor immediately:
• if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
• if you have problems, or have had problems with your digestive system, e.g., stomach ulcers.
Arzip reduces your body’s defence mechanism. Because of this, there is an increased risk of skin cancer. Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using sunscreen with a high protection factor.
Taking with other medicines
Please inform your doctor or pharmacist if you are taking/using other medicines or have recently taken/used other medicines, even if these were obtained without a prescription.
If the answer to any of the following questions is “yes“, talk to your doctor before you start to take Arzip:
• Are you taking medicines that contain azathioprine or other immunosuppressant substances (which are sometimes given to patients after an organ transplant), colestyramine (for the treatment of patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription), that your doctor does not know about?
• Do you need vaccinations (live vaccines)? Your doctor will advise you which vaccination is suitable for you.
Taking Arzip with food and drink
Food and drink do not affect your treatment with Arzip.
Pregnancy and breast-feeding
Do not take Arzip if you are breast-feeding.
You must not use Arzip during pregnancy unless clearly indicated by your doctor. Your doctor should advise you about using contraception before taking Arzip, whilst taking Arzip, and for 6 weeks after you have stopped taking Arzip. This is because Arzip may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Driving and using machines:
Arzip has not been shown to impair your ability to drive or use machines.
Always take Arzip exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Arzip is usually taken as follows:
Renal transplant (Kidney):
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 and 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 daily.
Heart transplant:
Adults:
The first dose will be given within 5 days following the transplant operation.
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 and 6 capsules in the evening.
Children
No data are available to recommend the use of Arzip in children who have received a heart transplant.
Liver transplant
Adults:
The first dose of oral Arzip 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 (3g of the active ingredient), taken as 2 separate doses. This means taking 6 capsules in the morning and 6 capsules in the evening.
Children
No data are available to recommend the use of Arzip 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.
• The treatment will continue for as long as you need immunosuppression to prevent your transplanted organ from being rejected.
If you take more Arzip than you should
If you take more capsules than you should or if someone else has accidentally taken your capsules, consult a doctor immediately or go to the hospital straight away.
If you forget to take Arzip
If you have forgotten to take your medicine take it as soon as you remember. Then continue to take it at the usual times.
If you stop taking Arzip
Stopping your treatment with Arzip 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.
Like all medicines, Arzip can have side effects, although not everybody gets them.
Some of the more usual problems are diarrhoea, fewer white cells and/or red cells in your blood, infection and vomiting. 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. 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.
Arzip 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 Arzip you may therefore catch more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract. As can happen in patients taking this type of medicine, a very small number of Arzip patients have developed cancer of the lymphoid tissues and skin.
General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/muscle, pain on passing urine), headache, flu symptoms and swelling.
Other unwanted effects may include:
Disorders of the skin such as acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Urinary disorders such as kidney problems or the urgent need to pass urine.
Disorders of the digestive system and mouth such as constipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence, swelling of the gums and mouth ulcers.
Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.
Metabolic, blood and vascular disorders such as weight loss, gout, high blood sugar, bleeding, clots and bruises, change in blood pressure, abnormal heart beat and dilation of blood vessels may be seen.
Disorders of the lungs such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/chest cavity, sinus problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet whilst you are taking Arzip please tell your doctor or pharmacist. However, do not stop taking your medicine unless you have discussed this with your doctor first.
Keep out of the reach and sight of children.
Do not use the capsules after the expiry date (Exp 
.
Do not store above 30°C. Store in the original package in order to protect from moisture.
Medicines should not be disposed of via waste water or in the household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help protect the environment.
What Arzip 250 mg Capsules contain
The active substance is mycophenolate mofetil.
The other ingredients of Arzip 250 mg Capsules are:
Content of the capsules:
- cellulose microcrystalline
- hydroxy propyl cellulose
- povidone K 90
- croscarmellose sodium
- talc
- magnesium stearate
Capsule shells:
- gelatin
- sodium lauryl sulphate
- potassium hydroxide
- shellac
- propylene glycol
- indigo carmine (E132)
- titanium dioxide (E171)
- iron oxide red (E172)
- iron oxide yellow (E172)
- black iron oxide (E 172)
What Arzip 250 mg Capsules look like and contents of the pack
Arzip 250 mg Capsules are light blue/peach, size ’1′ hard gelatin capsules imprinted with ‘MMF’ on cap and ’250′ on body.
Arzip 250 mg Capsules are obtainable in blister packs of 20, 100 and 300 capsules. Not all pack sizes may be marketed.
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