Mycophenolate Mofetil 250mg Capsules
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
T| What Mycophenolate mofetil capsules are and what they are used for
^1 What you need to know before you take Mycophenolate mofetil capsules "3 How to take Mycophenolate mofetil capsules "4 Possible side effects
How to store Mycophenolate mofetil capsules Contents of the pack and other information
T| What Mycophenolate mofetil capsules are and what they are used for
Mycophenolate mofetil capsules contain mycophenolate mofetil.
• This belongs to a group of medicines called "immune-suppressants'.
Mycophenolate mofetil capsules are used to prevent your body rejecting a transplanted organ.
• A kidney, heart or liver.
Mycophenolate mofetil capsules are used together with other medicines
• ciclosporin
• corticosteroids.
2 What you need to know before you take Mycophenolate mofetil capsules Do not take Mycophenolate mofetil capsules
• if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mycophenolate mofetil capsules
Warnings and precautions
Talk to your doctor before taking Mycophenolate mofetil capsules if:
• you have a sign of infection such as a fever or sore throat
• you have any unexpected bruising or bleeding
• you have ever had a problem with your digestive system such as a stomach ulcer
• you are planning to become pregnant, or if you get pregnant while taking Mycophenolate mofetil capsules.
If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Mycophenolate mofetil capsules.
The effect of sunlight
Mycophenolate mofetil capsules reduce your body's defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
• wearing protective clothing which also covers your head, neck, arms and legs
• using a sunscreen with a high protection factor.
Other medicines and Mycophenolate mofetil capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Mycophenolate mofetil capsules can affect the way some other medicines work. Also other medicines can affect the way Mycophenolate mofetil capsules work.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start Mycophenolate mofetil capsules:
• azathioprine or other medicines which suppress your immune system -given after a transplant operation
• colestyramine - used to treat high cholesterol
• rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis (TB)
• antacids, or proton pump inhibitors - used for acid problems in your stomach such as indigestion
• phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood.
Vaccines
If you need to have a vaccine (a live vaccine) while taking Mycophenolate mofetil capsules, talk to your doctor
or pharmacist first. Your doctor will have to advise you on what vaccines you can have.
Mycophenolate mofetil capsules with food and drink
Taking food and drink has no effect on your treatment with Mycophenolate mofetil capsules.
Pregnancy, contraception and breast-feeding
Pregnancy
• If you are pregnant, do not take Mycophenolate mofetil capsules. This is because Mycophenolate mofetil capsules may cause miscarriage
or damage to your unborn baby (affecting development of ears for example).
- In certain situations, you and your doctor may decide that the benefits of taking Mycophenolate mofetil capsules for your health are more important than the possible risks to your unborn baby.
• If you plan to become pregnant, talk to your doctor first. Your doctor will talk to you about other medicines you can take to prevent rejection of your transplant organ.
• If you think you may be pregnant tell your doctor straight away.
- However, keep taking Mycophenolate mofetil capsules until you see him or her.
If you are able to become pregnant, you must have a pregnancy test before you start Mycophenolate mofetil capsules. You can only start Mycophenolate mofetil capsules if the test is negative.
You are a woman who is not capable of becoming pregnant if any of the following applies to you:
• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant).
• Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo oophorectomy).
• Your womb (uterus) has been removed by surgery (hysterectomy).
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist).
• You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis.
• You are a child or teenager who has not started having periods. Contraception
You must always use an effective method of contraception with Mycophenolate mofetil capsules. This includes:
• Before you start taking Mycophenolate mofetil capsules
• During your entire treatment with Mycophenolate mofetil capsules
• For 6 weeks after you stop taking Mycophenolate mofetil capsules Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation.
Breast-feeding
Do not take Mycophenolate mofetil capsules if you are breast-feeding. This is because small amounts of the medicine can pass into the mother's milk.
Driving and using machines
Mycophenolate mofetil capsules are not likely to affect you being able to drive or use any tools or machines.
How to take Mycophenolate mofetil capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The amount you take depends on the type of transplant you have had. The recommended doses are shown below. Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.
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Kidney transplant
• Adults
- The first dose is given within 3 days of the transplant operation.
- The daily dose is 8 capsules (2g of the medicine) taken as 2 separate doses.
- Take 4 capsules in the morning and then 4 capsules in the evening.
• Children and adolescents (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 your child's height and weight (body surface area - measured as square metres or "m2"). The recommended dose is 600mg/m2 taken twice a day.
Heart transplant
• Adults:
- The first dose is given within 5 days of the transplant operation.
- The daily dose is 12 capsules (3g of the medicine) taken as 2 separate doses.
- Take 6 capsules in the morning and then 6 capsules in the evening.
• Children and adolescents:
- There is no information for the use of Mycophenolate mofetil capsules in children with a heart transplant.
Liver transplant
• Adults
- Thefirst dose of oral Mycophenolate mofetil capsules will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
- The daily dose is 12 capsules (3g of the medicine) taken as 2 separate doses.
- Take 6 capsules in the morning and then 6 capsules in the evening.
• Children and adolescents
- There is no information for the use of Mycophenolate mofetil capsules in children with a liver transplant.
Taking the medicine
Swallow your capsules whole with a glass of water.
• Do not break or crush them
• Do not take any capsules that have broken open or split.
Take care not to let any powder from inside a broken capsule get into your eyes or mouth.
• If this happens, rinse with plenty of plain water.
Take care not to let any powder from inside a broken capsule get onto your skin.
• If this happens, wash the area thoroughly with soap and water.
If you take more Mycophenolate mofetil capsules than you should
If you take more Mycophenolate mofetil capsules than you should, talk to a doctor or go to a hospital straight away. Also do this if someone else accidentally takes your medicine. Take the medicine pack with you.
If you forget to take Mycophenolate mofetil capsules
If you forget to take your medicine at any time, take it as soon as you remember. Then continue to take it at the usual times. Do not take a double dose to make up for a forgotten dose.
If you stop taking Mycophenolate mofetil capsules
Do not stop taking Mycophenolate mofetil capsules unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
"4| Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
• you have a sign of infection such as a fever or sore throat
• you have any unexpected bruising or bleeding
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).
Usual problems
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:
• the number of your blood cells
• the amount in your blood of things like sugar, fat or cholesterol.
Children may be more likely than adults to have some side effects. These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.
Fighting infections
Mycophenolate mofetil capsules reduce your body's defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
Lymph and skin cancer
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of Mycophenolate mofetil patients have developed cancer of the lymphoid tissues and skin.
General unwanted effects
You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle, pain on passing urine), headache, flu symptoms and swelling.
Other unwanted effects may include:
Skin problems such as:
• acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Urinary problems such as:
• kidney problems or the urgent need to pass water (urine). Digestive system and mouth problems such as:
• swelling of the gums and mouth ulcers
• inflammation of the pancreas, colon or stomach
• gut problems including bleeding, liver problems
• constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Nervous system problems such as:
• feeling dizzy, drowsy or numb
• tremor, muscle spasms, convulsions
• feeling anxious or depressed, changes in your mood or thoughts.
Heart and blood vessel problems such as:
• change in blood pressure, unusual heart beat, widening of blood vessels. Lung problems such as:
• pneumonia, bronchitis
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness
• fluid on the lungs or inside the chest
• sinus problems.
Other problems such as:
• weight loss, gout, high blood sugar, bleeding, bruising.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra. gov.uk/fyellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Mycophenolate mofetil capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
_6| Contents of the pack and other information
What Mycophenolate mofetil capsules contain
• The active substance is mycophenolate mofetil. Each capsule contains 250mg mycophenolate mofetil.
• The other ingredients are:
Capsule: microcrystalline cellulose, povidone (K-90), hydroxypropyl cellulose, croscarmellose sodium, talc, magnesium stearate.
Capsule shell: gelatine, sodium lauryl sulphate, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Ink: shellac, iron oxide black (E172).
What Mycophenolate mofetil capsules look like and contents of the pack
White opaque PVC/PVdC- Aluminium blister pack.
1 carton contains either 100 or 300 capsules.
Not all pack sizes may be marketed.
Mycophenolate mofetil capsules: light blue/peach, size 1 hard capsule, 18.9 mm ± 0.5 mm in length, imprinted with MMF on cap and 250 on body, containing white to off-white powder.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76 - 78, 220 Hafnarfjordur, Iceland Manufacturer
Actavis Nordic A/S, 0rnegardsvej 16, 2820 Gentofte, Denmark Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland This leaflet was last revised in August 2014.
k If you would like a
leaflet with larger text, please contact 01271 385257.
^actavis
Actavis, Barnstaple, EX32 8NS, UK
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