Mycophenolate Mofetil 500 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOPHENOLATE MOFETIL 500mg FILM-COATED TABLETS
Mycophenolate Mofetil
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 further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What isin this leaflet:
1. What Mycophenolate Mofetil Tablets is and what it is used for
2. What you need to know before you take Mycophenolate Mofetil Tablets
3. How to take Mycophenolate Mofetil Tablets
4. Possible side effects
5. How to store Mycophenolate Mofetil Tablets
6. Contents of the pack and other information
1. What Mycophenolate Mofetil Tablets is and what it is used
for
Immunosuppressants.
Mycophenolate Mofetil Tablets are used to prevent your body rejecting a transplanted kidney, heart or liver. Mycophenolate Mofetil Tablets is used together with other medicines known as ciclosporin and corticosteroids.
2. What you need to know before you take Mycophenolate Mofetil Tablets
Do not take Mycophenolate Mofetil Tablets
• 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 breastfeeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Mycophenolate Mofetil Tablets.
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 or ever have had any problems with your digestive system, e.g. stomach ulcers.
• If you are planning to become pregnant, or if you fall pregnant while taking Mycophenolate Mofetil
If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Mycophenolate Mofetil.
The effect of sunlight
Mycophenolate Mofetil reduces 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 Tablets:
Please tell your doctor or pharmacist if you are taking or have recently taken, any other medicines.
This includes medicines obtained without a prescription, including herbal medicines. This is because Mycophenolate Mofetil can affect the way some other medicines work. Also other medicines can affect the way Mycophenolate Mofetil works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start Mycophenolate Mofetil:
• azathioprine or other medicines which suppress your immune system - given after a transplant operation
• cholestyramine - 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, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.
Mycophenolate Mofetil Tablets with food and drink:
Taking food and drink has no influence on your treatment with Mycophenolate Mofetil Tablets. Pregnancy and breast-feeding:
If you are pregnant, do not take Mycophenolate Mofetil. This is because Mycophenolate Mofetil 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 for your health are more important than the possible risks to your unborn baby.
If you plan to become pregnant, discuss with your doctor alternative medicines to best prevent rejection of your transplanted organ.
If you become pregnant while taking Mycophenolate Mofetil, do not stop taking it, but tell your doctor about your pregnancy as soon as possible
If you are able to become pregnant, you must have a pregnancy test before you start Mycophenolate Mofetil. You can only start Mycophenolate Mofetil 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 (bilateral salpingo-oophorectomy).
- Your womb (uterus) has been surgically removed (hysterectomy).
- You have premature failure of the ovaries, confirmed by a specialist gynaecologist.
- You have been diagnosed with one of the following rare conditions that some patients are born with that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis.
- You are a child/teenager who has not started having periods, and cannot become pregnant
Contraception
You must always use an effective method of contraception with Mycophenolate Mofetil. This includes:
• before you start taking Mycophenolate Mofetil
• during your entire treatment with Mycophenolate Mofetil
• for 6 weeks after you stop taking Mycophenolate Mofetil.
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 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 Tablets has not been shown to impair your ability to drive or operate machinery.
3. How to take Mycophenolate Mofetil Tablets
Always take Mycophenolate Mofetil exactly as your doctor has told you. You should 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 usual doses are shown below. Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.
Kidney transplant
Adults
• The first dose is given within 3 days of the transplant operation.
• The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.
• Take 2 tablets in the morning and then 2 tablets 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 your child's height and weight (body surface area - measured as square metres or “m2”). The recommended dose is 600 mg/ m2 taken twice a day.
Heart transplant Adults
• The first dose is given within 5 days of the transplant operation.
• The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in the evening.
Children
• There is no information for the use of Mycophenolate Mofetil in children with a heart transplant.
L
Liver transplant Adults
• The first dose of oral Mycophenolate Mofetil 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 6 tablets (3 g of the medicine) taken as 2 separate doses.
• Take 3 tablets in the morning and then 3 tablets in the evening.
Children
• There is no information for the use of Mycophenolate Mofetil in children with a liver transplant.
Method and route of administration:
Swallow your tablets whole with a glass of water. Do not break or crush them.
Treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplanted organ.
If you take more Mycophenolate Mofetil Tablets than you should
If you take more Mycophenolate Mofetil Tablets than you have been told to take, or if someone else accidentally takes Mycophenolate Mofetil Tablets, immediately see a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Mycophenolate Mofetil Tablets
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 missed dose.
If you stop taking Mycophenolate Mofetil Tablets
Stopping your treatment with Mycophenolate Mofetil Tablets 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 further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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).
Other possible side effects:
Very common (may affect more than one in 10 people)
Digestive system and mouth problems such as:
• feeling sick (nausea)
• vomiting
Blood and lymphatic system disorders
• fewer white cells or red cells in your blood
Infections and infestations
• Stomach and gut infections
• Urinary system infections
• Mouth infections
Common (may affect up to 1 in 10 people)
Infections and infestations
• Lung infections
• Skin sinfections
Lymph and skin cancer
• cancer of the lymphoid tissues and skin.
General disorders
• fever, feeling very tired, difficulty sleeping
• pains (such as stomach, chest, joint or muscle, pain on passing urine)
• headache, flu symptoms and swelling.
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, indigestion, loss of appetite, flatulence, diarrhoea.
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 heartbeat, widening of blood vessels.
Lung problems such as:
• pneumonia, bronchitis
• shortness of breath, cough
• fluid on the lungs or inside the chest
• sinus problems.
Other problems such as:
• weight loss, gout, high blood sugar
Not known (frequency cannot be estimated from the available data)
Infections and infestations • Brain infections
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.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
For Malta- ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens, GZR-1368 Gzira
Website: www.medicinesauthoritv.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O'Malley House, Earlsfort Centre,
Earlsfort Terrace
Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517
Website: www.imb.ie(http://www.imb.ie)
e-mail: imbpharmacovigilance@imb.ie
5. How to store Mycophenolate Mofetil Tablets
• Do not store above 25°C. Keep the blister in outer carton in order to protect from light.
• 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 (EXP). The expiry date refers to the last day of that month.
• Always return any leftover medicine to your pharmacist. Only keep it if your doctor tells you to.
• 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 Tablets contain:
The active substance is 500mg as mycophenolate mofetil.
The other ingredients are :
Core tablet :
cellulose microcrystalline, povidone, hydroxypropyl cellulose, croscarmellose sodium, talc, magnesium stearate.
Coating materials :
hypromellose 6 cps, titanium dioxide (E171), macrogol 400, iron oxide red (E172), indigo carmine aluminium lake (E132), iron oxide black (E172).
What Mycophenolate Mofetil Tablets looks like and content of the pack:
Mycophenolate Mofetil Tablets 500mg are purple colored, capsule shaped, biconvex, film coated tablets debossed “AHI” on one side and “500” on other side.
Mycophenolate Mofetil Tablets are available in blisters in packs of 50 tablets and 150 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare Limited,
Sage house, 319, Pinner Road,
North Harrow, Middlesex HA1 4HF,
UK.
Manufacturer:
CEMELOG- BRS
2040 Budaors, Vasut u.13
Hungary
Accord Healthcare Limited,
Sage house, 319, Pinner Road,
North Harrow, Middlesex HA1 4HF,
UK.
The leaflet was last revised in 01/2014.