Mycophenolate Mofetil 500 Mg Film-Coated Tablets
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Mycophenolate mofetil (Referred to as Mycophenolate Tablets in this leaflet)
Read all of this leaflet carefully before you
start to take this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please 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.
What is in this leaflet:
1. What Mycophenolate Tablets are and what they are used for
2. What you need to know before you take Mycophenolate Tablets
3. How to take Mycophenolate Tablets
4. Possible side effects
5. How to store Mycophenolate Tablets
6. Contents of the pack and other information
1. What Mycophenolate Tablets are and what are they used for
The name of your medicine is Mycophenolate Film-Coated Tablets. The active ingredient is Mycophenolate mofetil. These tablets belong to a group of medicines called immunosuppressants, which are used to inhibit the activity of the immune system (your body's defence mechanism against infection).
Mycophenolate Tablets should be used in combination with other medicines called ciclosporin and corticosteroids, to prevent your body rejecting a new kidney, liver or heart following a transplant.
2. What you need to know before you take Mycophenolate Tablets
Do not take Mycophenolate Tablets if you are:
• allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any other ingredients in Mycophenolate Tablets (see section 6, Further information)
• breast-feeding.
Warnings and precautions
Tell your doctor immediately if you notice any of the following whilst taking Mycophenolate Tablets:
• signs of an infection (e.g. fever, sore throat, aches and pain)
• unexpected bruising and/or bleeding
• If you are planning to become pregnant, or if you get pregnant while taking Mycophenolate Tablets
• If you have or ever have had any problems with your digestive system, e.g., stomach ulcers.
Talk to your doctor before taking Mycophenolate Tablets if you:
• suffer from either Lesch-Nyhan or Kelley-Seegmiller syndrome.
Mycophenolate Tablets can increase the risk of you getting cancer, particularly skin cancer, as it reduces your body's defence mechanism. To reduce the risk of skin cancer, exposure to sunlight and UV light should be avoided by wearing protective clothing and using a sunscreen with a high protection factor.
Other medicines and Mycophenolate Tablets
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Mycophenolate Tablets:
• medicines used to treat herpes and shingles, such as aciclovir, valaciclovir and ganciclovir
• medicines called antacids, or proton pump inhibitors used to relieve heartburn, acid reflux and indigestion
• medicines used to treat cholesterol such as cholestyramine
• antibiotics such as rifampicin
• medicines called immunosuppresants, such as sirolimus and tacrolimus, which are given to some patients who have had an organ transplant to prevent rejection
• medicines used to reduce the absorption of phosphate in patients with chronic renal failure, such as sevelamer
• medicines used to treat infections, such as
norfloxacin and metronidazole
• medicines used to treat gout, such as probenecid
• live vaccines should not be given.
Tell your doctor if you need to have any vaccinations whilst you are taking Mycophenolate Tablets. You will be told which ones you can have.
Mycophenolate tablets with food and drink
Taking food and drink has no influence on your treatment with Mycophenolate Tablets.
Pregnancy and breast-feeding
Taking Mycophenolate Tablets during pregnancy may cause miscarriage or damage to your unborn baby (abnormal development of ears for example). In certain situations, you and your doctor may decide that the benefits of taking Mycophenolate Tablets for your health are more important than the possible risks to your unborn baby. If you plan to become pregnant, speak to your doctor about other medicines to best prevent rejection of your transplanted organ. If you become pregnant while taking Mycophenolate Tablets, do not stop taking it, but tell your doctor about your pregnancy as soon as possible.
Do not take Mycophenolate Tablets if you are:
• Breast-feeding
• Pregnant (unless your doctor clearly tells you)
Tell your doctor straight away if:
• You think you may be pregnant
• You are breast-feeding
• You plan to start a family in the near future
You must always use an effective method of birth control:
• Before you start taking Mycophenolate Tablets
• During your entire treatment with Mycophenolate Tablets
• For six weeks after you stop taking Mycophenolate Tablets
Talk to your doctor about the most suitable methods for birth control for you based on your individual situation. Women who are capable of becoming pregnant must have a negative pregnancy test BEFORE starting treatment with Mycophenolate Tablets.
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 uterus has been surgically removed (hysterectomy).
• You have premature failure of the ovaries, confirmed by a 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.
Driving and using machines
Mycophenolate Tablets are not known to affect your ability to drive or use machines.
3. How to take Mycophenolate Tablets
Always take Mycophenolate Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your dose will depend on the type of transplant you have had. The usual doses are as follows:
Kidney Transplant
Adults: Your first dose will be given to you within 72 hours of your transplant operation. The usual dose is:
• two tablets twice a day (2g daily dose).
Elderly (65 years and over): The usual dose is two tablets twice a day.
Children (aged two to 18 years): The dose given will depend on the size of your child. Your doctor will determine the suitable dose based on the height and weight of your child. The usual dose is:
• 600mg/m2 taken as two tablets twice a day (maximum of 2g daily dose)
Mycophenolate Tablets are not recommended for children under two years old.
Heart Transplant
Adults: Your first dose will be given to you within five days after your transplant operation. The usual dose is:
• Three tablets twice a day (3g daily dose)
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Elderly (65 years and over): The usual dose is three tablets twice a day.
Children: Mycophenolate Tablets are not recommended for use in children, as there are no data available on their use in children who have had a heart transplant.
Liver Transplant
Adults: Your first dose will be given to you four days after your transplant operation, and as soon as you can tolerate them. The usual dose is:
• Three tablets twice a day (3g daily dose)
Elderly (65 years and over): The usual dose is three tablets twice a day.
Children: Mycophenolate Tablets are not recommended for use in children, as there are no data available on their use in children who have had a liver transplant.
Take Mycophenolate Tablets with a glass of water. Do not crush or chew them.
Your doctor will give you regular blood tests during your first year of treatment with Mycophenolate Tablets to check that they are not affecting you badly.
If you take more Mycophenolate Tablets than you should
If you accidentally take too many tablets, you should contact your doctor or go to your nearest hospital casualty department immediately. Take this leaflet and any unused tablets with you to show the doctor.
If you forget to take Mycophenolate Tablets
If you forget to take your medicine take it as soon as you remember. If it is almost time for your next dose do not take the missed dose at all. NEVER take a double dose to make up for the one missed.
Do not stop taking Mycophenolate Tablets unless your doctor tells you to, as you may increase the chances of your body rejecting the transplanted organ.
If you are not sure or have any other questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines Mycophenolate Tablets can cause side effects, although not everybody gets them.
Mycophenolate Tablets suppresses your body's immune system so that your body does not reject the transplanted organ. You may therefore be more susceptible to infections of the:
• brain
• skin
• mouth, nose or throat
• stomach and intestines
• lungs or respiratory tract
• urinary tract.
Tell your doctor straight away if you notice any signs of infection.
If you have an allergic reaction to Mycophenolate Tablets, tell your doctor straight away. The signs of an allergic reaction include:
• swelling of your face
• low blood pressure (feeling faint, dizzy or light headed)
• difficulty breathing.
Mycophenolate Tablets can increase the risk of you getting cancer, particularly skin cancer. A very small number of patients have developed cancer of the lymphoid tissues.
The other side effects that have been reported with Mycophenolate Tablets are:
Very common (affects more than 1 in 10 people)
• reduction in blood platelets, which increases risk of bruising or bleeding
• feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia.
• feeling sick (nausea), being sick (vomiting) stomach pains or diarrhoea
Common (affects more than 1 in 100 people)
• pneumonia (lung infection)
• bronchitis (inflammation of the air passages to the lungs
• fluids on the lungs/chest cavity
• sinus problems
• fungal infection, such as thrush
• thickening of the skin
• cold sores, shingles, acne, rash
• hair loss (alopecia)
• weakness, bruising, or infections. These could be symptoms of a blood disorder called pancytopenia
• too much uric acid in the blood, or gout
• high blood sugar
• too little calcium in the blood
• too little magnesium in the blood
• too much fat or cholesterol in the blood
• too little phosphate in the blood
• weight loss (anorexia)
• feeling confused, excited, depressed, restless, anxious
• feeling drowsy or sleepy, or have difficulty sleeping
• convulsions (fits), tremors, dizziness, headache
• unusual feelings such as numbness,
tingling, pricking, burning or creeping of the skin (paraesthesia)
• muscle spasms
• change to the way things taste
• increased or rapid heartbeat
• high or low blood pressure
• difficulty breathing, shortness of breath or a 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.
• difficulty swallowing , stomach ulcers, indigestion, wind, constipation
• kidney disease, liver disease, yellowing of the skin or whites of the eyes (jaundice)
• feeling tired, weak or a general feeling of being unwell
• chills and pains
• severe stomach pain which may reach through to your back. This could be a sign of pancreatitis.
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. You can also report side effects directly via the Yellow Card scheme at: www.mhra.qov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Mycophenolate Tablets
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the original container in order to protect from light.
Do not use Mycophenolate Tablets after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
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. Contents of the pack and other information
What Mycophenolate Tablets contain The active ingredient is: mycophenolate mofetil. Each Mycophenolate Tablet contains 500mg of mycophenolate mofetil.
The other ingredients are:
• Tablet core: microcrystalline cellulose (E460(i)), croscarmellose sodium, povidone, hydroxypropylcellulose (E463), magnesium stearate.
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, purified talc (E553b), indigo carmine aluminium lake (E132), red iron oxide (E172).
What Mycophenolate Tablets look like and contents of the pack
Mycophenolate tablets are purple coloured film coated tablets engraved with W417' on one side and plain on the other.
Mycophenolate Tablets are available in blister packs packaged in a cardboard carton, containing 50 tablets.
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK.
Manufacturer:
CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only).
Please be ready to give the following information:
|
Product name |
Reference number |
|
Mycophenolate Mofetil 500 mg Film-Coated Tablets |
29831/0427 |
This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call +44 1978 669272.
This medicinal product is authorised in the following Member States in the EEA, under the following names:
Cyprus - Mycophenolate Mofetil Wockhardt
500 mg Film-Coated Tablets
Poland - Wockhardt Mycophenolate Mofetil
Republic of Ireland - Mycophenolate Mofetil
500 mg Film-Coated Tablets
United Kingdom - Mycophenolate Mofetil 500
mg Film-Coated Tablets
Leaflet prepared: December 2014.