Mycophenolate Mofetil 500 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FORTHE USER
MYCOPHENOLATE MOFETIL 500 mg FILM-COATEDTABLETS
(mycophenolate mofetil)
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Mycophenolate Tablets are and what they are used for.
2. Before you take Mycophenolate Tablets.
3. How to take Mycophenolate Tablets.
4. Possible side effects.
5. How to store Mycophenolate Tablets.
6. Further information.
1. WHAT MYCOPHENOLATE TABLETS ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is Mycophenolate mofetil 500 mg film-coated tablets:
• In this leaflet the shorter name Mycophenolate Tablets is used.
Mycophenolate Tablets contain mycophenolate mofetil:
• This belongs to a group of medicines called 'immune-suppressants'.
Mycophenolate Tablets are used to prevent your body rejecting a transplanted organ:
• A kidney, heart or liver.
Mycophenolate Tablets are used together with other medicines:
• ciclosporin
• corticosteroids.
2. BEFORE YOU TAKE MYCOPHENOLATE TABLETS
Do not take Mycophenolate Tablets if:
• you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of Mycophenolate Tablets (listed in Section 6)
• you are pregnant or breast-feeding.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Mycophenolate Tablets.
Take special care with Mycophenolate Tablets
Talk to your doctor straight away before taking Mycophenolate Tablets 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 any problems with your digestive system such as a stomach ulcer
• you are planning to become pregnant or if you get pregnant while taking Mycophenolate Tablets.
If any of the above apply to you (or you are not sure) talk to your doctor straight away before taking Mycophenolate Tablets.
The effect of sunlight
Mycophenolate Tablets reduces your body's defences As a result, there is an increased risk of skin cancer. Limit the amount of sunlightand UVlightyou get. Do this by:
• wearing protective clothing which also covers your head, neck, arms and legs
• using a sunscreen with a high protection factor.
Taking other medicines
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 Tablets can affect the way some other medicines work. Also other medicines can affect the way Mycophenolate Tablets works.
In particular, tell your doctor or pharmacist if you are taking any of the following Medicines before you start Mycophenolate Tablets:
• azathioprine or other medicines which may 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 Tablets, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.
Taking Mycophenolate Tablets with food and drink:
Taking food and drink has no effect on your treatment with Mycophenolate Tablets.
Pregnancy, contraception and breast-feeding
Pregnancy
If you are pregnant, do nottake Mycophenolate Tablets. This is because Mycophenolate Tablets may cause miscarriage or damage to your unborn baby (affecting development of ears for example):
• 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.
* 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 thinkyou may be pregnant tell your doctor straight away.
* However, keep taking Mycophenolate Tablets until you see him or her.
If you are able to become pregnant, you must have a pregnancy test before you start Mycophenolate Tablets. You can only start Mycophenolate Tablets 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 you r 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, Turners 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 Tablets. This includes:
• before you start taking Mycophenolate Tablets
• during your entire treatment with Mycophenolate Tablets
• for 6 weeks after you stop taking Mycophenolate Tablets. Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation.
Breast-feeding
Do not take Mycophenolate Tablets if you are breastfeeding.This is because small amounts of the medicine can pass into the mother's milk.
Driving and using machines
Mycophenolate Tablets is not likely to affect you being able to drive or use any tools or machines.
3. HOWTOTAKEMYCOPHENOLATETABLETS
Always take Mycophenolate Tablets 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 you r 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 18years):
• 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 Tablets in children with a heart transplant.
Liver transplant
Adults:
• The first dose of oral Mycophenolate Tablets 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 Tablets in children with a liver transplant.
Taking the medicine:
• Swallow your tablets whole with a glass of water.
• Do not break or crush them.
If you take more Mycophenolate Tablets than you should
If you take more Mycophenolate Tablets than you shoud talk to or 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 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 Tablets
Do not stop taking Mycophenolate Tablets unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplanted organ.
If you have any further questions on the use of this product askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mycophenolate Tablets 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 Tablets reduces 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 Tablets 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
• fluid on the lungs or inside the chest
• sinus problems.
Other problems such as:
• weight loss, gout, high blood sugar, bleeding, bruising.
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. HOWTO STORE MYCOPHENOLATETABLETS
Keep out of reach and sight of children. Do not store above 30°C. Keep in outer carton to protect from light.
Do not use Mycophenolate Tablets after the expiry date which is stated on the carton after 'EXP'.
The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste.
Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Mycophenolate Tablets contains
Each tablet contains 500 mg of Mycophenolate mofetil (the active ingredient, which makes the tablets work).
The other ingredients are: microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate. The tablet coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), macrogol, indigo carmine aluminium lake (E132) and red iron oxide (E172).
What Mycophenolate Tablets look like and contents of the pack
Mycophenolate Tablets are lavender coloured, capsule shaped, film-coated tablets marked with 'RDY' on one side and '585' on the other side. They are available in packs of 50,100 or 150 tablets.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD.
Distributed by Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
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This leaflet was last revised in 09/2012 1 0004 8 78