Mycophenolate Mofetil 500 Mg Film-Coated Tablets
Out of date information, search anotherPackage leaflet:
Information for the user
Mycophenolate Mofetil 500 mg film-coated tablets
Mycophenolate mofetil
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
oryou.
• 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.
What is in this leaflet:
1. What Mycophenolate Mofetil is and what it is used for
2. What you need to know before you take Mycophenolate Mofetil
3. Howtotake Mycophenolate Mofetil
4. Possible side effects
5. How to store Mycophenolate Mofetil
6. Contents of the pack and other information
1. What Mycophenolate Mofetil is and what it is used for
Mycophenolate Mofetil contains the active ingredient mycophenolate mofetil which is one group of drugs known as immunosuppressant agents. Immunosuppressants are used to prevent rejection of transplanted organs, and work by stopping your immune system from reacting to the transplanted organ.
Mycophenolate Mofetil may be used together with other medicines known as ciclosporin and corticosteroids.
2. What you need to know before you take Mycophenolate Mofetil
Do not take Mycophenolate Mofetil:
• if you are allergic (hypersensitive) to mycophenolate mofetil or any of the other ingredients of Mycophenolate Mofetil (listed in 'FURTHER INFORMATION').
• if you are breast-feeding or planing to breastfeed.
Warnings and precautions:
Tell your doctor if any of the following applies to you:
• if you thinkyou may have an infection (signs may include fever, chills, local inflammation, sore throat or ulcers in the mouth, but there could be other symptoms), any evidence of unexpected bruising or any unexpected bleeding.
• if you are suffering or have suffered from problems with your digestive system (such as ulcers or bleeding).
Mycophenolate Mofetil 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 a sunscreen with a high protection factor.
Other medicines and Mycophenolate Mofetil
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may interfere with Mycophenolate Mofetil. These medicines include:
• antacids, or proton pump inhibitors - a class of medicines for indigestion or heartburn
• azathioprine - is a drug used to suppress the body's own defence system
• cholestyramine (used to treat patients with high cholesterol)
• other immunosuppressants
• sevelamer used in patients with chronic renal failure to reduce the absorption of phosphate
• rifampicin an antibiotic use to treat infections
• vaccinations - as they may not be as effective as normal. Vaccination with live vaccines should be avoided.
Mycophenolate Mofetil with food and drink
Taking food and drink has no influence on your treatment with Mycophenolate Mofetil.
Pregnancy and breast-feeding
You must not use Mycophenolate Mofetil during pregnancy unless clearly indicated by your doctor. Your doctor should advise you about using contraception before taking Mycophenolate Mofetil, whilst taking Mycophenolate Mofetil, and for six weeks after you have stopped taking Mycophenolate Mofetil. This is because Mycophenolate Mofetil may cause damage, including problems with development of the ears, to your unborn baby. Tell your doctor straightaway if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future. 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.
Driving and using machines
Mycophenolate Mofetil has not been shown to impair your ability to drive or operate machinery.
3. Howtotake Mycophenolate Mofetil
Always take Mycophenolate Mofetil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is as follows:
Kidney Transplant
Adults:
The first dose will be given within 72 hours after the transplant operation. The recommended daily dose is 4 tablets (2 g of the active ingredient) taken as 2 separate doses. This means taking 2 tablets in the morning 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 body surface area (height and weight). The recommended dose is 600 mg/m2 taken twice a day.
Heart Transplant
Adults:
The first dose will be given within 5 days following the transplant operation. The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses. This means taking 3 tablets in the morning then 3 tablets in the evening.
Children:
No data are available to recommend the use of Mycophenolate Mofetil in children who have received a heart transplant.
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 medications. The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses. This means taking 3 tablets in the morning then 3 tablets in the evening.
Children:
No data are available to recommend the use of Mycophenolate Mofetil in children who have received a liver transplant.
Taking the medicine
The tablets should be swallowed whole with a glass of water.
If you take more Mycophenolate Mofetil than you should
Never take more than the recommended dose each day. If you or someone else swallows several of these tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.
If you forget to take Mycophenolate Mofetil
If you forget to take your medicine at any time, take it as soon as you remember unless it is almost time for your next dose then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Mycophenolate Mofetil
Always take Mycophenolate Mofetil exactly as your doctor has told you. Never stop taking your medicine or change the dose yourself, however well you feel unless you have discussed this with your doctor first. This is important to ensure yourtransplanted organ keeps working properly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Mycophenolate Mofetil can cause 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.
Mycophenolate Mofetil 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 Mycophenolate Mofetil you may therefore catch more infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract. As can happen in patients taking this type of medicine, a very small number of Mycophenolate Mofetil patients have developed cancer of the lymphoid tissues and skin.
Other unwanted effects may include:
Very Common affecting more than 1 in 10 people are:
• Blood poisoning
• Fungal infections of the gastrointestinal tract
• Urinary tract infection
• Herpes
• Shingles
• Sepsis
• Vomiting
• Abdominal pain
• Diarrhoea
• Nausea
• Reduced number of white and red blood cells and platelets
Common affecting less than 1 in 10 people are:
• Influenza
• Infections (including the airways)
• Fungal infections (including skin, airways, vagina)
• Skin cancer
• Constipation
• Indigestion
• Flatulence
• Belching
• Hepatitis
• Jaundice
• Increased level of bilirubin in the blood
• Acne
• Thickening of the skin
• Hair loss
• Rash
• Joint pain
• Renal problems or urgency to pass urine
• Swelling
• Fever
• Chills
• Pain
• Reduced blood cell count
• Increased white cell count
• Changes in the level of substances transported in the blood including sugar, fat, cholesterol, potassium and magnesium
• Depression
• Anxiety
• Changes in thoughts or mood swings
• Gout
• Inflammation (including the lungs, gastric mucosa, small intestine, bronchi, throat, nasal sinuses)
• Inflammation (peritoneum, stomach, large intestine, oesophagus, mucous membranes of the mouth)
• Sleeplessness
• Skin growths
• Gastric and intestinal bleeding
• Bowel obstruction
• Dizziness
• Muscle spasms
• Numbness ortingling of the skin
• Headaches
• Changes in the way things taste
• I ncrease heart rate
• Changes in blood pressure
• Widening of the blood vessels
• Fluid on the lungs/in the chest cavity
• Shortness of breath
• Cough
• Drowsiness
• Trembling
• Seizures(fits)
• Confusion
Uncommon affecting less than 1 in 100 people are:
• Inflammation (small intestine, pancreas)
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 www.yellowcard.mhra.gov.uk
5. Howto store Mycophenolate Mofetil
Keep out of the reach and sight of children.
Do not use Mycophenolate Mofetil after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Mofetil contains
The active substance is Mycophenolate mofetil.
The other ingredients are:
Tablet core:
microcrystalline cellulose povidone
croscarmellose sodium magnesium stearate silica collodial anhydrous
Tablet coating:
hypromellose hydroxypropyl cellulose titanium dioxide (E171) macrogol
yellow iron oxide (E172)
indigo carmine (E132) aluminium lake
What Mycophenolate Mofetil looks like and contents of the pack
Mycophenolate Mofetil are supplied as lavender caplet shaped tablets in blisters containing 50 or 150 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Momingside Healthcare Limited
115 Narborough Road
Leicester
LE30PA
U.K.
Sites responsible for batch release
Momingside Pharmaceuticals Ltd 5 Pavilion Way,
Loughborough.
Leicestershire
U.K
Monteresearch
Viale Vittorio Veneto 4, Milan
Italy
and
Sofarimex IndustriaQuimica, Lda.
Avenida Das Industrias
Avenida Das
Alto de Colaride, Agualva
2735-213 Cacem
Portugal
This leaflet was last revised in September 2013
10 3070 0 611949
