MYFORTIC
Film-coated gastro-resistant tablets (mycophenolic acid)
Myfortic 180mg and 360mg film-coated gastro-resistant tablets
mycophenolic acid (as mycophenolate sodium)
Patient Information Leaflet
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 further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
In this leaflet
- 1. What Myfortic is and what it is used for
- 2. Before you take Myfortic
- 3. How to take Myfortic
- 4. Possible side effects
- 5. Storing Myfortic
- 6. Further information
Myfortic 180mg and 360mg film-coated gastro-resistant tablets
The active substance in Myfortic is mycophenolic acid. Myfortic 180mg film-coated gastro-resistant tablets contain 180mg mycophenolic acid (as mycophenolate sodium). Myfortic 360mg film-coated gastro-resistant tablets contain 360mg mycophenolic acid (as mycophenolate sodium).
The other ingredients of the tablet are: maize starch, povidone, crospovidone, lactose anhydrous, silica colloidal anhydrous, magnesium stearate. The tablet coating contains: hypromellose phthalate, titanium dioxide (E171), iron oxide yellow (E172).
The 180mg tablets also contain indigo carmine (E132).
The 360mg tablets also contain iron oxide red (E172).
Marketing Authorisation Holder
Manufacturer responsible for release onto the market
What Myfortic is and what it is used for
Myfortic film-coated gastro-resistant tablets belong to the class of drugs known as immunosuppressants. Immunosuppressants reduce your body's response to anything that it sees as "foreign" - which includes transplant organs.
Myfortic 180mg film-coated gastro-resistant tablets are lime green, film-coated round tablets, with the imprint "C" on one side. Myfortic 360mg film-coated gastro-resistant tablets are pale orange/red, film-coated ovoid tablets, with the imprint "CT" on one side.
Myfortic comes in the following pack sizes:
- 180mg tablets: cartons containing 20,50,100,120 or 250 tablets.
- 360mg tablets: cartons containing 50, 100, 120 or 250 tablets.
Not all pack sizes may be marketed.
Myfortic is used to prevent your body from rejecting your kidney transplant. Myfortic is used together with other drugs known as ciclosporin and corticosteroids.
If you have any questions about how Myfortic works or why this medicine has been prescribed for you, ask your doctor.
Before you take Myfortic
Myfortic will only be prescribed for you by a doctor with experience in transplantation medicine. Follow your doctor's instructions carefully.
Do not take Myfortic:
If you are allergic (hypersensitive) to mycophenolic acid, mycophenolate sodium or mycophenolate mofetil or to any of the ingredients of Myfortic listed at the beginning of this leaflet.
Take special care with Myfortic:
If the answer to any of the following questions is 'yes', talk to your doctor before you start to take Myfortic:
- Do you now, or have you ever had any problems with your digestive system, e.g., stomach ulcers?
- Do you need to receive vaccines (especially live vaccines)? It is important to seek your doctor's advice first.
- If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose).
- If you know that you have a hereditary enzyme deficiency such as Lesch-Nyhan or Kelley-Seegmiller syndrome.
In case of any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding you should inform your doctor immediately.
Myfortic reduces your body's defence mechanism. Because of this, there is an increased risk of skin cancer. You should therefore limit your exposure to sunlight and UV light by covering exposed areas as much as possible, wearing a hat when there is a risk of burning, and using sunscreen with a high protection factor.
Myfortic and older people
Myfortic can be given to older people.
Myfortic in children and adolescents
There is not enough experience to recommend the use of Myfortic in children and adolescents.
Pregnancy and Breast-feeding
If you are a woman you should make sure that you are not pregnant e.g. by means of a negative pregnancy test, before you start taking Myfortic. Your doctor should advise you about contraception before starting Myfortic, whilst taking it and for six weeks after you have stopped taking it. This is because Myfortic may cause damage to your unborn baby.
Tell your doctor straight away if you are pregnant, breast feeding, become pregnant, or plan to start a family in the near future.
Driving and using machines:
Myfortic is unlikely to affect your ability to drive or use machines.
Taking other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you have bought without a prescription.
In particular, you should inform your doctor if you are taking any of the following:
- Azathioprine (another immunosuppressant)
- Tacrolimus (another immunosuppressant)
- Any other immunosuppressive agents other than ciclosporin and corticosteroids.
- Colestyramine (used to treat patients with high blood cholesterol and certain other disorders)
- Antacids
- Aciclovir or ganciclovir (used for viral infections).
Your dose of Myfortic may need to be adjusted if your doctor considers it necessary for you to interrupt or stop taking ciclosporin therapy. Your doctor should discuss this with you.
You should tell your doctor if you plan to receive any vaccinations (see Take Special Care with Myfortic section)
How to take Myfortic
Follow your doctor's instructions carefully. Do not exceed the recommended dosage.
Do not stop taking Myfortic unless your doctor tells you to.
How much to take
If you have just had your transplant, then the first dose of 720mg will be given to you within 72 hours of your transplant operation.
The recommended daily dose is 1440mg. This is taken as two separate doses of 720mg each.
If you are taking 180mg tablets
: This means taking 4 tablets each morning and 4 tablets each evening.
If you are taking 360mg tablets
: This means taking 2 tablets each morning and 2 tablets each evening.
How to take Myfortic
Swallow the tablets whole with a glass of water. Do not break or crush them and do not take any tablets that are broken or split.
You can take Myfortic either with food or without food. You should choose one of these options and continue to take it in this way to make sure that absorption of your medication is consistent.
How long to take Myfortic
Usually treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplant. You should follow the advice of your doctor.
If you take more Myfortic than you should:
If you take more tablets than you have been told to take, or if someone else accidentally takes your medicine, tell your doctor immediately or go straight to your nearest Casualty Department.
If you forget to take Myfortic:
If you forget to take Myfortic, take it as soon as you remember unless it is almost time for your next dose. Then continue to take your tablets at the usual times.
Effects when treatment with Myfortic is stopped:
Stopping your treatment with Myfortic may increase the chance of rejection of your transplant. Do not stop taking your medicine unless your doctor tells you to.
Possible side effects
Like all medicines, Myfortic can have side effects, even when used as directed. Most of these are similar to those you would have with other mycophenolic acid compounds such as mycophenolate mofetil. Some of the more usual problems include diarrhoea and fewer white cells in your blood.
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, and cholesterol.
Myfortic reduces your body's own defence mechanisms to stop you rejecting your transplant. Consequently your body will not be as good as normal at fighting infections. So if you are taking Myfortic you may be at increased risk of infections caused by bacteria, viruses or fungi. These may include infections of wounds, blood, bones, chest, heart or brain. Some infections may be life threatening.
As with other immunosuppressive medications, there is an increased risk of developing certain types of cancer whilst taking Myfortic. Skin cancer may become apparent as unexpected growths that may be shiny or ulcerating, and cancer of the white blood cells may appear as swollen glands (lymph nodes).
Other effects may include:
General symptoms including tiredness, fever, flu-like illness, swelling in your lower limbs, thirst, chills, pain and weakness.
Disorders of the mouth such as bad breath, tongue discolouration, dry mouth and gum overgrowth.
Disorders of the digestive system including loose stools, constipation, nausea, vomiting, abdominal swelling, pain or tenderness, heartburn, indigestion, flatulence, inflammation, bleeding, lip and stomach ulcers, salivary gland blockage and inflammation of the pancreas.
Disorders of the nervous system including headache, tremor and difficulty sleeping.
Disorders of the skin including hair loss and bruising.
Urinary disorders such as kidney problems, blood in the urine or difficulty passing urine.
Disorders of the blood and vascular disorders including reduced numbers of white cells, red cells and platelets and swollen glands.
Metabolic disorders such as weight loss, high levels of lipids or cholesterol in your blood, low levels of phosphate or diabetes.
Disorders of the lung or respiratory system including cough, wheezing, fluid on the lungs, infections and pneumonia.
Disorders of the heart including abnormal heart beat.
Other side effects that have been reported include abnormal tests of liver function, blurred vision, conjunctivitis, impotence, back pain, muscle cramps, strange dreams, delusions and arthritis.
If any of these affects you, tell your doctor. If you notice any other side effects not mentioned in this leaflet, please inform your doctor. However, do not stop taking your medicine unless you have discussed this with your doctor first.
Storing Myfortic
- Do not store Myfortic above 30°C.
- Store Myfortic in the original package in order to protect from moisture and light.
- Do not use Myfortic after the expiry date printed on the box.
- Do not use any Myfortic pack that is damaged or shows signs of tampering.
- Keep Myfortic out of the reach and sight of children.
- If your doctor decides to stop your treatment, return any leftover medicine to the Pharmacist. Only keep it if your doctor tells you to.
Further Information
Leaflet approved: November 2007
Myfortic 180mg film-coated gastro-resistant tablets: PL 00101/0664
Myfortic 360mg film-coated gastro-resistant tablets: PL 00101/0665
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