Product Description:

• Glivec is a medicine that contains the active ingredient imatinib.


• This medicine works by inhibiting the growth of abnormal cells in the diseases listed below.


• This includes certain types of cancer.

Glivec is used to treat adults and children with:

Chronic myelogenous leukemia (CML):

• Leukemia is blood cancer that affects the white blood cells. 


• White blood cells usually help the body fight infections.


• Chronic myelogenous leukemia is a form of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to grow out of control.

Philadelphia chromosome positive acute lymphoblastic leukemia (Ph-positive ALL):

• Leukemia is a cancer that affects white blood cells. 


• These white blood cells usually help the body fight infections.


• Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow out of control.


• Glivec prevents the growth of these cells.

Glivec is also used to treat adults with:

Myelodysplastic/myeloproliferative diseases (MDS/MPD):

• This is a group of blood disorders where certain blood cells begin to grow out of control.


• Glivec prevents the growth of these cells in a specific subset of these diseases.

Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL):

• These are blood disorders in which some blood cells (called eosinophils ) begin to grow out of control. 


• Glivec prevents the growth of these cells in a specific subset of these diseases.

Gastrointestinal stromal tumors (GIST):

• Which is a form of cancer in the stomach and intestinal system.


• it is caused by uncontrolled cell growth in the supporting tissue in these organs.

Dermatofibrosarcoma protuberance (DFSP):

• DFSP is a form of cancer in the subcutaneous tissue, where certain cells begin to grow out of control.


• Glivec prevents the growth of these cells.


• In the rest of this package insert, the abbreviations will be used when the diseases are mentioned.


• Ask your doctor if you have any questions about how Glivec works or why this medicine has been prescribed for you.


• Glivec will only be prescribed to you by a doctor who has experience in using medicines to treat blood cancer or cancerous tumors called solid tumours.


• Follow all instructions from your doctor carefully,


• Even if they differ from the general information in this leaflet.

Do not use Glivec:

• If you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).


• If this applies to you, tell your doctor before using Glivec.


• Ask your doctor for advice if you think you may be allergic but are not sure.

How To Use:

• The doctor has prescribed Glivec because you suffer from a serious illness.


• Glivec can help fight this disease.


• Always use this medicine exactly as your doctor or pharmacist has told you.


• It is important that you do this for as long as the doctor or pharmacist tells you.


• Talk to your doctor or pharmacist if you are unsure.


• Do not stop treatment with Glivec unless your doctor tells you to. 


• If it is not possible to take the medicine as the doctor has told you, or you feel that you no longer need it, contact the doctor immediately.

How much Glivec should you take?

Use in adults:

• The doctor will tell you exactly how many tablets of Glivec to take.

If you are being treated for CML:

• Depending on your condition, the usual starting dose is either 400 mg or 600 mg, taken once a day.

If you are being treated for GIST:

• The starting dose is 400 mg, taken once a day.


• For CML and GIST, the doctor may prescribe a higher or lower dose depending on how you respond to the treatment. 


• If your daily dose is 800 mg, take 400 mg in the morning and 400 mg in the evening.

If you are being treated for Ph-positive ALL:

• The starting dose is 600 mg, taken once a day.

If you are being treated for MDS/MPD:

• The starting dose is 400 mg, taken once a day.

If you are being treated for HES/CEL:

• The starting dose is 100 mg, taken once a day.


• The doctor may decide to increase the dose to 400 mg, taken once a day, depending on how you respond to the treatment.

If you are being treated for DFSP:

• The dose is 800 mg/day, taken as 400 mg in the morning and 400 mg in the evening.


• A dose of 400 mg can be taken as either 1 tablet of 400 mg or 4 tablets of 100 mg. 


• A dose of 600 mg should be taken as 1 tablet of 400 mg and 2 tablets of 100 mg.

Use in children and adolescents:

• The doctor will tell you how many tablets of Glivec to give to your child. 


• The dose of Glivec will depend on the child's condition, body weight and height.


• The total daily dose in children should not exceed 800 mg for CML and 600 mg for Ph+ALL. 


• The treatment can either be given to your child as one daily dose or the daily dose can be divided into two doses (half in the morning and half in the evening).

When and how to use Glivec:

• Glivec should be taken with a meal. This will help protect against stomach problems when taking Glivec.


• The tablets are swallowed whole with a large glass of water.

If you are unable to swallow the tablets they can be dissolved in a glass of water or apple juice:

• Use approx. 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.


• Stir with a spoon until the tablets are completely dissolved.


• When everything is dissolved, drink the entire contents of the glass immediately. 


• There may be traces of dissolved tablets left in the glass.

How long Glivec should be used:

If you take too much Glivec:

• Contact a doctor immediately if you have accidentally taken too many tablets. 


• You may need medical follow-up. Take the package with the medicine with you.

If you have forgotten to take Glivec:

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, you should skip the missed dose.


• Then continue with your regular dosing schedule.


• You should not take a double dose to replace a missed dose.

Warnings And Precautions:

Talk to your doctor before using Glivec:

• If you have or have had liver, kidney or heart problems.


• If you are using the medicine levothyroxine because your thyroid gland has been removed.


• If you have, or have ever had, a hepatitis b infection ( inflammation of the liver caused by infection with the hepatitis b virus).


• This is because glivec can cause hepatitis b to become active again, which in some cases can be life-threatening. 


• Before treatment is started, you will be carefully examined by your doctor for signs of such an infection .


• If you develop bruising, bleeding, fever , fatigue and confusion while using glivec, contact your doctor. 


• This may be a sign of a type of damage to the blood vessels called thrombotic microangiopathy (tma).


• If any of these apply to you, tell your doctor before using Glivec .


• You may become more sensitive to sunlight when using Glivec. 


• It is important to cover skin that is exposed to sunlight and use sunscreen with a high sun protection factor.


• These precautions also apply to children.

During treatment with Glivec, tell your doctor straight away:

• If you experience rapid weight gain.


• Glivec can cause your body to start to retain water (severe fluid retention ).


• While you are using glivec, your doctor will regularly check whether the medicine is working. 


• Blood samples will also be taken from you and you will be weighed regularly.

Children And Youth:

• Glivec is also a treatment for children with CML. 


• There is no experience in children under 2 years of age with CML.


• There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.


• Certain children and adolescents who use Glivec may have slower growth than normal. 


• The doctor will monitor the growth regularly at doctor's visits.

Other medicines and Glivec:

• Talk to your doctor or pharmacist if you use, have recently used or plan to use other medicines, this also applies to non-prescription medicines (such as paracetamol), including natural medicines (such as St. John's wort). 


• Certain medicines can affect the effect of Glivec when taken at the same time. 


• They can increase or decrease the effect of Glivec, and can cause more side effects or make Glivec less effective.


• Glivec can have the same effect on certain other medicines.


• Talk to your doctor if you use medicines that prevent the formation of blood clots.

Pregnancy, breastfeeding and fertility:

• Talk to your doctor before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.


• Glivec is not recommended during pregnancy unless absolutely necessary, as it may harm your baby. The doctor will discuss the possible risks of using Glivec during pregnancy with you.


• Women who may become pregnant are advised to use effective contraception during treatment and for 15 days after treatment ends.


• You should not breast-feed during treatment and for 15 days after finishing treatment with Glivec, as it may be harmful to your child.


• Patients who are concerned about their fertility while using Glivec are advised to consult their doctor.

Driving and using machines:

• You may feel dizzy or drowsy or experience blurred vision when using this medicine. 


• If this happens, do not drive or use tools or machines until you feel well again.

How To Store Glivec:

• Keep out of reach of children.


• Do not use this medicine after the expiry date which is stated on the carton after exp.


• Storage temperature


• Glivec 100 mg film-coated tablets: store at a maximum of 30ºc.


• Glivec 400 mg film-coated tablets: store at a maximum of 25ºc.


• Store in the original packaging to protect against moisture.


• Do not use this medicine if you discover that the package is broken or shows signs of having been opened previously.


• Medicines must not be thrown into waste water or together with household waste. 


• Ask the pharmacy how to dispose of medicines that you no longer use. 


• These measures will help to protect the environment.

Ingredients:

The active substance is imatinib mesilate.

• Each Glivec 100 mg tablet contains 100 mg of imatinib (as mesilate).


• Each Glivec 400 mg tablet contains 400 mg of imatinib (as mesilate).

What Glivec looks like and the contents of the pack:

Glivec 100 mg film-coated tablets are:

• Dark yellow to brown-orange, round tablets. One side is marked "nvr", and the other side is marked "sa" and has a dividing line.

Glivec 400 mg film-coated tablets are:

• Dark yellow to brown-orange, oval tablets. One side is marked "glivec".

Product Details:

• Brand: Glivec
• Product Form: Tablets
• Product Type: Tablets