Glivec 400 mg Imatinib Mesilate Tablets

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.

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”.