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Matinab

Imatinib

Film-coated tablets

Active ingredient: Each Matinab tablet contains Imatinib mesylate.

Drug form: Film-coated tablet

Matinab is a treatment for adults and children for:

- Chronic myeloid leukemia (CML).

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

Matinab is a treatment for adults for:

- Myelodysplastic/myeloproliferative diseases (MDS/MPD).

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

- Gastrointestinal stromal tumors (GIST).

- Dermatofibrosarcoma protuberans (DFSP).

If you have any questions about how Matinab works or why this medicine has been prescribed for you, ask your doctor.

Mechanism of action:

Matinab is a protein-tyrosine kinase inhibitor that inhibits the bcr-abl tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality. It inhibits proliferation and induces apoptosis in bcr-abl positive cell lines.

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What you need to know before you take Matinab

Matinab should be taken exactly as prescribed by your doctor.

Follow all your doctor’s instructions carefully, even if they differ from the general information contained in this leaflet.

Warnings and precautions:

Talk to your doctor before taking Matinab.

Take special care with Matinab:

- if you have or have ever had a liver, kidney or heart problem.

- if you are taking the medicine levothyroxine because your thyroid has been removed.

- if you have ever had or might now have a hepatitis B infection. This is because Matinab could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

-You may become more sensitive to the sun while taking Matinab. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF).

-You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.

- During treatment with Matinab, tell your doctor straight away if you put on weight very quickly or have swelling.

- Talk with your doctor before getting any vaccines.

- You will also have blood tests and be weighed regularly.

- Some children and adolescents taking Matinab may have slower than normal growth. The doctor will monitor the growth at regular visits.

- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol), chemical drugs (such as warfarin) and herbal medicines.

Pregnancy, breast-feeding and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Matinab is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Matinab during pregnancy.

Women who might become pregnant are advised to use effective contraception during treatment.

Do not breast-feed during the treatment with Matinab.

Children and adolescents:

Matinab is also a treatment for children with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Driving and using machines:

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

Contraindications:

- If you are allergic to imatinib.

How to take Matinab
Possible side effects
How to store Matinab
Contents of the pack and other information
How to dispose Matinab

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