Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
Pharmacare Premium Limited HHF 003 Halfar Industrial Estate Birzebbugia BBG 3000, Malta
L01EX01
SUNITINIB 12.5 mg
HARD CAPSULE
SUNITINIB 12.5 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-06-20
Page 1 of 10 PACKAGE LEAFLET Page 2 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER SUNITINIB PHARMACARE 12.5 MG HARD CAPSULES SUNITINIB PHARMACARE 25 MG HARD CAPSULES SUNITINIB PHARMACARE 37.5 MG HARD CAPSULES SUNITINIB PHARMACARE 50 MG HARD CAPSULES sunitinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Sunitinib Pharmacare is and what it is used for 2. What you need to know before you take Sunitinib Pharmacare 3. How to take Sunitinib Pharmacare 4. Possible side effects 5. How to store Sunitinib Pharmacare 6. Contents of the pack and other information 1. WHAT SUNITINIB PHARMACARE IS AND WHAT IT IS USED FOR Sunitinib Pharmacare contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells. Sunitinib Pharmacare is used to treat adults with the following types of cancer: - Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib. - Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to others parts of the body. - Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery. If you have any questions about how Sunitinib Pharmacare works or why this medicine has been prescribed for you, ask you Leggi il documento completo
Page 1 of 33 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 33 1. NAME OF THE MEDICINAL PRODUCT Sunitinib Pharmacare 12.5 mg hard capsules Sunitinib Pharmacare 25 mg hard capsules Sunitinib Pharmacare 37.5 mg hard capsules Sunitinib Pharmacare 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 12.5 mg hard capsules Each capsule contains 12.5 mg of sunitinib 25 mg hard capsules Each capsule contains 25 mg of sunitinib 37.5 mg hard capsules Each capsule contains 37.5 mg of sunitinib 50 mg hard capsules Each capsule contains 50 mg of sunitinib For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Sunitinib Pharmacare 12.5 mg hard capsules Hard gelatin capsule size ‘4’ with orange cap and orange body, printed with white ink ‘SB 12.5’ and white line on the body and containing yellow to orange granules. Sunitinib Pharmacare 25 mg hard capsules Hard gelatin capsule size ‘3’ with caramel cap and orange body, printed with white ink ‘SB 25’ and white line on the body and containing yellow to orange granules. Sunitinib Pharmacare 37.5 mg hard capsules Hard gelatin capsule size ‘2’ with yellow cap and yellow body, printed with black ink ‘SB 37.5’ and black line on the body and containing yellow to orange granules. Sunitinib Pharmacare 50 mg hard capsules Hard gelatin capsule size ‘1’ with caramel cap and caramel body, printed with white ink ‘SB 50’ and white line on the body and containing yellow to orange granules. Page 3 of 33 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastrointestinal stromal tumour (GIST) Sunitinib Pharmacare is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Pharmacare is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Pharmacare is indicat Leggi il documento completo