Country: Malta
Language: English
Source: Medicines Authority
DASATINIB
Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands
L01EA02
DASATINIB 20 mg
FILM-COATED TABLET
DASATINIB 20 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-05-18
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER DASATINIB SYNTHON 20 MG FILM-COATED TABLETS DASATINIB SYNTHON 50 MG FILM-COATED TABLETS DASATINIB SYNTHON 70 MG FILM-COATED TABLETS DASATINIB SYNTHON 80 MG FILM-COATED TABLETS DASATINIB SYNTHON 100 MG FILM-COATED TABLETS DASATINIB SYNTHON 140 MG FILM-COATED TABLETS dasatinib 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 Dasatinib Synthon is and what it is used for 2. What you need to know before you take Dasatinib Synthon 3. How to take Dasatinib Synthon 4. Possible side effects 5. How to store Dasatinib Synthon 6. Contents of the pack and other information 1 WHAT DASATINIB SYNTHON IS AND WHAT IT IS USED FOR Dasatinib Synthon contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age. Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. In people with CML, white cells called granulocytes start growing out of control. Dasatinib Synthon inhibits the growth of these leukaemic cells. Dasatinib Synthon is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age, and lymphoid blast CML in adults who are not benefiting from prior therapies. In people with ALL, white cells called lymphocytes multiply too quickly and live too long. Dasatinib Synthon inhibits the growth of these leukaemic cells. If you h Read the complete document
Page 1 of 41 1.3.1 Summary of Product Characteristics - Core 1. NAME OF THE MEDICINAL PRODUCT Dasatinib Synthon 20 mg film-coated tablets Dasatinib Synthon 50 mg film-coated tablets Dasatinib Synthon 70 mg film-coated tablets Dasatinib Synthon 80 mg film-coated tablets Dasatinib Synthon 100 mg film-coated tablets Dasatinib Synthon 140 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dasatinib Synthon 20 mg film-coated tablets Each film-coated tablet contains 20 mg of dasatinib. Excipient(s) with known effect Each film-coated tablet contains 28 mg of lactose monohydrate. Dasatinib Synthon 50 mg film-coated tablets Each film-coated tablet contains 50 mg of dasatinib. Excipient(s) with known effect Each film-coated tablet contains 69 mg of lactose monohydrate. Dasatinib Synthon 70 mg film-coated tablets Each film-coated tablet contains 70 mg of dasatinib. Excipient(s) with known effect Each film-coated tablet contains 97 mg of lactose monohydrate. Dasatinib Synthon 80 mg film-coated tablets Each film-coated tablet contains 80 mg of dasatinib. Excipient(s) with known effect Each film-coated tablet contains 111 mg of lactose monohydrate. Dasatinib Synthon 100 mg film-coated tablets Each film-coated tablet contains 100 mg of dasatinib. Excipient(s) with known effect Each film-coated tablet contains 138 mg of lactose monohydrate. Dasatinib Synthon 140 mg film-coated tablets Each film-coated tablet contains 140 mg of dasatinib. Excipient(s) with known effect Each film-coated tablet contains 194 mg of lactose monohydrate. Page 2 of 41 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Dasatinib Synthon 20 mg film-coated tablets White to off-white, biconvex, round film-coated tablet with a diameter of approximately 5.6 mm, with “D7SB” debossed on one side and “20” on the other side. Dasatinib Synthon 50 mg film-coated tablets White to off-white, biconvex, oval film-coated tablet with a length of approximately 11.0 mm and a width of approximately 6 Read the complete document