Country: Մալթա
language: անգլերեն
source: Medicines Authority
Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands
L01EK01
AXITINIB 3 mg
FILM-COATED TABLET
AXITINIB 3 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-02-02
M1.3.1_03.ATI.tab.001.06.MT.5475.01 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AXITINIB SYNTHON 1 MG FILM-COATED TABLETS AXITINIB SYNTHON 3 MG FILM-COATED TABLETS AXITINIB SYNTHON 5 MG FILM-COATED TABLETS AXITINIB SYNTHON 7 MG FILM-COATED TABLETS axitinib 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Axitinib Synthon is and what it is used for 2. What you need to know before you take Axitinib Synthon 3. How to take Axitinib Synthon 4. Possible side effects 5. How to store Axitinib Synthon 6. Contents of the pack and other information 1 WHAT AXITINIB SYNTHON IS AND WHAT IT IS USED FOR Axitinib Synthon is a medicine containing the active substance axitinib. Axitinib reduces the blood supply to the tumour and slows down the growth of cancer. Axitinib Synthon is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (called sunitinib or a cytokine) is no longer stopping disease from progressing. If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXITINIB SYNTHON DO NOT TAKE AXITINIB SYNTHON : If you are allergic to axitinib or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice. M1.3.1_03.ATI.tab.001.06.MT.5475.01 WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE TAKING AXITINIB SYNTHON - IF YOU HAVE HIGH BLOOD PRESSURE. read_full_document
1. NAME OF THE MEDICINAL PRODUCT Axitinib Synthon 1 mg film-coated tablets Axitinib Synthon 3 mg film-coated tablets Axitinib Synthon 5 mg film-coated tablets Axitinib Synthon 7 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Axitinib Synthon 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib. Axitinib Synthon 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib. Axitinib Synthon 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib. Axitinib Synthon 7 mg film-coated tablets Each film-coated tablet contains 7 mg of axitinib. Excipient(s) with known effect Axitinib Synthon 1 mg film-coated tablets Each film-coated tablet contains 33 mg of lactose monohydrate. Axitinib Synthon 3 mg film-coated tablets Each film-coated tablet contains 99 mg of lactose monohydrate. Axitinib Synthon 5 mg film-coated tablets Each film-coated tablet contains 166 mg of lactose monohydrate. Axitinib Synthon 7 mg film-coated tablets Each film-coated tablet contains 232 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Axitinib Synthon 1 mg film-coated tablets Red colour, round biconvex coated tablet, approximately 6 mm diameter and debossed with “A7TI” on one side and “1” on the other. Axitinib Synthon 3 mg film-coated tablets Red colour, oval biconvex coated tablet, approximately 12 mm long by 7 mm wide and debossed with “A7TI” on one side and “3” on the other. Axitinib Synthon 5 mg film-coated tablets Red colour, oval biconvex coated tablet, approximately 15 mm long by 8 mm wide and debossed with “A7TI” on one side and “5” on the other. Axitinib Synthon 7 mg film-coated tablets Red colour, oval biconvex coated tablet, approximately 17 mm long by 9 mm wide and debossed with “A7TI” on one side and “7” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Axitinib Synthon is indicated for the treatment of adult patients with advanced r read_full_document