Land: Malta
Sprog: engelsk
Kilde: Malta Medicines Authority
CAPECITABINE
ALFRED E. TIEFEMBACHER (GmbH &Co. KG) Van-der-Smissen-Straße 1, 22767 Hamburg, Germany
L01BC06
CAPECITABINE 150 mg
FILM-COATED TABLET
CAPECITABINE 150 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2013-04-30
PACKAGE LEAFLET: INFORMATION FOR THE USER BINODA150 MG FILM-COATED TABLETS BINODA 500 MG FILM-COATED TABLETS capecitabine 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. WHAT IS IN THIS LEAFLET: 1. What BINODA is and what it is used for 2. What you need to know before you take BINODA 3. How to take BINODA 4. Possible side effects 5. How to store BINODA 6. Contents of pack and other information 1. WHAT BINODA IS AND WHAT IT IS USED FOR BINODA belongs to the group of medicines called "cytostatic agents", which stop the growth of cancer cells. BINODA contains 150 mg/500 mg capecitabine, which itself is not a cytostatic agent. Only after being absorbed by the body is it changed into an active anti-cancer agent (more in tumour tissue than in normal tissue). BINODA is prescribed by doctors for the treatment of colon, rectal, gastric, or breast cancers. Furthermore, BINODA is prescribed by doctors to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. BINODA may be used either alone or in combination with other agents. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BINODA DO NOT TAKE BINODA: - if you are allergic to capecitabine, flourouracil or any of the other ingredients of this medicine (listed in section 6). - You must inform your doctor if you know that you have an allergy or over-reaction to BINODA or to flouropyrimidin Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BINODA 150 mg film-coated tablets. BINODA 500 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [For 150 mg strength:] Each film-coated tablet contains 150 mg capecitabine. Excipient with known effect: 12.3 mg lactose monohydrate. [For 500 mg strength:] Each film-coated tablet contains 500 mg capecitabine. Excipient with known effect: 41 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet [For 150 mg strength:] Pink coloured, capsule shaped, biconvex, film coated tablets (approx. 11.1 mm x 5.6 mm), debossed with “150”on one side and plain on other side. [For 500 mg strength:] Pink coloured, capsule shaped, biconvex, film coated tablets (approx. 17.1 mm x 8.1 mm), debossed with “500’ on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). Capecitabine is indicated for the treatment of metastatic colorectal cancer (see section 5.1). Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinumbased regimen (see section 5.1). Capecitabine in combination with docetaxel (see section 5.1) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracyclinecontaining chemotherapy regimen or for whom further anthracycline therapy is not indicated. Page 1 of 21 4.2 PO Læs hele dokumentet