Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
CAPECITABINE
Fresenius Kabi Oncology Plc
L01BC06
CAPECITABINE
500 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
capecitabine
Not Marketed
2012-11-09
CAPECITABINE - PACK INSERT - IRL+GBR (Travesh Sharma) D:\Europe\Capecitabine\Ireland + UK\28 Nov 2013\Capecitabine - Pack Insert - IRL+GBR.indd SIZE: 450 X 210 MM 4 AUGUST 2014 10:27 AM VER. 09 TIMES NEW ROMAN 8 PTS. Black xxxxx xxxxxxxxxx V004 CAPECITABINE FILM-COATED TABLETS xxxxxx / xxxxxxxxxx / V004 TEMP CAPECITABINE FILM-COATED TABLETS xxxxxx / xxxxxxxxxx / V004 TEMP PACKAGE LEAFLET: INFORMATION FOR THE USER CAPECITABINE 150 MG FILM-COATED TABLETS CAPECITABINE 500 MG FILM-COATED TABLETS 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. IN THIS LEAFLET: 1.-- What-Capecitabine-is-and-what-it-is-used-for 2.-- What-you-need-to-know-before-you-take-Capecitabine 3.-- How-to-take-Capecitabine 4.-- Possible-side-effects 5.-- How-to-store-Capecitabine 6.-- Contents-of-the-pack-and-other-information 1. WHAT CAPECITABINE IS AND WHAT IT IS USED FOR Capecitabine-belongs-to-the-group-of-medicines-called-“cytostatic-medicine”,-which- stop-the-growth-of-cancer-cells.--Capecitabine-film-coated-tablets-contains-150-mg- or-500-mg-capecitabine,-which-itself-is-not-a-cytostatic-medicine.-Only-after-being- absorbed-by-the-body-is-it-changed-into-an-active-anti-cancer-agent-(more-in-tumour- tissue-than-in-normal-tissue). Capecitabine--is-used-in-the-treatment-of-colon,-rectal,-gastric,-or-breast-cancers.- Furthermore,-capecitabine-is-used-to-prevent-new-occurrence-of-colon-cancer-after- complete-removal-of-the-tumour-by-surgery. Capecitabine-may-be-used-either-alone-or-in-combination-with-other-agents. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPE Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capecitabine 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg capecitabine. Excipient (s) with known effect: 41 mg lactose monohydrate (500 mg tablet). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pink coloured, capsule shaped, biconvex, film coated tablets, 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 platinum-based 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 anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Capecitabine should only be prescribed by a qualified physician experienced in the utilisation of anti- neoplasticmedicinal products. Careful monitoring during the first cycle of treatment is recommended for all patients. Treatment should be discontinued if progressive disease or intolerable toxicity is observed. Standard and reduced dose calculations according to body surface area for starting doses of capecitabine of 1250 mg/m 2 and 1000 mg/m 2 are provided in tables 1 and 2, respectively. Posology Recommended posology (see section 5.1) Monotherapy _Colon, Lees het volledige document