Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
capecitabine
Accord Healthcare Limited
L01BC06
capecitabine
150mg
tablets film-coated
(60/1x60/), in blister
Prescription
Registered
2015-12-11
PACKAGE LEAFLET: INFORMATION FOR THE USER CAPECITABINE ACCORD 150 MG FILM-COATED TABLETS CAPECITABINE ACCORD 300 MG FILM-COATED TABLETS CAPECITABINE ACCORD 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 Capecitabine Accord is and what it is used for 2. What you need to know before you take Capecitabine Accord 3. How to take Capecitabine Accord 4. Possible side effects 5. How to store Capecitabine Accord 6. Contents of the pack and other information 1. WHAT CAPECITABINE ACCORD IS AND WHAT IT IS USED FOR Capecitabine Accord belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Accord contains capecitabine, which itself is not a cytostatic medicine. Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue). Capecitabine Accord is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine Accord is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Capecitabine Accord may be used either alone or in combination with other medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE ACCORD DO NOT TAKE CAPECITABINE ACCORD • if you are allergic to capecitabine 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 overreaction to this medicine, • if you previously Read the complete document
2 1. NAME OF THE MEDICINAL PRODUCT Capecitabine Accord 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of capecitabine. Excipient(s) with known effect: Each film-coated tablet contains 7 mg anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Capecitabine Accord 150 mg film-coated tablets are light peach colored, oblong shaped, biconvex, 11.4 mm in length and 5.3 mm in width, debossed with ‘150’ on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer (see section 5.1). Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1). Capecitabine Accord 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 Accord 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 Accord should only be prescribed by a qualified physician experienced in the utilisation of antineoplastic medicinal 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 Accord of 1250 mg/m 2 and 1000 m Read the complete document