देश: आर्मेनिया
भाषा: अंग्रेज़ी
स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
capecitabine
Accord Healthcare Polska Sp. z o.o.
L01BC06
capecitabine
500mg
tablets film-coated
(120/1x120/), in blister
Prescription
Registered
2021-06-23
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. (see section 4). 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 over reaction to this medicine, • पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Capecitabine Accord 150 mg film-coated tablets Each film-coated tablet contains 150 mg of capecitabine. Capecitabine Accord 300 mg film-coated tablets Each film-coated tablet contains 300 mg of capecitabine. Capecitabine Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg of capecitabine. Excipient with known effect _ _ _Capecitabine Accord 150 mg film-coated tablets _ _ _ Each film-coated tablet contains 7 mg anhydrous lactose. _Capecitabine Accord 300 mg film-coated tablets _ Each film-coated tablet contains 15 mg anhydrous lactose _Capecitabine Accord 500 mg film-coated tablets _ Each film-coated tablet contains 25 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 The 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. Capecitabine Accord 300 mg film-coated tablets The film-coated tablets are white to off white, oblong shaped, biconvex, 14.6 mm in length and 6.7 mm in width, debossed with ‘300’ on one side and plain on other side. Capecitabine Accord 500 mg film-coated tablets The film-coated tablets are peach colored, oblong shaped, biconvex, 15.9 mm in length and 8.4 mm in width, debossed with ‘500’ on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Capecitabine Accord is indicated for the treatment of: 3 -for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). - metastatic colorectal cancer (see section 5.1). - first-line treatment of advanced gastric cancer in combination with a platinum bas पूरा दस्तावेज़ पढ़ें