Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
capecitabine
Teva Pharma B.V.
L01BC06
capecitabine
Antineoplastic agents
Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer.Capecitabine Teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based regimen.Capecitabine Teva in combination with docetaxel 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 Teva 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.
Revision: 15
Authorised
2012-04-20
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ CAPECITABINE TEVA 150 MG FILM-COATED TABLETS CAPECITABINE TEVA 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 Teva is and what it is used for 2. What you need to know before you take Capecitabine Teva 3. How to take Capecitabine Teva 4. Possible side effects 5. How to store Capecitabine Teva 6. Contents of the pack and other information 1. WHAT CAPECITABINE TEVA IS AND WHAT IT IS USED FOR Capecitabine Teva belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Teva 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 Teva is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine Teva is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Capecitabine Teva may be used either alone or in combination with other medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE TEVA _ _ DO NOT TAKE CAPECITABINE TEVA_ _ - 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, - if you previously have had severe reactions to fluor Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine. Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine. Excipient with known effect _Capecitabine Teva 150 mg film-coated tablets _ Each film-coated tablet contains 15.6 mg lactose. _Capecitabine Teva 500 mg film-coated tablets _ Each film-coated tablet contains 52.0 mg lactose. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Film-coated tablet Capecitabine Teva 150 mg film-coated tablets The film-coated tablets are oval biconvex light peach, 11.5 mm x 5.4 mm with inscription “C” on one side and “150”on the other side. Capecitabine Teva 500 mg film-coated tablets The film-coated tablets are oval biconvex light peach, 16.0 mm x 8.5 mm with inscription “C” on one side and “500”on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Capecitabine Teva is indicated for the treatment of: - 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-based regimen (see section 5.1). - in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. - 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. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Capecitabine Teva should only be prescribed by Citiți documentul complet