Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
capecitabine
medac Gesellschaft für klinische Spezialpräparate mbH
L01BC06
capecitabine
Antineoplastic agents
Colorectal Neoplasms
Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer.Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine Medac 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 Medac 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: 13
Authorised
2012-11-19
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CAPECITABINE MEDAC 150 MG FILM - COATED TABLETS CAPECITABINE MEDAC 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 medac is and what it is used for 2. What you need to know before you take Capecitabine medac 3. How to take Capecitabine medac 4. Possible side effects 5. How to store Capecitabine medac 6. Contents of the pack and other information 1. WHAT CAPECITABINE MEDAC IS AND WHAT IT IS USED FOR Capecitabine medac belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine medac 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 medac is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine medac is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Capecitabine medac may be used either alone or in combination with other medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE MEDAC DO NOT TAKE CAPECITABINE MEDAC • 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 sev Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Capecitabine medac 150 mg film-coated tablets Capecitabine medac 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine. Capecitabine medac 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine. Excipients with known effect _Capecitabine medac 150 mg film-coated tablets _ Each film-coated tablet contains 7 mg anhydrous lactose. _Capecitabine medac 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 (tablet). Capecitabine medac 150 mg film-coated tablets The film-coated tablets are light peach coloured, oblong shaped, biconvex tablets of 11.4 mm in length and 5.3 mm in width, debossed with ‘150’ on one side and plain on other side. Capecitabine medac 500 mg film-coated tablets The film-coated tablets are peach coloured, oblong shaped, biconvex tablets of 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 medac is indicated: • for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). • for the treatment of metastatic colorectal cancer (see section 5.1). • for 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. 3 • 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 a Прочетете целия документ