Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
capecitabine
Krka, d.d., Novo mesto
L01BC06
capecitabine
Antineoplastic agents
Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Ecansya is indicated for the treatment of metastatic colorectal cancer.Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Ecansya 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. Ecansya 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
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ECANSYA 150 MG FILM-COATED TABLETS ECANSYA 300 MG FILM-COATED TABLETS ECANSYA 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 Ecansya is and what it is used for 2. What you need to know before you take Ecansya 3. How to take Ecansya 4. Possible side effects 5. How to store Ecansya 6. Contents of the pack and other information 1. WHAT ECANSYA IS AND WHAT IT IS USED FOR Ecansya belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Ecansya 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). Ecansya is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Ecansya is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Ecansya may be used either alone or in combination with other medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ECANSYA DO NOT TAKE ECANSYA - 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 fluoropyrimidine therapy (a group of anticancer medicines, such as fluorouracil), - if you are pregnant or breast-feedi Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ecansya 150 mg film-coated tablets Ecansya 300 mg film-coated tablets Ecansya 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ecansya 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine. _Excipient with known effect_ Each film-coated tablet contains 7 mg lactose. Ecansya 300 mg film-coated tablets Each film-coated tablet contains 300 mg capecitabine. _Excipient with known effect_ Each film-coated tablet contains 15 mg lactose. Ecansya 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine. _Excipient with known effect_ Each film-coated tablet contains 25 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Ecansya 150 mg film-coated tablets The tablets are light peach colored, 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. Ecansya 300 mg film-coated tablets The tablets are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with "300" on one side and plain on other side. Ecansya 500 mg film-coated tablets The tablets are peach colored, 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 Ecansya 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). 3 - 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 Прочетете целия документ