Negara: Malta
Bahasa: Inggris
Sumber: Malta Medicines Authority
Pharmacare Premium Limited HHF 003 Halfar Industrial Estate Birzebbugia BBG 3000, Malta
L01BC06
CAPECITABINE 500 mg
FILM-COATED TABLET
CAPECITABINE 500 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2023-08-01
CAPECITABINE PHARMACARE 150MG & 500MG FILM-COATED TABLETS Capecitabine 150mg and 500mg 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 Pharmacare is and what it is used for 2. What you need to know before you take Capecitabine Pharmacare 3. How to take Capecitabine Pharmacare 4. Possible side effects 5. How to store Capecitabine Pharmacare 6. Contents of the pack and other information 1. WHAT CAPECITABINE PHARMACARE IS AND WHAT IT IS USED FOR Capecitabine Pharmacare belongs to a group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Pharmacare 150 mg contains 150 mg of Capecitabine and Capecitabine Pharmacare 500 mg contains 500 mg of capecitabine, which is not a cytostatic agent in itself. Only after having been absorbed by the body is it changed into an active anti-cancer medicine (more in tumor tissue than in normal tissue). Capecitabine Pharmacare is prescribed by doctors for the treatment of colon, rectal, gastric or breast cancers. Capecitabine Pharmacare may also be prescribed by doctors to prevent recurrence of colon cancer after complete surgical removal of the tumor. Capecitabine Pharmacare may be used either alone or in combination with other medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE PHARMACARE DO NOT TAKE CAPECITABINE PHARMACARE: - If you are allergic to capecitabine or any other ingredient of this medicine (indicated in section 6). You must inform your doctor if you know that you have an allergy or ov Baca dokumen lengkapnya
Page 1 of 29 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Capecitabine Pharmacare 500 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg capecitabine. Excipients with known effect Each film-coated tablet contains 25.470 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. (Pale) peach coloured, capsule shaped, biconvex, film-coated tablets, debossed with “500” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Capecitabine Pharmacare is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). Capecitabine Pharmacare is indicated for the treatment of metastatic colorectal cancer (see section 5.1). Capecitabine Pharmacare is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1). Capecitabine Pharmacare,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 Pharmacare 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 Pharmacare should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic 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 Pharmacare of 1,25 Baca dokumen lengkapnya