Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CAPECITABINE
DKSH MALAYSIA SDN. BHD.
CAPECITABINE
60 Tablets
Excella GmbH & Co.KG
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ XELODA ® TABLET _ _ _Capecitabine (150mg, 500mg) _ _ _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Xeloda is used for 2. How Xeloda works 3. Before you use Xeloda 4. How to use Xeloda 5. While you are using it 6. Side effects 7. Storage and disposal of Xeloda 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT XELODA IS USED FOR Xeloda is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Xeloda is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Xeloda may be used either alone or in combination with other medicines. HOW XELODA WORKS Xeloda belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Xeloda 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). BEFORE YOU USE XELODA - _When you must not use it _ Do not take Xeloda if: - You are allergic to capecitabine or any of the other ingredients of this medicine (listed at the end of this leaflet). 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- feeding, - if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia), - if you have severe liver or kidney problems, - if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD), - if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy. _Children and adolescents _ Xeloda is not indicated in children and adolescents. Do not give Xeloda to children and ado Baca dokumen lengkap
PACK INSERT FOR MALAYSIA XELODA ® CAPECITABINE 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Cytostatic agent ATC Code : L01BC06 1.2 TYPE OF DOSAGE FORM Tablets 150 mg and 500 mg. 1.3 ROUTE OF ADMINISTRATION Oral 1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_ : capecitabine. _150mg: _ Light peach, biconvex and oblong-shaped film-coated tablets containing 150 mg capecitabine. The tablets are engraved "XELODA" on one side and "150" on the other side. _500mg:_ Peach, biconvex, and oblong-shaped film-coated tablets containing 500 mg capecitabine. The tablets are engraved “XELODA” on one side and “500” on the other side. _ _ 2 . CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) _Breast Cancer: _ Xeloda 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. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of a taxane and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. Xeloda is indicated in combination with lapatinib ditosylate for the treatment of patients with advanced or metastatic breast cancer whose tumors over express HER2 and who have received prior therapy including an anthracycline, a taxane and trastuzumab. _Colon, Colorectal cancer: _ Xeloda is indicated for the treatment of patients with metastatic colorectal carcinoma. Xeloda is indicated as adjuvant treatment of patients following surgery of Stage III (Duke’s Stage C) colon cancer. _Oesophagogastric Cancer: _ Xeloda is indicated as first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen. 2.2 DOSAGE AND ADMINISTRATION _STANDARD DOSAGE _ Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. Xeloda tablets should not be cr Baca dokumen lengkap