Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CAPECITABINE
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
CAPECITABINE
60 Tablets
DR. REDDY'S LABORATORIES LIMITED
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CAPIIBINE 150 CAPIIBINE 500 _Capecitabine Film-Coated Tablets USP (150mg, 500mg)_ WHAT IS IN THIS LEAFLET 1. What Capiibine is used for 2. How Capiibine works 3. Before you use Capiibine 4. How to use Capiibine 5. While you are using it 6. Side effects 7. Storage and disposal of Capiibine 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT CAPIIBINE IS USED FOR Capiibine is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capiibine is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Capiibine may be used either alone or in combination with other medicines. HOW CAPIIBINE WORKS Capiibine belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capiibine 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 CAPIIBINE - _When you must not use it _ Do not take Capiibine 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 _ Capiibine is not indicated Baca dokumen lengkap
1 _For the use of an oncologist or a hospital or a laboratory only _ _ _ PRESCRIBING INFORMATION CAPIIBINE CAPECITABINE FILM-COATED TABLETS USP 150 MG AND CAPECITABINE FILM-COATED TABLETS USP 500 MG CAUTION: CYTOTOXIC AGENT COMPOSITION CAPIIBINE 150 Each film-coated tablet contains: Capecitabine USP 150 mg Colours: Titanium Dioxide, Red oxide of Iron and Yellow oxide of Iron CAPIIBINE 500 Each film-coated tablet contains: Capecitabine USP 500 mg Colours: Titanium Dioxide, Red oxide of Iron and Yellow oxide of Iron PRODUCT DESCRIPTION: _Capecitabine Film-Coated tablets USP 150 mg_ : Light peach colored, biconvex, oblong film coated tablets with “150” debossing on one side and ‘RDY’ on other side. _Capecitabine Film-Coated tablets USP 500 mg_ : Peach colored, biconvex, oblong tablets with “500” debossing on one side and ‘RDY’ on other side. CLINICAL INFORMATION THERAPEUTIC INDICATIONS: _Breast Cancer: _ CAPIIBINE 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. CAPIIBINE 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. CAPIIBINE 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: _ 2 CAPIIBINE is indicated for the treatment of patients with metastatic colorectal carcinoma. CAPIIBINE is indicated as adjuvant treatment of patients following surgery of Stage III (Duke’s Stage C) colon cancer. _Oesophagogastric Cancer: _ CAPIIBINE is indicated as first-line treatment of patients with advanced oesophagogastric cancer Baca dokumen lengkap