Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CAPECITABINE
ACCORD HEALTHCARE SDN.BHD.
CAPECITABINE
120tablet Tablets; 120tablet Tablets
INTAS PHARMACEUTICALS LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ INTACAPE 500MG TABLETS _Capecitabine Tablets (500 mg_ _)_ WHAT IS IN THIS LEAFLET? 1. What INTACAPE is used for 2. How INTACAPE works 3. Before you use INTACAPE 4. How to take INTACAPE 5. While you are using INTACAPE 6. Side effects 7. Storage and disposal of INTACAPE 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT INTACAPE IS USED FOR INTACAPE is a prescription medicine used to treat people with: □ breast cancer that has spread to other parts of the body (metastatic) together with another medicine called docetaxel after treatment with certain other anticancer medicines have not worked. □ breast cancer that has spread to other parts of the body and has not improved after treatment with taxanes and anthracyclines, or who cannot receive any more treatment with certain anti-cancer medicines. □ After surgery of stage III cancer of the colon (Dukes’ C stage. □ cancer of the colon or rectum (colorectal) that has spread to other parts of the body (metastatic). □ As 1 st line treatment for patients with cancer of the foodpipe (esophagus) or stomach in combination with drugs belonging to the class platinums. It is not known if INTACAPE is safe and effective in children. HOW INTACAPE WORKS INTACAPE belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. INTACAPE 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 INTACAPE When you must not take it Do not take INTACAPE if you: □ have severe kidney problems. □ are allergic to capecitabine, 5- fluorouracil, or any of the ingredients in INTACAPE. See the end of this leaflet for a complete list of ingredients in INTACAPE. □ Talk to your doctor before taking INTACAPE if you are not sure if you have any of the conditions listed above. Before you start to Lestu allt skjalið
PACKAGE INSERT INTACAPE 500 mg Tablets (Capecitabine Tablets USP 500 mg) A) NAME AND STRENGTH OF ACTIVE SUBSTANCE Each film coated tablet contains: Capecitabine USP 500 mg B) PRODUCT DESCRIPTION Peach coloured, oblong shaped, biconvex, film coated tablets, debossed with ‘500’ on one side and plain on other side. C) PHARMACODYNAMICS/ PHARMACOKINETICS _Pharmacodynamic properties _ Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU). Capecitabine is activated via several enzymatic steps. The enzyme involved in the final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues, albeit usually at lower levels. In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of thymidine phosphorylase by docetaxel. There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA). The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis. Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell. The effects of DNA and RNA deprivation are most marked on those cells which proliferate more rapidly and which metabolise 5-FU at a more rapid rate. _Pharmacokinetic properties _ The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m2/day. The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'- deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were similar. The AUC of 5- FU was 30%-35% higher on day 14. Capecitabine dose reduction decreases systemic exposure to 5-FU more than dose-proportionally, due to non-linear pharmacokinetics for the Lestu allt skjalið