Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETORICOXIB
MEDISPEC (M) SDN.BHD
ETORICOXIB
3 x 10 Tablets
Biolab Co., Ltd
BIOCOXIB 90MG/120MG FILM COATED TABLET Etoricoxib (90mg, 120mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _BIOCOXIB_ _ _ is used for 2. How _BIOCOXIB_ _ _ works 3. Before you use _BIOCOXIB_ 4. How to use _BIOCOXIB_ _ _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _BIOCOXIB_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _BIOCOXIB_ IS USED FOR Your doctor has prescribed BIOCOXIB Tablet for: • treatment of osteoarthritis • treatment of rheumatoid arthritis • treatment of ankylosing spondylitis • treatment of acute pain after minor dental procedures • treatment of menstrual pain • treatment of gout attacks Osteoarthritis is a joint disease. It results from the gradual breakdown of the cartilage that cushions the ends of the bones, resulting in pain, inflammation, tenderness, stiffness, and physical disability. Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling and loss of function in the joints and inflammation in other body organs. Ankylosing spondylitis is an inflammatory disease of the spine and large joints. Gout is a disorder characterized by sudden, recurring attacks of pain and inflammation in one or more joints. You may obtain further information from your doctor or pharmacist, who have more detailed information. HOW _BIOCOXIB_ _ _ WORKS Etoricoxib is a non-steroidal anti- inflammatory drug (NSAIDs) which is highly selective cyclo-oxygenase-2 (COX-2) inhibitor with anti- inflammatory and analgesic properties. BEFORE YOU USE _BIOCOXIB_ _ _ - _When you must not use it _ Do not use _BIOCOXIB_ _:_ • If you are allergic to Etoricoxib or any of the others ingredients • If you are allergic to NSAIDs, including aspirin and COX-2 inhibitors • If you have stomach ulcer • If you have serious liver disease • If you have serious kidney disease • If you are under 16 years’ old • If you have inflammatory bowel disease • If you have high blood pressure Aqra d-dokument sħiħ
P. 1/11 LEAFLET BIOCOXIB 90 MG AND 120 MG FILM COATED TABLET COMPOSITION : Each tablet contains : Etoricoxib 90 mg, 120 mg PRODUCT DESCRIPTION : BIOCOXIB 90 MG Film Coated Tablet : Asymmetric hexagonal with rounded corners, white film-coated tablets, impressed “BC” on one side and “90” on the other. BIOCOXIB 120 MG Film Coated Tablet: Asymmetric hexagonal with rounded corners, light green film-coated tablets, impressed “BC” on one side and “120” on the other. PHARMACOLOGY : _Pharmacodynamics _ Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. It did not inhibit gastric prostaglandin synthesis and had no effect on platelet function. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established. _ _ _Pharmacokinetics _ Absorption Etoricoxib is well absorbed from the gastrointestinal tract after oral doses. The absolute bioavailability is approximately 100%. Peak plasma concentrations are reached in about 1 hour in fasted adults. The pharmacokinetics of etoricoxib are linear across the clinical dose range. Dosing with food (a high-fat meal) had no effect on the extent of absorption of etoricoxib after administration. Food delays absorption, resulting peak plasma concentrations by about 2 hour Aqra d-dokument sħiħ