País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETORICOXIB
NOVUGEN PHARMA SDN. BHD.
ETORICOXIB
1x10 Tablets; 3x10 Tablets; 6x10 Tablets; 10x10 Tablets; 50x10 Tablets; 100x10 Tablets; 1x15 Tablets; 2x15 Tablets; 4x15 Tablets; 6x15 Tablets; 8x15 Tablets; 12x15 Tablets
NOVUGEN PHARMA SDN. BHD.
1 ELIPIX FILM COATED TABLETS Etoricoxib 60mg, 90mg, 120mg _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Elipix tablet is used for 2. How Elipix tablet works 3. Before you use Elipix tablet 4. How to use Elipix tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Elipix tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ELIPIX TABLET IS USED FOR Your doctor has prescribed Elipix 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 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 functions 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 ELIPIX TABLET WORKS Elipix tablet is a member of a group of medicines called selective COX-2 inhibitors that are used to reduce pain and inflammation. Elipix tablet is not a narcotic. BEFORE YOU USE ELIPIX TABLET - _ When you must not use it _ Do not take Elipix tablet it you: • are allergic to etoricoxib or any of other ingredients of this medicine. • have had heart failure, a heart attack, bypass surgery, chest pain, narrow or blocked arteries of the extremities, a stroke or mini stroke • have high blood pressure that has not been controlled by treatment • are or could be pregnant - _Before you start to use it _ Tell your do Leer el documento completo
ELIPIX 60MG ELIPIX 90MG ELIPIX 120MG FILM COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Elipix 60mg Film Coated Tablets Elipix 90mg Film Coated Tablets Elipix 120mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ELIPIX 60MG FILM COATED TABLETS: Each tablet contains 60mg of Etoricoxib. ELIPIX 90MG FILM COATED TABLETS: Each tablet contains 90mg of Etoricoxib. ELIPIX 120MG FILM COATED TABLETS: Each tablet contains 120mg of Etoricoxib. For the full list of excipients, see section List of excipients. 3. PHARMACEUTICAL FORM Film Coated Tablets. ELIPIX 60MG: Blue-green, round shaped film-coated tablet debossed with ‘N’ on one side and ‘15’ on the other side. ELIPIX 90MG: White, round shaped film-coated tablet debossed with ‘N’ on one side and ‘14’ on the other side. ELIPIX 120MG: Pale green, round shaped film-coated tablet debossed with ‘N’ on one side and ‘13’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoricoxib is indicated for: • Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) • Treatment of ankylosing spondylitis (AS) • Treatment of acute gouty arthritis • Treatment of acute pain, including that related to primary dysmenorrhoea and minor dental procedures. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Etoricoxib is administered orally and may be taken with or without food. Etoricoxib should be administered for the shortest duration possible and the lowest effective daily dose should be used. _ _ _Osteoarthritis (OA) _ The recommended dose is 30 mg or 60 mg once daily. _ _ _Rheumatoid Arthritis (RA) _ The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropri Leer el documento completo