Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETORICOXIB
ORGANON MALAYSIA SDN. BHD.
ETORICOXIB
30tablet Tablets; 100tablet Tablets
Rovi Pharma Industrial Services S.A
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Copyright 2023 Organon group of companies. All rights reserved. ARCOXIA ® TABLET Etoricoxib (30 mg, 60 mg, 90 mg, 120 mg) WHAT IS IN THIS LEAFLET 1. What Arcoxia tablet is used for 2. How Arcoxia tablet works 3. Before you take Arcoxia tablet 4. How to take Arcoxia tablet 5. While you are taking Arcoxia tablet 6. Side effects 7. Storage and Disposal of Arcoxia tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ARCOXIA TABLET IS USED FOR Your doctor has prescribed Arcoxia tablet for: • treatment of osteoarthritis • treatment of rheumatoid arthritis • treatment of ankylosing spondylitis • chronic low back pain (30 mg and 60 mg only) • 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 ARCOXIA TABLET WORKS Arcoxia tablet is a member of a group of medicines called selective COX-2 inhibitors that are used to reduce pain and inflammation. Arcoxia tablet is not a narcotic. BEFORE YOU TAKE ARCOXIA TABLET _-_ _ _ _When you must not take it _ Do not take Arcoxia tablet if you: • are allergic to any of its ingredients • 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 Perskaitykite visą dokumentą
LPC-OG0663-T-022021-Malaysia LOCAL PRODUCT CIRCULAR TABLETS ARCOXIA® (ETORICOXIB) I. THERAPEUTIC CLASS ARCOXIA ® (etoricoxib) is a member of a class of arthritis/analgesia medications called Coxibs. ARCOXIA is a highly selective inhibitor of cyclooxygenase-2 (COX-2). II. COMPOSITION IIa. Active Ingredients Each tablet of ARCOXIA for oral administration contains either 30, 60, 90 or 120 mg of etoricoxib. IIb. Inactive Ingredients Each tablet contains calcium hydrogen phosphate (anhydrous), carnauba wax, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and glycerol triacetate. The 30 mg, 60 mg and 120 mg tablets also contain yellow ferric oxide and FD&C Blue #2 (indigo carmine lake). III. INDICATIONS ARCOXIA 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 • Chronic low back pain (30 mg and 60 mg only) • 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 (see PRECAUTIONS). IV. DOSAGE AND ADMINISTRATION ARCOXIA is administered orally. ARCOXIA may be taken with or without food. ARCOXIA should be administered for the shortest duration possible and the lowest effective daily dose should be used. Osteoarthritis The recommended dose is 30 mg or 60 mg once daily. Rheumatoid Arthritis The recommended dose is 60 mg or 90 mg once daily. The minimum effective daily dose is 60 mg once daily. In some patients, 90 mg once daily may provide increased therapeutic benefit. Ankylosing Spondylitis The recommended dose is 60 mg or 90 mg once daily. The minimum effective daily dose is 60 mg once daily. In some patients, 90 mg once daily may provide increased therapeutic benefit. Chronic low back pain _ _ The recommende Perskaitykite visą dokumentą