Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
etoricoxib, Quantity: 60 mg
ORGANON PHARMA PTY LTD
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; Carnauba Wax; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; indigo carmine; triacetin; iron oxide yellow
Oral
30 Tablets, 5 Tablets, 10 Tablets
(S4) Prescription Only Medicine
Arcoxia is indicated for: - Symptomatic treatment of the signs and symptoms of osteoarthritis (OA). - Treatment of acute gouty arthritis. - Treatment of acute pain, including that related to primary dysmenorrhea 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.
Visual Identification: Dark green, apple-shaped, biconvex film-coated tablet debossed "200" on one side and "ARCOXIA 60" on the other side; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2002-10-11
ARCOXIA ® _Etoricoxib (pronounced ee-TOR-ee-cox-ib)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ARCOXIA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ARCOXIA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ARCOXIA IS USED FOR ARCOXIA is used for the following: • to treat the symptoms of osteoarthritis • to treat gout attacks • to relieve short term pain, including cramp-like pain or discomfort before or during a menstrual period, and pain associated with minor dental procedures. OSTEOARTHRITIS Osteoarthritis is a joint disease. It results from the gradual breakdown of the cartilage that covers the joints and cushions the ends of bones. Symptoms of osteoarthritis include pain, tenderness, stiffness of one or more joints, and physical disability. The hips and knees are the most commonly affected joints, but other joints, such as those of the hands and spine, may also be affected. Osteoarthritis is more common in women than in men. Many factors can lead to the development of osteoarthritis, including obesity and joint injury (e.g. from sport). GOUT Gout is a disease that causes attacks of arthritis, usually in a single joint. The affected joint is red, swollen, painful and extremely tender. A gout attack usually lasts a few days and it may recur. For more information about osteoarthritis or gout, contact the Arthritis Foundation in the capital city of your state. _HOW ARCOXIA WORKS_ ARCOXIA belongs to a group of medicines called Coxibs. It works in a similar way to traditional anti- inflammatory medicines, known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), by blocking the production of substances that cause pain and inflammat Read the complete document
Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION ARCOXIA ® (ETORICOXIB) 1 NAME OF THE MEDICINE etoricoxib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Etoricoxib is a white to off-white powder. Etoricoxib is freely soluble in methanol, tetrahydrofuran, dimethyl sulfoxide, methyl ethyl ketone, dimethyl formamide, and chloroform. Etoricoxib is soluble in isopropyl acetate, ethanol and toluene, sparingly soluble in 2-propanol, and practically insoluble in water. Each tablet of ARCOXIA for oral administration contains either 30, 60, 90 or 120 mg of etoricoxib. Excipients with known effect: lactose monohydrate For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM ARCOXIA (etoricoxib) 30 mg is a blue-green, apple-shaped, biconvex film coated tablet debossed "101" on one side and "ACX 30" on the other side. ARCOXIA (etoricoxib) 60 mg is a dark green, apple-shaped, biconvex film coated tablet engraved "200" on one side and "ARCOXIA 60" on the other side. ARCOXIA (etoricoxib) 90 mg is a white, apple-shaped, biconvex film coated tablet debossed "202" on one side and "ARCOXIA 90" on the other side. ARCOXIA (etoricoxib) 120 mg is a pale green, apple-shaped, biconvex film coated tablet engraved "204" on one side and "ARCOXIA 120" on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ARCOXIA is indicated for: • Symptomatic treatment of the signs and symptoms of osteoarthritis (OA) • 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 DOSE AND METHOD OF ADMINISTRATION ARCOXIA is administered orally. ARCOXIA may be taken with or without food. As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. Patients on long Page 2 of 29 term treatment sho Read the complete document