Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Etoricoxib 30mg
Organon (New Zealand) Limited
Etoricoxib 30 mg
30 mg
Film coated tablet
Active: Etoricoxib 30mg Excipient: Calcium hydrogen phosphate Carnauba wax Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry green 39K11526 Purified water
Blister pack, Sample Pack - PVC/Al, 10 tablets
Prescription
Prescription
F.I.S. Fabbrica Italiana Sintetici SpA
Arcoxia is indicated for: · Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) · The management of ankylosing spondylitis (AS) · Treatment of acute gouty arthritis · Relief of acute pain, including pain related to minor dental procedures · Relief of chronic musculoskeletal pain The decision to prescribe a selective COX-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapy i.e.paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and · after assessment of the individual patient's overall risk factors for developing severe adverse events e.g. history of cardiovascular, renal or gastrointestinal disease.
Package - Contents - Shelf Life: Blister pack, Sample Pack - PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C
2006-07-14
ARCOXIA ® TABLETS 1 New Zealand Consumer Medicine Information ARCOXIA ® _Etoricoxib_ 30 mg, 60 mg, 90 mg & 120 mg tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using ARCOXIA. 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: • acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) • management of ankylosing spondylitis • relief of chronic musculoskeletal pain • relief of acute pain, including pain associated with minor dental procedures • to treat acute gouty arthritis Your doctor will prescribe ARCOXIA for you only after you have used other medicines, i.e paracetamol for your condition and it has not been suitable for you. Your doctor will want to discuss your treatment with ARCOXIA from time to time. It is important that you use the lowest dose that controls your pain and you should not take ARCOXIA for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses. 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 develop Read the complete document
NEW ZEALAND DATA SHEET Page 1 of 29 1 ARCOXIA® (etoricoxib) film coated tablets ARCOXIA® 30mg film coated tablets ARCOXIA® 60mg film coated tablets ARCOXIA® 90mg film coated tablets ARCOXIA® 120mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib. Excipients with known effect: 30 mg tablet: 1.4 mg lactose (as monohydrate) 60 mg tablet: 2.8 mg lactose (as monohydrate) 90 mg tablet: 4.2 mg lactose (as monohydrate) 120 mg tablet: 5.6 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 30mg tablet: A blue green apple shaped biconvex film coated tablet debossed 101 on one side and ACX 30 on the other. Dimensions are 5.69 mm x 5.54 mm. 60mg tablet: A dark green apple shaped biconvex film coated tablet debossed 200 on one side and ARCOXIA 60 on the other. Dimensions are 7.16 mm x 6.99 mm. 90mg tablet: A white apple shaped biconvex film coated tablet debossed 202 on one side and ARCOXIA 90 on the other. Dimensions are 8.20 mm x 8.00 mm. 120mg tablet: A pale green apple shaped biconvex film coated tablet debossed 204 on one side and ARCOXIA 120 on the other. Dimensions are 9.03 mm x 8.80 mm. Do not halve tablet. Studies on divided tablets have not been performed. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications ARCOXIA is indicated for: • Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) • The management of ankylosing spondylitis (AS) • Treatment of acute gouty arthritis • Relief of acute pain, including pain related to minor dental procedures • Relief of chronic musculoskeletal pain The decision to prescribe a selective COX-2 inhibitor should only be made: NEW ZEALAND DATA SHEET Page 2 of 29 • if non-pharmacological interventions and simple analgesic therapy i.e paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and • after assessment of Read the complete document