Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Etoricoxib
NV Organon
M01AH; M01AH05
Etoricoxib
90 milligram(s)
Film-coated tablet
Coxibs; etoricoxib
Marketed
2002-10-11
PACKAGE LEAFLET: INFORMATION FOR THE USER ARCOXIA ® 30 mg film-coated tablets ARCOXIA ® 60 mg film-coated tablets ARCOXIA ® 90 mg film-coated tablets ARCOXIA ® 120 mg film-coated tablets etoricoxib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ARCOXIA is and what it is used for 2. What you need to know before you take ARCOXIA 3. How to take ARCOXIA 4. Possible side effects 5. How to store ARCOXIA 6. Contents of the pack and other information 1. WHAT ARCOXIA IS AND WHAT IT IS USED FOR WHAT IS ARCOXIA? ARCOXIA contains the active substance etoricoxib. ARCOXIA is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). WHAT IS ARCOXIA USED FOR? ARCOXIA helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. ARCOXIA is also used for the short-term treatment of moderate pain after dental surgery in people 16 years of age and older. WHAT IS OSTEOARTHRITIS? Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability. WHAT IS RHEUMATOID ARTHRITIS? Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints Read the complete document
Health Products Regulatory Authority 28 October 2021 CRN00C8KV Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arcoxia 90 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg of etoricoxib. Excipients with known effect: 90 mg tablet: 4.0 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets (tablets). 90 mg tablets: White, apple-shaped, biconvex tablets debossed ‘202’ on one side and ‘ARCOXIA 90’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arcoxia is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. Arcoxia is indicated in adults and adolescents 16 years of age and older for the short-term treatment of moderate pain associated with dental surgery. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1). _Osteoarthritis_ The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. _Rheumatoid arthritis_ 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 e Read the complete document