Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
ETORICOXIB
Merck Sharp & Dohme Ireland (Human Health) Limited
ETORICOXIB
30 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2014-08-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ACOXXEL 30 mg film-coated tablets ACOXXEL 60 mg film-coated tablets ACOXXEL 90 mg film-coated tablets ACOXXEL 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. WHAT IS IN THIS LEAFLET 1. What ACOXXEL is and what it is used for 2. What you need to know before you take ACOXXEL 3. How to take ACOXXEL 4. Possible side effects 5. How to store ACOXXEL 6. Contents of the pack and other information 1. WHAT ACOXXEL IS AND WHAT IT IS USED FOR • ACOXXEL 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). • ACOXXEL helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. • ACOXXEL is also used for the short term treatment of moderate pain after dental surgery. 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 i Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acoxxel 30 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30mg of etoricoxib. Excipients with known effect: 30 mg: lactose 1.3 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). 30 mg Tablets: Blue-green, apple-shaped biconvex tablets marked ‘ACX 30’ on one side and ‘101’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. 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 90 mg once daily. _Ankylosing spondylitis_ The recommended dose is 90 mg once daily. For acute pain conditions, etoricoxib should be used only Olvassa el a teljes dokumentumot