국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
ETORICOXIB
McDermott Laboratories Ltd t/a Gerard Laboratories
M01AH05
ETORICOXIB
120 Milligram
Film Coated Tablet
oral use
2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98, 100 tablets
Product subject to prescription which may be renewed (B)
Mylan Hungary Kft, Mylan Hungary Kft, Mylan B.V,, McDermott Laboratories Limited trading as Gerard Laboratories,
Antiinflammatory and antirheumatic products, non-steroids, coxibs
Coxibs
Etoricoxib 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. Etoricoxib 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 cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks
Authorised
2015-09-11
26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ETORICOXIB 30 MG FILM-COATED TABLETS ETORICOXIB 60 MG FILM-COATED TABLETS ETORICOXIB 90 MG FILM-COATED TABLETS ETORICOXIB 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 Etoricoxib is and what it is used for 2. What you need to know before you take Etoricoxib 3. How to take Etoricoxib 4. Possible side effects 5. How to store Etoricoxib 6. Contents of the pack and other information 1. WHAT ETORICOXIB IS AND WHAT IT IS USED FOR Etoricoxib is one of a group of medicines called selective cyclooxygenase-2 (COX-2) inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). - Etoricoxib 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. - Etoricoxib 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 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoricoxib 120mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120 mg of etoricoxib. Excipients with known effect: Each film-coated tablet contains 3.19 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pale green, film-coated, round, biconvex, bevelled edge tablet debossed with ‘M’ on one side and ‘EC4’ on the other side, approximately 10 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoricoxib 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. Etoricoxib 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 cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 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 전체 문서 읽기