Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
ETORICOXIB
Actavis Group PTC ehf
M01AH05
ETORICOXIB
120 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Coxibs
Authorised
2017-03-24
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. ETORICOXIB 30MG, 60MG, 90MG & 120MG 28 TABLETS PIL - UK Black BBBA0322 S.Anson 12.12.16 13.12.16 S.Anson 190 x 380 9pts Actavis Malta Zejtun 12.12.16 2 ETORICOXIB 30 MG, 60 MG, 90 MG AND 120 MG FILM-COATED TABLETS etoricoxib _Continued top of next column_ _Continued over page_ PACKAGE LEAFLET: INFORMATION FOR THE USER 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 WHAT IS ETORICOXIB? • Etoricoxib contains the active substance etoricoxib. Etoricoxib 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 ETORICOXIB USED FOR? • Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarth Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoricoxib 120 milligram Film Coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120 mg of etoricoxib. Excipients with known effect: 120 mg tablet: 2.88 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). White to off white, 13.5 x 6.75 mm oval film-coated tablet debossed '752' on one side and 'A' on the other side. 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 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 efficacy. Once the patient is clinically stabilised, down-titration to a 60 Citiți documentul complet