Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Etoricoxib
Bristol Laboratories Limited
M01AH; M01AH05
Etoricoxib
60 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Coxibs; etoricoxib
Not marketed
2017-06-16
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 this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE 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 osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. SAME SIZE ARTWORK 520 mm x 150 mm • 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 is a long term inflammatory disease of the joints. It cau Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoricoxib 60 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg of etoricoxib. Excipient with known effect: Also contains 1.68 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Green, round, biconvex, film-coated tablets debossed with ‘444’ on one side and ‘L’ on other side. The tablet diameter is 8.00 mm. 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-titratio Baca dokumen lengkapnya