Страна: Мальта
мова: англійська
Джерело: Medicines Authority
ETORICOXIB
Chanelle Medical
M01AH05
ETORICOXIB
FILM-COATED TABLET
ETORICOXIB 30 milligram(s)
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2016-03-04
Page 1 of 7 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 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 with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. Etoricoxib is also used for the short term treatment of moderate pain after dental surgery. Etoricoxib is indicated in adults and adolescents over 16 years of age. 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 it affects. It may also cause inflammation Прочитайте повний документ
Page 1 of 19 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Etoricoxib 30 mg Film-coated Tablets Etoricoxib 60 mg Film-coated Tablets Etoricoxib 90 mg Film-coated Tablets Etoricoxib 120 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Etoricoxib 30 mg: Each film-coated tablet contains 30 mg of etoricoxib. Excipients with known effect: 2.52 mg lactose (as lactose monohydrate). Etoricoxib 60 mg: Each film-coated tablet contains 60 mg of etoricoxib. Excipients with known effect: 5.04 mg lactose (as lactose monohydrate). Etoricoxib 90 mg: Each film-coated tablet contains 90 mg of etoricoxib. Excipients with known effect: 7.56 mg lactose (as lactose monohydrate). Etoricoxib 120 mg: Each film-coated tablet contains 120 mg of etoricoxib. Excipients with known effect: 10.08 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Etoricoxib 30 mg: Blue-green, apple-shaped, biconvex film coated tablets engraved ‘30’ on one face and other face plain. Etoricoxib 60 mg: Dark-green, apple-shaped, biconvex film coated tablets engraved ‘60’ on one face and other face plain. Etoricoxib 90 mg: White, apple-shaped, biconvex film coated tablets engraved ‘90’ on one face and other face plain. Etoricoxib 120 mg: Pale-green, apple-shaped, biconvex film coated tablets engraved ‘120’ on one face and other face plain. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Page 2 of 19 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). Etoricoxib is indicated in adults and adolescents over 16 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology As Прочитайте повний документ