Country: Malta
Language: English
Source: Medicines Authority
ETORICOXIB
Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic
M01AH05
ETORICOXIB 60 mg
FILM-COATED TABLET
ETORICOXIB 60 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2016-06-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Etoricoxib Zentiva 30 mg film-coated tablets Etoricoxib Zentiva 60 mg film-coated tablets Etoricoxib Zentiva 90 mg film-coated tablets Etoricoxib Zentiva 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 Zentiva is and what it is used for 2. What you need to know before you take Etoricoxib Zentiva 3. How to take Etoricoxib Zentiva 4. Possible side effects 5. How to store Etoricoxib Zentiva 6. Contents of the pack and other information 1. WHAT ETORICOXIB ZENTIVA IS AND WHAT IT IS USED FOR Etoricoxib Zentiva contains the active substance etoricoxib. Etoricoxib Zentiva 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 Zentiva 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 Zentiva 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 c Read the complete document
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Etoricoxib Zentiva 30 mg film-coated tablets Etoricoxib Zentiva 60 mg film-coated tablets Etoricoxib Zentiva 90 mg film-coated tablets Etoricoxib Zentiva 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Etoricoxib Zentiva 30 mg film-coated tablets: White to off white round biconvex film-coated tablets, approx. 6 mm in diameter. Etoricoxib Zentiva 60 mg film-coated tablets: Light brown round biconvex film-coated tablets, approx. 8 mm in diameter. Etoricoxib Zentiva 90 mg film-coated tablets: Light yellow round biconvex film-coated tablets, approx. 9 mm in diameter. Etoricoxib Zentiva 120 mg film-coated tablets: Light pink round biconvex film-coated tablets, approx. 10 mm in diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoricoxib Zentiva 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 Zentiva 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). Page 2 of 19 _Osteoarthritis _ The recommended dos Read the complete document