Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ETORICOXIB
B & S Healthcare
M01AH05
ETORICOXIB
60 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Coxibs
Authorised
2012-05-04
PACKAGE LEAFLET: INFORMATION FOR THE USER ARCOXIA ® 30MG FILM-COATED TABLETS ARCOXIA ® 60MG FILM-COATED TABLETS ARCOXIA ® 90MG FILM-COATED TABLETS ARCOXIA ® 120MG 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. The name of your medicine is ARCOXIA 30mg film-coated tablets or ARCOXIA 60mg film-coated tablets or ARCOXIA 90mg film-coated tablets or ARCOXIA 120mg film-coated tablets but, will be referred to as ARCOXIA throughout this leaflet. WHAT IS IN THIS LEAFLET 1. What ARCOXIA is and what it is used for 2. What you need to know before you take ARCOXIA 3. How to take ARCOXIA 4. Possible side effects 5. How to store ARCOXIA 6. Contents of the pack and other information 1. WHAT ARCOXIA IS AND WHAT IT IS USED FOR WHAT IS ARCOXIA? ARCOXIA contains the active substance etoricoxib ARCOXIA 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 ARCOXIA USED FOR? ARCOXIA 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 read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arcoxia 60mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg of etoricoxib. Excipient: lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet _Product imported from Portugal_: Dark green, apple-shaped, biconvex tablets debossed ‘200’ on one side and ‘ARCOXIA 60' on the other side. 4 CLINICAL PARTICULARS As per PA1286/007/002 5 PHARMACOLOGICAL PROPERTIES As per PA1286/007/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Core: Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Tablet coating: Carnauba wax Lactose monohydrate Hypromellose Titanium dioxide (E171) Triacetin Indigo carmine lake (E132) and Yellow ferric oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/11/2015_ _CRN 2168560_ _page number: 1_ 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminum/aluminium blisters in packs containing 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER B & S Healthcare Unit 4, Bradfield Road Ruislip Middlesex HA4 0NU United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1328/159/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 4 th May 2012 10 DATE read_full_document