Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Etoricoxib
PCO Manufacturing Ltd.
M01AH05
Etoricoxib
60 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
etoricoxib
Authorised
2006-04-07
_ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER ARCOXIA ® 30 MG FILM-COATED TABLETS ARCOXIA ® 60 MG FILM-COATED TABLETS ARCOXIA ® 90 MG FILM-COATED TABLETS ARCOXIA ® 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 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 spondylitis and gout. Arcoxia 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 causes pain, stiffness, swelling and increasing loss of movemen Citiți documentul complet
Health Products Regulatory Authority 08 June 2022 CRN00CZ14 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arcoxia 60 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60mg of etoricoxib. Excipient with known effect: lactose (as monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets (tablets). _Product imported from France, Spain, Greece and Romania:_ Dark-green, apple-shaped, biconvex film-coated tablets marked ‘Arcoxia 60’ on one side and '200' on the other side. _Product imported from Italy:_ Dark-green, apple-shaped, biconvex, film-coated tablets marked ‘ARCOXIA 60’ on one side and ‘200’ on the other. or Dark-green, apple-shaped, biconvex, film-coated tablets which are blank on one side and marked with ‘200’ on the other. 4 CLINICAL PARTICULARS As per PA0964/009/002 5 PHARMACOLOGICAL PROPERTIES As per PA0964/009/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate Microcrystalline cellulose. Carnauba wax Lactose monohydrate Hypromellose Titanium dioxide (E171) Triacetin Indigo carmine lake (E132) Yellow ferric oxide (E172). 6.2 INCOMPATIBILITIES Health Products Regulatory Authority 08 June 2022 CRN00CZ14 Page 2 of 2 Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container 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. Do not store above 25 o C. 6.5 NATURE AND CONTENTS OF CONTAINER Blisters in packs containing 28 or 30 tablets. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with the local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbo Citiți documentul complet