Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Etoricoxib
PCO Manufacturing Ltd.
M01AH05
Etoricoxib
90 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 Belgenin tamamını okuyun
Health Products Regulatory Authority 08 June 2022 CRN00CZ14 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arcoxia 90 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg of etoricoxib. Excipient with known effect: lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Spain, Greece and Romania:_ White, apple-shaped, biconvex film-coated tablets marked ‘Arcoxia 90’ on one side and '202' on the other. _Product imported from Italy:_ White apple-shaped, biconvex, film-coated tablets which are marked with ‘ARCOXIA 90’ on one side and ‘202’ on the other. Or White apple-shaped, biconvex, film-coated tablets which are blank on one side and marked with ‘202’ on the other. 4 CLINICAL PARTICULARS As per PA0964/009/003 5 PHARMACOLOGICAL PROPERTIES As per PA0964/009/003 5.1 PHARMACODYNAMIC PROPERTIES M01AH M01AH05 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 Health Products Regulatory Authority 08 June 2022 CRN00CZ14 Page 2 of 2 6.2 INCOMPATIBILITIES 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, Ashbourne Busine Belgenin tamamını okuyun