Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
NABUMETONE
Imbat Limited
M01AX01
NABUMETONE
500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
nabumetone
Authorised
2009-11-13
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER RELIFEX ® 500MG FILM-COATED TABLETS (nabumetone) The name of your medicine is Relifex 500mg film coated tablets, but will be referred to as Relifex tablets throughout this leaflet. 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 Relifex tablets are and what they are used for 2. What you need to know before you take Relifex tablets 3. How you take Relifex tablets 4. Possible side effects 5. How to store Relifex tablets 6. Contents of the pack and other information 1. WHAT RELIFEX TABLETS ARE AND WHAT THEY ARE USED FOR Relifex tablets contain the active ingredient nabumetone, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Relifex tablets are used for the management of arthritis such as: Osteoarthritis Rheumatoid arthritis Spondylitis (inflammation of the spine) Gout (inflammation of a joint - often the big toe) and Muscle injuries 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RELIFEX TABLETS DO NOT TAKE RELIFEX TABLETS: If you are allergic to Nabumetone. If you have experienced asthma, hives or an allergic reaction to other similar drugs (NSAIDs). If you are allergic to any of the other ingredients of Relifex tablets (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. If you have or have had a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach (2 Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Relifex 500mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg of nabumetone. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK:_ Dark red, film-coated tablets marked “Relifex” on one side and “500” on the other. 4 CLINICAL PARTICULARS As per PA1051/001/001 5 PHARMACOLOGICAL PROPERTIES As per PA1051/001/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium starch glycollate Sodium lauryl sulphate Hypromellose Magnesium stearate Microcrystalline cellulose Saccharin sodium Liquid caramel flavour Red carmine (E120) Iron oxide yellow (E172) Titanium dioxide (E171) Talc Polyethylene glycol 400 Carnauba wax 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _6_ _5_ _7_ _9_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Keep the tablets in the original container in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing a plastic bottle with a screw top cap. Pack size: 56 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE Διαβάστε το πλήρες έγγραφο