País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
MOXIFLOXACIN HYDROCHLORIDE
Lexon (UK) Ltd
J01MA14
MOXIFLOXACIN HYDROCHLORIDE
400 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
moxifloxacin
Authorised
2017-07-21
CONTENTS OF THE PACK AND OTHER INFORMATION WHAT AVELOX CONTAINS • The active substance is moxifloxacin. Each film-coated tablet contains 400 milligram moxifloxacin as hydrochloride. • The other ingredients are: Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate _(see section Avelox _ _contains lactose)_ and magnesium stearate. Film coating: hypromellose, macrogol 4000, ferric oxide (E172), titanium dioxide (E171) WHAT AVELOX LOOKS LIKE AND CONTENTS OF THE PACK Each dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 x 7 mm, and marked with “M400” on one side and “BAYER” on the other side. Avelox is available in packs containing 5 film-coated tablets. Product procured from within the EU, repackaged and distributed by the Parallel Product Authorisation Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK. THE MANUFACTURER IS: Bayer AG, D-51368 Leverkusen, Germany. Avelox is a registered trademark of Bayer AG. PPA1097/025/001 Revision date: 09/04/2018 Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: +44 (0)1527 505414 for help. THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA UNDER THE FOLLOWING NAMES: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovak Republic, Slovenia, Sweden, United Kingdom: AVELOX France: IZILOX Germany, Italy: AVALOX AVELOX 400 MG FILM-COATED TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT • allergic reaction • increase of bilirubin in the blood • inflammation of the stomach • dehydration • severe heart rhythm abnormalities • dry skin • angina pectoris RARE (may affect up to 1 in 1,000 people) • muscle twitching • muscle cramp • hallucination • high blood pressure • swelling (of the hands, feet, ankles, lips, mouth, throat) • low blood pressure Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Avelox 400 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride). Excipient with known effect: The film-coated tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Greece_ Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 x 7 mm, and marked with “M400” on one side and “BAYER” on the other side. 4 CLINICAL PARTICULARS As per PA1410/027/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/027/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Film-coat: Hypromellose Macrogol 4000 Ferric oxide (E172) Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable. 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_ _4_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _3_ _6_ _9_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date for 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 Do not store above 25°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER The film-coated tablets are Llegiu el document complet