Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Moxifloxacin
IMED Healthcare Ltd.
J01MA; J01MA14
Moxifloxacin
400 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; moxifloxacin
Authorised
2018-03-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AVELOX 400 MG FILM-COATED TABLETS For use in adults. moxifloxacin 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 Avelox is and what it is used for 2. What you need to know before you take Avelox 3. How to take Avelox 4. Possible side effects 5. How to store Avelox 6. Contents of the pack and other information 1. WHAT AVELOX IS AND WHAT IT IS USED FOR Avelox contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infections. Avelox is used in patients of 18 years and older for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active. Avelox should only be used to treat these infections when usual antibiotics cannot be used or have not worked: Infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases). Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane. Avelox tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in addition to Avelox tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section _2. What you need to know _ _before you take Avelox, Warni Прочетете целия документ
Health Products Regulatory Authority 23 May 2022 CRN00CXNM Page 1 of 2 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. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister pack and outer packaging of the product as marketed in the country of origin. Health Products Regulatory Authority 23 May 2022 CRN00CXNM Page 2 of 2 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 Cartons containing colourless or white opaque polypropylene/aluminium blisters: The film-coated tablets are available in packs of 5 film-coated tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/118/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 th March 2018 10 DATE OF REVISION OF THE TEXT May 2022 Прочетете целия документ