Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metronidazole
Accord-UK Ltd
P01AB01
Metronidazole
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011100
ACCORD LOGO METRONIDAZOLE 200MG AND 400MG TABLETS 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. 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 1. WHAT METRONIDAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METRONIDAZOLE TABLETS 3. HOW TO TAKE METRONIDAZOLE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE METRONIDAZOLE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 1. WHAT METRONIDAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR Metronidazole tablets belong to a group of medicines called anti-infective agents. They may be used to TREAT : • infections, caused by bacteria of the blood, brain, bone, lung, stomach lining and pelvic area, following childbirth or in a wound following an operation • urinary or genital infections caused by a parasite, _Trichomonas_ • genital infection in women caused by bacteria • the parasitic diseases _amoebiasis_ • the disease _giardiasis_ • gum and teeth infections • infected leg ulcers or pressure sores • stomach ulcers caused by _Helicobacter pylori_ . • or PREVENT infections occurring after operations. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METRONIDAZOLE TABLETS DO NOT TAKE Metronidazole tablets and TELL your doctor if you: • are ALLERGIC (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients of this medicine (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • are in the FIRST 3 MONTHS OF PREGNANCY or are Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT METRONIDAZOLE TABLETS BP 200mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg Metronidazole PhEur. 3 PHARMACEUTICAL FORM White film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metronidazole is active against a wide range of pathogenic micro-organisms, notably species of _Bacteroids, Fusobacteria, Clostridia, Eubacteria_, anaerobic cocci and _Gardnerella vaginalis_. It is also active against _Trichomonas vaginalis, Entamoeba histolytica, Gardia _ _lamblia_, _Balantidium coli _and_ Helicobacter pylori_. Metronidazole is indicated in adults and children for the following indications: 1) Prevention of post-operative infections due to anaerobic bacteria, particularly species of _bacteroids_ and anaerobic streptococci. 2) The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated. 3) Urogenital trichomoniasis in the female (T_richomonas vaginalis_), and in man. 4) Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or _Gardnerella vaginalis_). 5) All forms of amoebiasis (intestinal and extra-intestinal disease and asymptomatic cyst passers). 6) Giardiasis. 7) Acute ulcerative gingivitis. 8) Acute dental infections (_eg_ acute pericoronitis and acute apical infections) 9) Anaerobically-infected leg ulcers and pressure sores. 10) Treatment of_ Helicobacter pylori_ infection associated with peptic ulcer as part of triple therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Metronidazole Tablets should be taken during or after meals, swallowed with water and NOT CHEWED. _ _ _Elderly_: Caution is advised in the elderly, particularly at high doses, although there is limited information available Lire le document complet