Metronidazol-BP

Metronidazolum

Each Metronidazole-BP 250 mg film-coated tablet contains metronidazole 250 mg. Each Metronidazole-BP 500 mg film-coated tablet contains metronidazole 500 mg. Excipient: wheat starch.

Indication: Treatment of infections caused by anaerobic bacteria and protozoa (Trichomonas, Entamoeba histolytica, Giardia lamblia, Balantidium), including genito-urinary tract infections, bacterial vaginosis, amoebiasis, giardiasis, postoperative infections, acute ulcerative gingivitis, trophic ulcers; prophylaxis of postoperative anaerobic infections; combination therapy of peptic ulcer disease for Helicobacter pylori eradication.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
Hypersensitivity to metronidazole, other 5-nitroimidazole derivatives, or to any of the excipients listed in section 6.1. First trimester of pregnancy. Concomitant use with disulfiram or ethanol (see section 4.5). Patients with wheat allergy (other than coeliac disease) (see section 4.4).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Metronidazole has no direct activity against facultative anaerobic or aerobic bacteria. It is possible for gonococcal infection to persist after Trichomonas vaginalis has been eliminated. Patients should be informed that metronidazole may darken the urine. Because of insufficient data on the risk of mutagenicity in humans, caution is recommended when using metronidazole for treatment longer than usual (see section 5.3).
Hepatotoxicity in patients with Cockayne syndrome
Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome, with very rapid onset after initiation of treatment, have been reported in patients with Cockayne syndrome receiving systemically administered medicinal products containing metronidazole. For this reason, in these patients […]