Metronidazole 500 mg Film-Coated Tablets

… tronidazole or any of the ingredients in the tablets. • Pregnancy - metronidazole should not be used in the first trimester in patients with trichomoniasis or bacterial vaginosis (see section 4.6). • Breast feeding should be discontinued for 12-24 hours when single high dose (e.g. 2g) therapy is used (see section 4.6).

Contains wheat starch. Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine. Patients should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. A disulfiram-like reaction with hypotension and flushing has occurred (see section 4.5). Caution is advised in patients with porphyria. Metronidazole tablets should not be used in patients with blood dyscrasias or with active non-infectious disease of the central nervous system. High d …

… l nervous system. High doses of metronidazole may mask the presence of syphilis. Caution in patients with epilepsy or those who have had seizures as high doses of Metronidazole can induce seizures. Use with caution in the second and third trimester when used to treat trichomoniais or bacterial vaginosis (see section 4.6.) There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. The elimination half-life of metronidazole remains unchanged in the presence of ren …

… renal failure. The dosage of metronidazole, therefore, needs no reduction. Such patients, however, retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight-hour period of dialysis. Metronidazole should, therefore, be readministered immediately after haemodialysis. No routine adjustment in the dosage of metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IPD) or continuous ambulatory peritoneal dialysis (CAPD) …

… o routine adjustment in the dosage of metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IPD) or continuous ambulatory peritoneal dialysis (CAPD). Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant accumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to symptoms of the encephalopathy. Therefore, metronidazole should be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine. For information on renal and hepatic insufficiency, please see section 4.2. Due to inadequate evidence on the mutagenicity risk in hum …

Contains wheat starch. Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine. Patients should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. A disulfiram-like reaction with hypotension and flushing has occurred (see section 4.5). Caution is advised in patients with porphyria. Metronidazole tablets should not be used in patients with blood dyscrasias or with active non-infectious disease of the central nervous system. High d …

… o have had seizures as high doses of Metronidazole can induce seizures. Use with caution in the second and third trimester when used to treat trichomoniais or bacterial vaginosis (see section 4.6.) There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole, therefore, needs no reduction. Such patients, however, retain the metaboli …

… ts should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. A disulfiram-like reaction with hypotension and flushing has occurred (see section 4.5). Caution is advised in patients with porphyria. Metronidazole tablets should not be used in patients with blood dyscrasias or with active non-infectious disease of the central nervous system. High doses of metronidazole may mask the presence of s …

… rimester when used to treat trichomoniais or bacterial vaginosis (see section 4.6.) There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole, therefore, needs no reduction. Such patients, however, retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight-hour period of dialysis. Metronidazole should, therefore, be readministered immediately aft …

Contains wheat starch. Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine. Patients should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. A disulfiram-like reaction with hypotension and flushing has occurred (see section …

… tes the metabolism of Metronidazole causing reduced plasma concentrations. • Cytotoxics: Metronidazole inhibits metabolism of fluorouracil. Therefore, increased toxicity of fluorouracil can result. • Ulcer-healing drugs: Cimetidine inhibits the metabolism of metronidazole (increases plasma-metronidazole concentration). • Oestrogens: broad spectrum antibiotics possibly reduce the contraceptive effect. • Drug-lab modifications: Aspartate amino transferase assays may give spuriously low values in patients taking metro …

… possibly reduce the contraceptive effect. • Drug-lab modifications: Aspartate amino transferase assays may give spuriously low values in patients taking metronidazole, depending on the method used. • Busulfan : Plasma levels of busulfan may be increased by metronidazole which may lead to severe busulfan toxicity. Drugs that prolong QT interval: QT prolongation has been reported, particularly when metronidazole was administered with drugs with potential for prolonging the QT interval.

As with all medicines, metronidazole should not be given during pregnancy or during lactation unless it is considered essential, and in these circumstances the short, high- dosage regimens are not recommended. Pregnancy Metronidazole is contraindicated in the first trimester (see section 4.3) and should be used with caution in the second and third trimester when used to treat trichomoniais or bacterial …

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