Metronidazole 500 mg film-coated tablets

… r to any of the excipients listed in section 6.1. • 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). • Patients with Cockayne syndrome (see section 4.8)

• 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 in patients with epilepsy or those who have had seizures as high doses of Metronidazole can induce seizures. • Consideration of the therapeutic benefit against the risk of peripheral ne …

… ipheral neuropathy is advised with continuous therapy for chronic conditions. • There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. • 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 humans (see section 5.3), the use of metronidazole for longer treatment than usually required should be carefully considered. • Neuropathy …

• 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 in patients with epilepsy or those who have had seizures as high doses of Metronidazole can induce seizures. • Consideration of the therapeutic benefit against the risk of peripheral ne …

… high doses of Metronidazole can induce seizures. • Consideration of the therapeutic benefit against the risk of peripheral neuropathy is advised with continuous therapy for chronic conditions. • There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. • 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 …

… ed to nicotinamide adenine dinucleotide (NAD). The interference is due to the similarity in the absorption peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7. Information on sodium content This medicine contains less than 1 mmol sodium (23 mg) per each tablet, that is to say essentially 'sodium-free'.

… ipheral neuropathy is advised with continuous therapy for chronic conditions. • There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. • 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 humans (see section 5.3), the use of metronidazole for longer treatment than usually required should be carefully considered. • Neuropathy …

• Lithium: Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be tapered or withdrawn before administering metronidazole. Plasma concentration of lithium, creatinine, and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole. • Oral anticoagulant therapy (warfarin type): Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Dosage of the …

… creatinine should be closely monitored when coadministration is necessary. • 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 the potential for prolonging the QT interval.

There is inadequate evidence of the safety of metronidazole in pregnancy, but it has been in wide use for many years without apparent ill consequence. Nevertheless metronidazole, like other medicines, should not be given during pregnancy or during lactation unless it is considered essential; 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 trichomoniasis or bacteria …

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