Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Metronidazole must not be used in patients with Cockayne syndrome. Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.
… 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 cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of encephalopathy.
Metronidazol …
Identical in both labels. Surrounding text shown from Morningside Healthcare Ltd.
… ith caution in patients with active or chronic severe peripheral and central nervous system disease due to the risk of neurological aggravation.
Hepatotoxicity in patients with Cockayne Syndrome
Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use. In this population, metronidazole should not be used unless the benefit is considered to outweigh the risk and if no alternative treatment is available. Liver function tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached. If the liver function tests become markedly elevated during treatment, the drug should be discontinued.
Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole (see section 4.8).
Cases of severe bu …
Liver disease:
Caution is needed in patients with severe hepatic impairment. The dose of metronidazole should be reduced as necessary. Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairm …
… 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 …
… 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 with hepatic impairment
In patients with severe liver damage metronidazole should only be used if its expected benefits clearly outweigh potential hazards.
Metronidazole is mainly metabolised by hepatic oxidation. Substa …
Regular clinical and laboratory monitoring (including full blood count) are advised in cases of high-dose or prolonged treatment, in case of antecedents of blood dyscrasia, in case of severe infection and in severe hepatic insufficiency.
In patients with severe liver damage or impaired haematopoiesis (e.g. granulocytopenia) metronidazole should only be used if its expected benefits clearly outweigh potential hazards.
Metronidazole …