Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.
White polypropylene container with tamper evident polyethylene closure: 3 years.
Amber polypropylene bottle with polyethylene closure: 3 years.
PVC/Aluminium blisters: 2 years.
PVdC coated PVC/Aluminium blisters: 3 years.
Not applicable.
Povidone
Magnesium Stearate
Colloidal Anhydrous Silica
Maize Starch
The frequency of adverse events listed below is defined using the following convention:
Very common (>1/10); common (>1/100 to < 1/10); uncommon (>1/1,000 to < 1/100); rare (>1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Serious adverse reactions occur rarely with standard recommended regimens. Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.
Blood and lymphatic system disorders:
Very rare: agranulocytosis, neutropenia, thrombocytopenia, and pancytopenia
Not known: leucopenia.
Immune system disorders:
Rare: anaphylaxis,
Not known: angioedema, urticaria, fever.
Metabolism and nutrition disorders:
Not known: anorexia.
Psychiatric disorders:
Very rare: Psychotic disorders, including Confusion and hallucinations.
Not known: depressed mood
Nervous system disorders:
Very rare:
- Encephalopathy (eg. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (eg. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug.
- Drowsiness, dizziness, convulsions, headaches
Not known:
- during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.
- Aseptic meningitis
Eye disorders:
Very rare: vision disorders such as diplopia and myopia, which, in most cases, is transient.
Not known: optic neuropathy/neuritis
Ear and labyrinth disorders:
Not known: hearing impaired/hearing loss (including sensorineural), tinnitus
Gastrointestinal disorders:
Not known: Taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastro-intestinal disturbances such as epigastric pain and diarrhoea.
Hepatobiliary disorders:
Very rare:
- increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, jaundice and pancreatitis which is reversible on drug withdrawal.
- Cases of Liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs
Skin and subcutaneous tissue disorders:
Very rare: skin rashes, pustular eruptions, pruritis, flushing
Not known: erythema multiforme, Steven-Johnson syndrome or toxic epidermal necrolysis, fixed drug eruption.
Musculoskeletal, connective tissue and bone disorders:
Very rare: myalgia, arthralgia.
Renal and urinary disorders:
Very rare: darkening of urine (due to metronidazole metabolite).
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Metronidazole has been shown to be carcinogenic in the mouse and in the rat following chronic oral administration however similar studies in the hamster have given negative results. Epidemiological studies have provided no clear evidence of an increased carcinogenic risk in humans.
Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while other studies were negative.
Pharmacotherapeutic group: Antibacterials for systemic use, ATC code: J01X D01
Metronidazole is active against a wide range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis. It is also active against Trichomonas, Entamoeba histolytica, Giardia lamblia and Balantidium coli.
Metronidazole is rapidly and almost completely absorbed on administration of Metronidazole tablets; peak plasma concentrations occur after 20 min to 3 hours.
The half-life of metronidazole is 8.5 ± 2.9 hours. Metronidazole can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole is excreted in milk but the intake of a suckling infant of a mother receiving normal dosage would be considerably less than the therapeutic dosage for infants.
06/04/2017
Milpharm Limited,
Ares,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
Containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Bottle: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Blisters: Do not store above 25°C. Store in the original package.
White polypropylene container with tamper evident polyethylene closure:1000, 500, 250, 100, 84, 70, 56, 42, 28, 21, 15, 14 and 7 tablets.
Amber polypropylene bottle with polyethylene closure: 50 tablets.
PVC/Aluminium blisters: 7, 14, 15, 21, 28, 42, 56, 70 and 84 tablets.
PVdC coated PVC/Aluminium blisters: 7, 14, 15, 21, 28, 42, 56, 70 and 84 tablets.
Not all pack sizes may be marketed
PL 16363/0025
No special requirements.
27/02/2009
