Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: SPONSOR: Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097
ARROW-ORNIDAZOLE is contraindicated in patients with known hypersensitivity to the medicine or to other nitroimidazole derivatives.
Ornidazole must be used with caution in patients with diseases of the CNS (e.g., epilepsy or multiple sclerosis) and liver disease.
The effect of other medicines can be intensified or impaired.
Alcohol must not be ingested when taking ornidazole or for at least 3 days after discontinuing the medicine.
Ornidazole potentiates the effect of coumarin type oral anticoagulants. The dosage of the anticoagulant has to be adjusted accordingly.
Caution must be exercised when taking ARROW-ORNIDAZOLE together with lithium, cimetidine and antiepileptic medicines such as phenytoin and phenobarbital. Ornidazole prolongs the muscle relaxant effect of vecuronium bromide.
There is no clinical data available for ornidazole exposure in pregnancy. Studies conducted on animals do not demonstrate direct or indirect harmful effects on pregnancy/embryonic/foetal development/birth or post-natal development. The effect of ornidazole on women of childbearing potential or birth control methods is unknown.
Extensive studies in various species have revealed no sign of any teratogenic or foetotoxic action of ornidazole. However, no controlled studies have been carried out in pregnant women. As a matter of principle, ARROW-ORNIDAZOLE should not be prescribed in early pregnancy or to nursing mothers except when absolutely necessary.
It is not known whether ornidazole is excreted in human milk. The excretion of ornidazole via milk in animals has not been researched. In making the decision whether or not to discontinue breastfeeding or whether or not ornidazole treatment should be discontinued/avoided, the benefit of breastfeeding to the infant and the benefit of ornidazole treatment for the nursing mother must be considered.
When ornidazole is administered at a high dosage of 400mg/kg/day, it produces infertility in male rats by inhibiting epididymal sperm motility in terms of decreased sperm velocity.
No data has been obtained from research involving humans.
Somnolence, dizziness, tremor, rigidity, poor coordination, seizures, vertigo or temporary loss of consciousness may occur in patients receiving ARROW-ORNIDAZOLE. If they occur, such effects may affect tasks requiring alertness including the patient’s ability to drive and operate machinery.
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)
Rare: Leukopenia
Very rare: Somnolence, headache, dizziness, tremor, rigidity, coordination impairments, seizures, fatigue, vertigo, temporary loss of consciousness and sensory or mixed peripheral neuropathy.
Uncommon: Nausea, vomiting, diarrhoea, epigastric discomfort, dry mouth, loss of appetite.
Rare: Impairment of the sense of taste
Unknown: Jaundice, abnormal liver function tests
Rare: Pruritus and skin reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions (https://nzphvc.otago.ac.nz/reporting/).
Not applicable.
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