Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2010 Publisher: Recordati Industria Chimica e Farmaceutica SpA, Via Matteo Civitali, 1-20148, Milano, Italy
Ascertained hypersensitive to the product and to other imidazole derivatives.
The product should not be used in conjunction with barrier contraceptives.
In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and the physician consulted.
Not investigated. Since systemic absorption of fenticonazole after application is low, interactions with other drugs are unlikely.
Oral administration of fenticonazole in rats has been reported to produce prolonged gestation and embryotoxic effects after doses above 40mg/kg/day. Fenticonazole does not interfere with the function of male and female gonads and does not modify the first phases of reproduction.
Fenticonazole has shown no teratogenic effects in rats and rabbits. Fenticonazole or its metabolites cross the placental barrier in pregnant rats and rabbits after vaginal application and are excreted in milk of lactating rats.
Since there is no experience of use during pregnancy or lactation, Gynoxin should not be used unless the physician considers it essential to the welfare of the patient.
Pregnant women should not use an applicator without medical instruction.
None.
After intravaginal administration slight transient burning, which usually disappears rapidly, may occasionally occur.
Prolonged topical application may cause sensitisation reactions.
None.
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