GYNO TROSYD 300 mg Ov B

Tioconazole........................................................................................................................................... 300,00 mg

For one ovule.

Local treatment of vaginal mycoses, in particular candida.

Dosage

Single administration of one ovule of Gyno Trosyd 300 mg.

Method of administration

The ovule should be placed deep in the vagina, in the evening at bedtime.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Warning

The oily nature of the excipients in this preparation may deteriorate the rubber of male condoms or diaphragms.

Precautions for use

In case of a hypersensitivity reaction, application should be discontinued.

Combinations not recommended

Spermicides

Any local vaginal treatment may inactivate a local spermicidal contraceptive.

Pregnancy

Although no teratogenic effect has been observed in animal studies, experience in pregnant women is insufficient to permit a recommendation for the use of tioconazole during the first trimester of pregnancy.

Some signs of local irritation (pruritus, burning sensations, vulvar oedema) have been reported, most often moderate and transient.

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 national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr

No overdose has been reported.

However, excessive use may lead to an exacerbation of adverse effects.

Pharmacotherapeutic class: ANTIFUNGAL (imidazole class) ATC code: G01AF08

Tioconazole has an extended antifungal spectrum: in vitro, it inhibits the growth of yeasts, such as candida and torulopsis.

It is also active in vitro against gram-positive organisms, in particular staphylococci, streptococci, Gardnerella vaginalis, Bacteroides and Trichomonas vaginalis.

During clinical studies, the activity of tioconazole was verified in the treatment of infections due to Candida and Torulopsis glabrata.

Absorption

The absorption of tioconazole through the vaginal mucosa is low.

Elimination

Tioconazole disappears rapidly from the bloodstream, which makes it possible to rule out the occurrence of systemic effects.

Tioconazole is found in vaginal secretions 48 hours after insertion of the ovule.

3 years

No special precautions for storage.

No special requirements.