Antifungal-antibacterials (imidazole antifungals).

Miconazole nitrate

Each pessary contains 100 mg miconazole nitrate

Vaginal pessaries. The pessaries are white to beige coloured and egg-shaped

For the local treatment of vulvovaginal candidosis and superinfections due to gram-positive bacteria.

Gyno-Daktarin pessaries are for vaginal administration.

Adults and elderly

One pessary to be inserted deeply into the vagina. This is best done in the reclining position. Repeat this procedure once daily for 14 days or 1 pessary twice daily for 7 days. Continue the course of treatment, even after pruritus and leukorrhoea have disappeared or menstruation begins.

Not applicable.

Gyno-Daktarin pessaries are contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient of the pessaries.

Should local sensitisation or an allergic reaction occur, treatment should be discontinued.

Appropriate therapy is indicated when the sexual partner is also infected.

Gyno-Daktarin pessaries do not stain skin or clothes.

The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Gyno-Daktarin pessaries should not be used concurrently with a latex condom or latex diaphragm.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and also CYP3A4 (e.g., HMG-CoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised.

Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin pessaries since the constituents may be damage the latex.

Adverse reactions are rare and are mild in most cases.

Most frequently reported were local irritation, pruritus and burning sensation, especially at the start of treatment. Complaints of pelvic cramps, hives, skin rash have also been reported.

Janssen-Cilag Ltd

(POM)

14 May 2009