Sertadie 300 mg Sertaconazole nitrate Candidase 1 Vaginal Ovule

SERTADIE * 1 OV VAG 300MG

Therapeutic indications

Local treatment of clinically established vaginal candidiasis.

Dosage and method of use

Introduce the egg deeply into the vagina, preferably in the supine position, in the evening at bedtime. The treatment involves a single administration. In case of persistence of the symptoms, a second egg can be introduced after 7 days.

Contraindications

Hypersensitivity to components or other closely related substances from a chemical point of view. In particular towards the antifungals of the imidazole group. Generally contraindicated in pregnancy and lactation (see section 4.6).

Side effects

Rarely have been reported manifestations of local intolerance, such as a burning sensation or itching, which usually resolved spontaneously. Allergy phenomena are possible. An increase in liver enzymes has rarely been reported.

Special warnings

In the case of candidiasis also involving the vulvar and / or perianal areas, it is recommended to combine the therapy with sertaconazole in ovules for vaginal use with local treatment with another antifungal. In order to prevent reinfections with the so-called ping-pong mechanism, treatment of the partner with antifungals is also essential. For local hygiene we recommend the use of soaps with neutral or alkaline pH, as soaps with acidic pH can favor the proliferation of Candida. In case of local intolerance or allergic reaction, the treatment must be interrupted and the removal of the residual product can be carried out by vaginal irrigations. The use of the product may interfere with the effectiveness of latex contraceptive devices (condoms and diaphragms) as it can cause them to break. The product can also be used in the menstrual period.

Pregnancy and breastfeeding

Imidazole antifungals, despite their minimal systemic absorption, are generally not recommended during pregnancy as adverse effects on the fetus have been reported in animal studies. However, studies carried out with sertaconazole on various animal species have not shown embryotoxic and / or teratogenic effects. There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.

Expiration and retention

Do not store above 30 ° C.

Interactions with other drugs

The concomitant use of spermicides is not recommended, as the product may reduce or inactivate their contraceptive activity

Overdose

Phenomena related to drug overdose are not foreseeable

Active principles

One egg contains: active substance : sertaconazole nitrate 300 mg For a full list of excipients, see section 6.1.

Excipients

Solid semisynthetic glycerides (WITEPSOL H19), solid semisynthetic glycerides (SUPPOCIRE NAI-50), anhydrous colloidal silica.