Flucovag (Suppositories) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Altpharm LLC (Russia)

ATC Code

G01AF (Imidazole derivatives)

Active Substance

Sertaconazole (Rec.INN WHO registered)

Dosage Form

Flucovag

Vaginal suppositories 300 mg: 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories from white to white with a yellowish or grayish tint, oval in shape, without visible inclusions and inhomogeneities; the longitudinal section may have an air core and/or a funnel-shaped depression.

Excipients: solid fat (witepsol, grade H19) – 1.305 g, solid fat (suppocire, grade NAI50) – 1.305 g, colloidal anhydrous silicon dioxide – 0.09 g.

1 pc. – contour cell packaging (1) – cardboard packs.
1 pc. – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

A drug with antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; imidazole derivatives

Pharmacological Action

Antifungal agent, a derivative of imidazole and benzothiophene. In therapeutic doses, it has a fungistatic and fungicidal effect. The mechanism of action consists in the inhibition of ergosterol synthesis and an increase in the permeability of the fungal cell membrane, which leads to lysis of the fungal cell.

Active against Candida spp. It also has antibacterial activity against gram-positive bacteria (Streptococcus spp., Staphylococcus spp.).

Pharmacokinetics

When applied intravaginally, the drug is not absorbed.

Indications

Local treatment of infections of the vaginal mucosa caused by fungi of the genus Candida (candidal vulvovaginitis).

ICD codes

Dosage Regimen

Administer intravaginally as a single dose of one 300 mg suppository.

Insert the suppository deeply into the vagina, preferably at bedtime to facilitate absorption and minimize leakage.

If clinical symptoms persist, administer a second dose after an interval of 7 days.

Complete the full course of treatment even if symptoms improve after the initial administration.

For concurrent infection of the vulva ( candidal vulvitis), apply a topical sertaconazole cream to the affected external areas.

Treatment can be initiated and continued during menstruation; use appropriate sanitary protection.

Refrain from sexual intercourse during the treatment period.

Consider concurrent treatment of the sexual partner to prevent reinfection.

Be aware that simultaneous use with latex barrier contraceptives (condoms, diaphragms) may increase the risk of damage, reducing their contraceptive and protective efficacy.

Adverse Reactions

Immune system disorders frequency unknown – allergic reactions are possible.

Reproductive system and breast disorders rarely – burning sensation, itching in the vagina, which resolve on their own during treatment and do not require discontinuation of therapy. These side effects are classic for topical preparations and reflect the effectiveness of the drug.

Contraindications

Hypersensitivity to imidazole derivatives, benzothiophene.

Use in Pregnancy and Lactation

There are insufficient data on the use of sertaconazole during pregnancy and breastfeeding.

Given that this agent is administered as a single dose, as well as the absence of systemic absorption after intravaginal administration, use during pregnancy and breastfeeding is possible if the potential benefit to the mother outweighs the possible risk to the fetus or child.

Special Precautions

In case of simultaneous infection of the labia and adjacent areas (candidal vulvitis), additional local treatment with topical sertaconazole should be carried out.

It is recommended to refrain from sexual intercourse during treatment.

To prevent urogenital reinfection, it is recommended to consider simultaneous treatment of the sexual partner.

The risk of damage to barrier contraceptive devices (rupture of a condom or diaphragm) increases with their simultaneous use with this agent.

Treatment can be carried out during menstruation.

Effect on ability to drive vehicles and operate machinery

The use of sertaconazole does not affect the ability to perform potentially hazardous activities requiring high concentration and speed of psychomotor reactions (including driving vehicles).

Drug Interactions

With simultaneous use with local contraceptives, a weakening of the spermicidal effect of the latter may be observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.