SERTACONAZOLE-PHARMEX

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SERTACONAZOLE-PHARMEX (Sertaconazole-Pharmex)

Composition:

Active substance: sertaconazole;

1 suppository contains sertaconazole nitrate 300 mg;

Excipients: colloidal anhydrous silicon dioxide, hard fat.

Pharmaceutical form. Suppositories.

Main physicochemical properties: smooth, white or almost white, torpedo-shaped suppositories. On longitudinal section, no specks are present; a cup-shaped depression and an air channel may be observed.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATC code G01AF19.

Pharmacological properties.

Pharmacodynamics.

Sertaconazole is an antifungal agent, an imidazole derivative, with high fungicidal activity, intended for topical use in gynecology. Its mechanism of action involves inhibition of ergosterol synthesis and increased cell membrane permeability, leading to destruction of pathogens. It is effective against pathogenic yeast fungi (Candida albicans, Candida spp., and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton, and Microsporum spp.), and causative agents of skin and mucous membrane infections, including gram-positive strains (Staphylococcus, Streptococcus).

Pharmacokinetics.

Systemic absorption is absent.

Clinical characteristics.

Indications. Local treatment of vaginal candidiasis.

Contraindications.

Known hypersensitivity to antifungal agents, imidazole derivatives, or to any of the excipients of the drug.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of suppositories with topical contraceptives may reduce their spermicidal effect.

Concomitant use with latex condoms or diaphragms is not recommended due to the risk of damage to these devices.

Special precautions for use.

During treatment, it is not recommended to use soap with an acidic pH; it is preferable to wear underwear made predominantly of cotton and to avoid douching.

It is also advisable to apply an antifungal cream containing sertaconazole to the area of the vulva and perineum.

Sexual intercourse should be avoided during the use of the drug. Simultaneous treatment of the sexual partner should be considered.

Treatment may be carried out during menstruation.

Predisposing factors (hygienic or lifestyle-related) contributing to the development and manifestation of fungal infection should be identified and eliminated.

Concomitant treatment of other pathogenic microorganisms associated with candidiasis is also recommended.

Treatment should be discontinued if local allergic reactions occur.

In the absence of typical clinical signs of vaginal candidiasis, a positive microbiological finding alone is not an indication for treatment.

Use during pregnancy or breastfeeding.

There are no data regarding embryotoxic or teratogenic effects of sertaconazole. Due to the route of administration (single treatment dose) and the absence of systemic absorption of the drug, sertaconazole may be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

There are also no data on the passage of sertaconazole into breast milk. Therefore, during breastfeeding, the drug should not be used except in cases where, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the infant.

Ability to affect reaction rate while driving or operating machinery.

Does not affect.

Method of Administration and Dosage

Adults: 1 suppository should be administered deeply into the vagina in the evening before bedtime, once daily. If clinical symptoms of the disease do not resolve, repeat administration of the drug may be performed after 7 days.

Children

Sertaconazole-Pharmex is not used in children.

Overdose

Overdose is almost impossible following vaginal administration.

Adverse reactions.

A transient local irritant reaction (burning sensation and itching) may occasionally occur. This may be due to cellular fragment activity following pathogen destruction, so such a reaction could be a sign of successful therapy. Allergic reactions are also common.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

1 suppository per blister. 1 blister per cardboard box.

Prescription status. Prescription only.

Manufacturer. LLC "FARMEKS GROUP", Ukraine.

Manufacturer's address and location of business activity.

100 Shevchenka Street, Boryspil, Kyiv region, Ukraine, 08301.

All cases of adverse reactions must be reported to the manufacturer:

LLC "Farmeks Group", Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100, tel. +38(044)391-19-19, fax: +38(044)391-19-18, or via the form on the website: https://www.pharmex.com.ua/ua/files/f137o.doc