Kandiklin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CANDICLIN

Composition:

Active substance: sertaconazole;

1 suppository contains sertaconazole nitrate 300 mg;

Excipients: colloidal anhydrous silicon dioxide, hard fat.

Dosage form. Suppositories.

Basic physicochemical properties: oval, white or almost white suppositories.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATC code G01AF.

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 pathogens causing skin and mucous membrane infections, including gram-positive strains (Staphylococcus, Streptococcus).

Pharmacokinetics.

Systemic absorption is absent. After vaginal administration, plasma concentrations of the active substance do not reach the limit of detection. No radioactivity was detected in plasma after vaginal administration of radiolabeled sertaconazole.

Clinical characteristics.

Indications.

Local treatment of vaginal candidiasis.

Contraindications.

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

Concomitant use of the product with latex condoms or diaphragm.

Interaction with other medicinal products and other forms of interaction.

When diaphragms are used concomitantly with topical contraceptives, a reduction in their spermicidal effect may occur.

Concomitant use with latex condoms or diaphragm is contraindicated due to the risk of their damage.

Special precautions for use.

If the diagnosis of candidiasis has been confirmed, predisposing factors (hygienic or lifestyle-related) that promote the development and manifestation of fungal infection should be identified and eliminated.

During treatment, to prevent recurrences, the use of acidic pH soaps and douching is not recommended. It is advisable to wear predominantly cotton underwear.

It is also appropriate to apply an antifungal cream containing sertaconazole to the vulvar and perineal areas.

Sexual intercourse should be avoided during treatment with the medicinal product.

Simultaneous treatment of the sexual partner should be considered.

Treatment may be carried out during menstruation.

It is also recommended to treat other pathogenic microorganisms that may be associated with candidiasis.

Treatment should be discontinued if local allergic reactions occur.

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

Use during pregnancy or breastfeeding.

There are no data regarding embryotoxicity 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 if the expected benefit to the woman outweighs the potential risk to the fetus.

There are no data on the passage of sertaconazole into breast milk. 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 influence reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

For adults: insert 1 suppository deeply into the vagina, preferably while lying on the back, once daily in the evening before bedtime. If clinical symptoms of the disease do not resolve, repeat administration of the drug may be considered after 7 days.

Children.

Sertaconazole is not intended for use in children.

Overdose.

Overdose has not been practically observed following vaginal administration.

Side effects.

Immune system disorders: transient local irritation (burning sensation and itching) may sometimes occur. This may be due to the action of cellular fragments released during pathogen destruction; therefore, such a reaction may be a sign of successful therapy.

Allergic reactions occur frequently.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product.

Shelf life: 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

1 suppository in a strip made of polyvinyl chloride film. 1 strip in a carton.

Prescription status.

Prescription only.

Manufacturer.

JSC "Monfarm", Ukraine.

Manufacturer's address and place of business.

Avramivka village, Zavodska St., 8, Uman district, Cherkasy region, 19161, Ukraine