Fucis®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FUSIS® (FUSYS®)

Composition:

Active substance: fluconazole;

1 g of gel contains 5 mg of fluconazole;

Excipients: carbomer, propylene glycol, polysorbate 80, octyldodecanol, benzyl alcohol, sodium hydroxide, flavoring agent Delite, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: colorless transparent or opaque homogeneous gel with a characteristic odor.

Pharmacotherapeutic group.

Antifungal agents for topical use. Triazole derivatives. ATC code J02A C01.

Pharmacological Properties.

Pharmacodynamics.

Fluconazole is an antifungal agent of a new class of triazole compounds, a potent selective inhibitor of sterol synthesis in fungal cells.

Its activity has been demonstrated in fungal infections such as Candida spp. (including systemic candidiasis in immunocompromised animals), Cryptococcus neoformans (including intracranial infections); Microsporum spp. and Trichophyton spp.

Topically, fluconazole is used as an agent with a broad antifungal spectrum of activity.

Its activity has been demonstrated against dermatophytes and yeasts.

Fluconazole is highly specific to fungal cytochrome P450 enzymes. It inhibits the enzyme lanosterol-14α-demethylase, which converts lanosterol into ergosterol, a sterol present in fungal cell membranes.

Pharmacokinetics.

Pharmacokinetic studies of fluconazole gel have shown that plasma fluconazole levels are so low that systemic action of the drug is excluded.

Pharmacokinetic studies of fluconazole gel in children have not been conducted, but studies in adults have shown that the drug is absorbed systemically to a negligible extent.

Studies conducted to assess skin tolerance and phototoxicity have shown that fluconazole gel is well tolerated by human skin and does not exhibit phototoxic effects.

Clinical characteristics.

Indications.

Dermatomycoses caused by yeasts and dermatophytes, namely: tinea pedis, trichophytia of smooth skin, tinea cruris, pityriasis versicolor, and infections caused by fungi of the genus Candida.

Contraindications.

Hypersensitivity to fluconazole or to azole compounds closely related to it in chemical structure, as well as to any excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

There are no reports regarding interaction or incompatibility with other medicinal products. Specific studies on the interaction of fluconazole with other medicinal products have not been conducted. Do not apply simultaneously with other topical agents on the skin.

Special precautions for use.

Prolonged use, especially long-term, of topical medications, including Fucis®, may lead to sensitization and adverse effects. In such cases, treatment should be discontinued and medical advice should be sought.

Fucis® gel must not be used in ophthalmology.

The medicinal product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the medication should be used only if the expected benefit to the mother outweighs the potential risk to the fetus or infant, and under direct medical supervision.

Effect on the ability to drive or operate machinery.

No effect.

Method of Administration and Dosage.

Apply the medication once daily, gently rubbing it into the affected areas of the skin and surrounding regions. On intertriginous areas, apply the gel in small amounts and thoroughly rub it over the entire affected surface to avoid maceration.

The duration of therapy required for healing varies depending on the etiological factors and the location of the affected area. In most patients, 1–3 weeks of treatment with the drug are usually sufficient for healing.

The treatment period for resistant forms may be extended up to 6 weeks. The duration of treatment should be determined by a physician.

Children.

There is no data available regarding the use of the medication in children.

Overdose.

There have been no reports of overdose cases.

Adverse Reactions

Immune system disorders: hypersensitivity reactions (including urticaria, angioedema, pruritus, and skin rashes).

Skin disorders: skin irritation.

If such reactions occur, treatment should be discontinued.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is an important procedure. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report all suspected adverse reactions to the State Expert Centre of the Ministry of Health of Ukraine and to the marketing authorization holder via the feedback form on the website: https://kusum.ua/pharmacovigilance/.

Shelf life: 3 years.

Storage conditions

Store at temperatures not exceeding 25 °C in the original packaging. Do not freeze.

Keep out of reach and sight of children.

Packaging

30 g of gel in a tube, 1 tube per cardboard pack.

Pharmaceutical category

Over-the-counter (without prescription).

Manufacturer

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and place of business

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.