FUNGOSEPT®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Fungosept® (Fungosept®)

Composition:

Active substance: amorolfine;

1 ml of the preparation contains 50 mg of amorolfine as amorolfine hydrochloride;

Excipients: ammonium methacrylate copolymer type A (Eudragit RL 100), ethyl acetate, butyl acetate, triacetin, anhydrous ethanol.

Pharmaceutical form. Therapeutic nail lacquer.

Main physicochemical properties: clear, colorless or almost colorless liquid.

Pharmacotherapeutic group.

Other antifungal agents for topical use. ATC code D01AE16.

Pharmacological properties.

Pharmacodynamics.

Fungosept**®**, nail lacquer for treatment, is an antifungal agent intended for topical use. Amorolfine belongs to a new class of chemical compounds; its fungicidal action is based on altering the fungal cell membrane, primarily through its effect on sterol biosynthesis. The content of ergosterol decreases, while at the same time atypical, non-planar sterol compounds accumulate, leading to morphological changes in cellular membranes and organelles, resulting in fungal cell death.

Amorolfine is a broad-spectrum antifungal agent. It is highly active against common or occasional causative agents of onychomycosis, such as:

yeast fungi: Candida albicans and other Candida species;

dermatophytes: Trichophyton rubrum, Trichophyton interdigitale, and Trichophyton mentagrophytes, other Trichophyton species; Epidermophyton floccosum; Microsporum;

molds: Scopulariopsis;

dematiaceous (dark) fungi: Hendersonula, Alternaria, Cladosporium;

species with lower sensitivity: Aspergillus, Fusarium, Mucorales.

Bacteria, except for actinomycetes, are insensitive to amorolfine.

Pharmacokinetics.

Amorolfine from the nail lacquer penetrates into the nail plate and diffuses through it, thus being able to eradicate fungi located in the nail bed that are difficult to reach. Systemic absorption of the active ingredient following this application is very low, and its plasma concentration remains below the detection limit even after one year of use.

Clinical characteristics.

Indications.

For the treatment of onychomycosis without nail matrix involvement (onychostroma) as first-line therapy.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Available data to date indicate no clinically significant interactions.

Special precautions for use

Do not apply Fungosept® on the skin around the nail. Avoid contact of the lacquer with eyes, ears, and mucous membranes.

The medicinal product should also be used with caution in patients with conditions that predispose them to nail damage (peripheral circulation disorders, diabetes mellitus, and immunosuppression), as well as in patients with nail dystrophy and severely damaged nails (more than two-thirds of the nail plate destroyed). In such cases, consult a physician and consider the possibility of systemic treatment.

Do not use artificial nails during application of Fungosept® lacquer.

When working with organic solvents, wear impermeable gloves to prevent dissolution of the lacquer. Cosmetic nail polish may be applied no sooner than 10 minutes after application of Fungosept® lacquer. Before reapplying Fungosept® lacquer, carefully remove any cosmetic nail polish.

If a systemic or local allergic reaction occurs, discontinue use of the medicinal product immediately and consult a physician. The product should be thoroughly removed using a nail polish remover. The medicinal product must not be reapplied.

Use during pregnancy or breastfeeding

There is limited data on the use of amorolfine during pregnancy and breastfeeding. Post-marketing reports include only a small number of pregnant women who have used topical amorolfine, therefore the potential risk is unknown. Animal studies have shown reproductive toxicity when the drug was administered orally at high doses.

It is not known whether amorolfine passes into breast milk. Fungosept® should not be used during pregnancy and breastfeeding, except in cases of unequivocal necessity.

Ability to influence reaction speed when driving or operating machinery

No effect.

Method of Administration and Dosage

Fungosept® nail lacquer should be applied to affected nails once or twice a week.

The following recommendations should be carefully followed when applying the lacquer:

• Before the first application of Fungosept® nail lacquer, the nails should be thoroughly and carefully cleaned, taking care not to touch the surrounding skin, and the affected nail areas (particularly the nail surface) should be filed as meticulously as possible. The nail surface should be cleaned and degreased using a swab or wipe moistened with a nail polish remover.
• Using one of the reusable spatulas, apply the lacquer evenly over the entire surface of the affected nail. The reusable spatula should be cleaned each time when moving from one nail to another to avoid contamination of the lacquer. The spatula should be dipped into the lacquer and removed from the bottle without wiping off excess lacquer against the neck of the bottle.
• It is important to clean the reusable spatula with a swab or wipe moistened with a nail polish remover after each application, before reusing it on another nail, to prevent contamination of the lacquer.
• If the lacquer has been accidentally applied to the outer surface of the cap, it is important to clean it immediately using a swab or wipe moistened with a nail polish remover to avoid skin contact. The bottle should always be kept tightly closed.

Repeat all the above steps for each affected nail.

Cosmetic nail polish may be applied no sooner than 10 minutes after Fungosept® nail lacquer application. Treatment should be continued without interruption until complete nail renewal and full clinical and mycological healing of the affected areas.

The duration of treatment typically lasts 6 months for fingernails and 9 months for toenails (this primarily depends on the severity of the infection, its location, and the extent of nail involvement).

Special recommendations:

• Do not reuse files used for filing infected nails on healthy nails;
• Before each new application, if necessary, the affected nails should be filed and always cleaned with a nail polish remover to remove any residual lacquer;
• When working with organic solvents (e.g., white spirit, thinners), impermeable gloves should be worn to protect nails coated with Fungosept® nail lacquer.

Children

Due to lack of data, the use of Fungosept® nail lacquer is not recommended in patients under 18 years of age.

Overdose

No systemic signs of overdose are expected following topical application of Fungosept® nail lacquer. In case of accidental oral ingestion, appropriate symptomatic treatment should be administered.

Adverse Reactions

Isolated cases of adverse reactions are possible. Nail disorders such as nail discoloration and nail brittleness may occur. These reactions may also be caused by onychomycosis itself.

Skin and subcutaneous tissue disorders:
Rare (≥1/10,000, <1/1,000): nail disorders, nail discoloration, onychoclasis (nail fragility), onychorrhexis (brittle nails);
Very rare (<1/10,000): skin burning sensation;
Frequency not known (cannot be estimated from available data): erythema, pruritus, contact dermatitis, urticaria, blisters.

Immune system disorders:
Frequency not known: hypersensitivity (systemic allergic reaction).

Reporting suspected adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua

Shelf life: 3 years.

After first opening of the bottle, use within 6 months.

Storage conditions.

Store at temperatures not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

2.5 ml in a glass bottle with a plastic cap; 1 bottle with 10 application spatulas in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturers.

Farmaklar

(Bulk production, primary and secondary packaging, quality control)

Jadran-Galenski Laboratorij d.d.

(Responsible for batch release)

Manufacturers' addresses and locations of operations.

440 Avenue du Général de Gaulle, 14200 Herouville Saint Clair, France.

Svilno 20, 51000 Rijeka, Croatia.