Exoderil® nail lacquer

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EXODERIL® NAIL LACQUER (EXODERIL® NAIL LACQUER)

Composition:

Active substance: amorolfine;

1 ml of solution contains 55.7 mg of amorolfine hydrochloride, equivalent to 50 mg of amorolfine

(5% amorolfine solution);

Excipients: absolute ethanol, ammonium methacrylate copolymer (type A), ethyl acetate, butyl acetate, triacetin.

Pharmaceutical form. Nail treatment lacquer.

Main physicochemical properties: colorless or almost colorless transparent solution.

Pharmacotherapeutic group.

Antifungal agents for dermatological use. Other topically used antifungal agents. ATC code D01AE16.

Pharmacological properties.

Pharmacodynamics.

Exoderil® Nail Lacquer, 50 mg/mL, is an antifungal agent 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. Ergosterol content 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 (black) fungi: Hendersonula, Alternaria, Cladosporium;

species with lower sensitivity: Aspergillus, Fusarium, Mucorales.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interactions.

Currently available information does not indicate the presence of clinically significant interactions.

Special precautions for use

Exoderil® Nail Lacquer should not be applied to the skin around the nail. Care should be taken to avoid contact of the lacquer with the eyes, ears, and mucous membranes.

Exoderil® Nail Lacquer should be used with caution in patients with conditions that predispose them to nail damage (such as peripheral circulation disorders, diabetes mellitus, and immunosuppression), as well as in patients with nail dystrophy or severely damaged nails (more than two-thirds of the nail plate destroyed). In such cases, systemic treatment should be considered.

Do not use artificial nails during treatment with Exoderil® Nail Lacquer.

When working with organic solvents, impermeable gloves should be worn to prevent dissolution of the lacquer. Cosmetic nail polish may be applied no sooner than 10 minutes after application of Exoderil® Nail Lacquer. Before reapplying Exoderil® Nail Lacquer, cosmetic nail polish must be carefully removed.

After using this medicinal product, systemic or local allergic reactions may occur. In such cases, the use of the lacquer should be discontinued immediately and medical advice sought. The product should be thoroughly removed using a nail polish remover. The medicinal product must not be reused.

This medicinal product contains 0.4823 g of alcohol (ethanol) per ml of therapeutic nail lacquer. This may cause a burning sensation on damaged skin. Ethanol is a flammable substance; therefore, this product should not be used near open flames, lit cigarettes, or certain devices (e.g., hair dryers).

Use during pregnancy or breastfeeding

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

It is unknown whether amorolfine is excreted in human breast milk.

Exoderil® Nail Lacquer should not be used during pregnancy or breastfeeding unless clearly necessary.

Ability to influence reaction speed when driving or operating machinery

No effect.

Method of Administration and Dosage

Apply Exoderil® Nail Lacquer to affected nails once or twice weekly.

The lacquer should be applied carefully, strictly following these recommendations:

• Before the first application, thoroughly and carefully clean the nails, taking care not to touch the surrounding skin. Affected nail areas (particularly the surface) should be filed as meticulously as possible using the special file provided in the package. The nail surface should then be cleaned and degreased using a swab moistened with nail polish remover.
• Using one of the reusable spatulas provided in the package, apply the lacquer evenly over the entire surface of the affected nail. The reusable spatula must 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 nail polish remover after each application and before reusing it on another nail to prevent contamination of the lacquer.
• If during application the lacquer comes into contact with the outer surface of the cap, it is essential to clean it with a swab or wipe moistened with 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 applying Exoderil® Nail Lacquer.

Treatment should continue uninterrupted until complete nail regeneration and full clinical and mycological healing of the affected areas are achieved.

The duration of treatment is generally 6 months for fingernails and 9 months for toenails (depending primarily on the severity of the infection, its location, and the extent of nail involvement).

Special recommendations:

− Do not reuse files that have been used to file infected nails for filing healthy nails.

− Before each new application, if necessary, the affected nails should be filed and, in all cases, cleaned with a nail polish remover to remove any residual lacquer.

− When working with organic solvents (e.g., white spirit, paint thinners, etc.), impermeable gloves should be worn to protect nails coated with Exoderil® Nail Lacquer.

Children

Due to lack of data, Exoderil® Nail Lacquer is not recommended for patients under 18 years of age.

Overdose

Isolated cases of adverse reactions may occur. Nail disorders such as nail discoloration and nail brittleness may be observed. These reactions may also be associated with onychomycosis.

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

Side effects.

* Adverse reactions reported since the drug was marketed.

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the drug. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

After opening the bottle – 6 months.

Storage conditions.

This medicinal product does not require any special storage temperature conditions. Keep the bottle tightly closed. Store away from heat sources and open flames. Keep out of reach of children.

Packaging.

2.5 ml in a bottle. One bottle with 10 spatulas, 30 cleansing swabs, and 30 nail files in a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

Lek Pharmaceuticals d.d.

Manufacturer's address and place of business.

Verovskova 57, Ljubljana 1526, Slovenia.