Onihelp

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ONYHELP

Composition:

Active substance: amorolfine;

1 ml contains 55.74 mg of amorolfine hydrochloride, equivalent to 50.00 mg of amorolfine;

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

Pharmaceutical form. Therapeutic nail lacquer.

Main physicochemical properties: clear solution, colorless to pale yellow.

Pharmacotherapeutic group. Antifungal agents for dermatological use. Other antifungals for local use.

ATC code D01A E16.

Pharmacological properties.

Pharmacodynamics.

Onihelp, 50 mg/ml nail lacquer, is an antifungal agent for topical use. The active substance of the medicinal product, amorolfine, belongs to a new class of chemical compounds; its fungicidal action is based on altering the fungal cell membrane, primarily due to its effect on sterol biosynthesis. The content of ergosterol decreases, while atypical non-planar sterol intermediates accumulate, leading to morphological changes in cellular membranes and organelles, and ultimately to 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;

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

species with low sensitivity: Aspergillus, Fusarium, Mucorales.

Pharmacokinetics.

Amorolfine, the active ingredient of the medicinal product, penetrates into the nail plate and diffuses through it, thereby being able to eradicate fungi located in the nail bed, which are difficult to reach. Systemic absorption of amorolfine 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.

Interaction with other medicinal products and other forms of interaction.

There are no studies regarding concomitant use with other topical medicinal products.

The use of cosmetic nail polish or artificial nails should be avoided during treatment.

Instructions for use.

Avoid contact of the lacquer with eyes, ears, and mucous membranes.

Onyhelp should not be applied to the nail bed, as this may cause local effects such as contact dermatitis.

Due to lack of clinical experience, children should not use the antifungal nail lacquer containing 50 mg/mL of amorolfine.

During treatment with amorolfine, avoid using cosmetic nail varnish and artificial nails.

When working with organic solvents, use waterproof gloves to prevent removal of amorolfine.

Systemic or local allergic reactions may occur after application of this medicinal product. If this occurs, discontinue use immediately and consult a physician. Carefully remove the medicinal product using nail polish remover. Do not reapply the medicinal product.

Alcohol content

Onyhelp, medicinal nail lacquer, contains 482.53 mg of alcohol (ethanol) per 1 mL of solution (55.40% w/w). This may cause a burning sensation on damaged skin. Ethanol is a highly flammable substance; therefore, the lacquer should not be used near open flames, lit cigarettes, or certain devices (such as hair dryers).

Use during pregnancy or breastfeeding.

Experience with the use of amorolfine during pregnancy and breastfeeding is limited. Only a few cases of topical application of amorolfine in pregnant women have been reported in the post-marketing period, so the potential risk is unknown. Animal studies have shown reproductive toxicity at high oral doses.

It is unknown whether amorolfine is excreted in breast milk.

Amorolfine should not be used during pregnancy and breastfeeding, except when clearly necessary.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Method of Administration and Dosage

The nail lacquer should be applied to the affected fingernails or toenails once weekly.

The lacquer should be applied as follows:

1. Before the first application of the medicinal product, it is very important to thoroughly file the affected nail areas (particularly the nail surface) as carefully as possible using the nail file provided in the package. The nail surface should be cleaned and degreased using an alcohol swab (provided in the package). Before each subsequent application, the affected nail area should be filed again, and then the nail should be cleaned with an alcohol swab to remove any residual lacquer.

Warning: Do not use nail files that have been used on infected nails for healthy nails.

2. Using one of the applicators provided in the package, apply the lacquer to the entire surface of the affected nail and allow the lacquer to dry. After use, clean the applicator with the cleaning wipe previously used to clean the nail. Keep the bottle tightly closed.

To apply the medicinal product to the affected nail area, immerse the applicator into the bottle containing the lacquer, without wiping the lacquer-coated applicator against the neck of the bottle.

The required duration of treatment depends on the severity and location of the infection. Typically, treatment lasts 6 months for fingernails and from 9 to 12 months for toenails.

Elderly Patients

There are no specific dosage recommendations for elderly patients.

Children

There are no specific dosage recommendations for children due to the lack of available clinical experience.

Overdose

No cases of overdose have been observed, as the medicinal product is applied topically.

In case of accidental oral ingestion, seek medical advice. Treatment is symptomatic.

Adverse reactions

Adverse reactions during the use of the medicinal product are observed rarely. Nail disorders may occur (e.g., nail discoloration, broken nail plates, brittle nails). Such reactions may also be associated with onychomycosis.

The adverse reactions of the medicinal product, listed below, are classified by organ system classes and frequency. Frequency is defined according to the following categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).

* Post-marketing experience.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the use of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C.

Keep the bottle tightly closed, in an upright position, away from sources of heat.

Keep out of reach of children.

Packaging.

2.5 ml or 5 ml in a bottle together with alcohol wipes, nail files for cleaning, and applicators for lacquer application in a cardboard box.

Availability (prescription status). Over-the-counter.

Manufacturer.

Belupo, pharmaceuticals and cosmetics, Inc.

Manufacturer's address and location of operations.

Ulica Danica 5, 48 000 Koprivnica, Croatia.