Onihelp^® (Lacquer) Instructions for Use

Marketing Authorization Holder

Belupo, Pharmaceuticals & Cosmetics d.d. (Croatia)

Manufactured By

Chanelle Medical (Ireland)

ATC Code

D01AE16 (Amorolfine)

Active Substance

Amorolfine (Rec.INN registered by WHO)

Dosage Form

Onihelp®

Nail lacquer 5%: bottle 2.5 ml or 5 ml in a set with applicators (10 pcs.), nail files (60 pcs.), alcohol wipes (30 pcs.)

Dosage Form, Packaging, and Composition

Nail lacquer transparent, from colorless to pale yellow.

Excipients : ethanol – 482.53 mg, ethyl acetate – 144.59 mg, Eudragit RL 100 (copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [2:0.2:1]) – 127.6 mg, n-butyl acetate – 50.08 mg, triacetin – 10.45 mg.

2.5 ml – dark glass bottles (1) in a set with applicators (10 pcs.), nail files (60 pcs.), alcohol wipes (30 pcs.) – cardboard packs.
5 ml – dark glass bottles (1) in a set with applicators (10 pcs.), nail files (60 pcs.), alcohol wipes (30 pcs.) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent for external use. It has fungistatic and fungicidal action.

It damages the fungal cell membrane, mainly by disrupting sterol synthesis. It reduces ergosterol content and causes the accumulation of abnormal non-planar stereoisomers of sterols.

It is active against yeasts of the genus Candida spp., Pityrosporum spp., Malassezia spp., Cryptococcus spp., dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton spp.), molds (Alternaria, Hendersonula, Scopulariopsis), fungi of Dematiaceae (Cladosporium, Fonsecaea, Wangiella), dimorphic fungi (Coccidioides, Histoplasma spp., Sporothrix) and actinomycetes.

Pharmacokinetics

When applied externally in appropriate dosage forms, systemic absorption is negligible.

Indications

• Treat onychomycosis caused by dermatophytes, yeasts, and molds.

Use only in cases where no more than 2/3 of the nail plate is affected by the infection.

• Employ for the prevention of fungal nail infections in patients at risk.

ICD codes

Dosage Regimen

Apply for external use only. Cleanse the affected nail, file down the damaged area, and degrease the surface with an alcohol wipe before each application.

Apply the lacquer once or twice weekly using the supplied applicator, ensuring complete coverage of the entire nail plate. Continue treatment until the nail has completely regrown, typically 6 months for fingernails and 9 to 12 months for toenails.

Adverse Reactions

Adverse reactions are typically localized to the site of application. These may include a burning sensation, localized skin hyperemia (redness), and itching.

In rare instances, nail discoloration, nail pain, or periungual eczema may occur. Discontinuation of therapy is usually sufficient for the resolution of these effects.

Drug Interactions

No specific drug interactions with systemically administered medicinal products are known, due to negligible systemic absorption.

Avoid concurrent use of other topical nail preparations, as they may alter the film-forming properties and efficacy of the lacquer. Do not apply cosmetic nail polish or use artificial nails during treatment.

Contraindications

• Do not use in patients with a known hypersensitivity to amorolfine or to any of the excipients in the formulation.

Avoid use during the neonatal period and early childhood due to a lack of safety and efficacy data in this patient population.

• Contraindicated for use during pregnancy and the lactation period.

Overdose

Accidental ingestion is unlikely due to the small total volume and topical application method. If ingested, institute gastric lavage and administer activated charcoal if a large amount is consumed.

Systemic effects from topical over-application are not anticipated. In case of excessive local skin reactions, discontinue use and remove the lacquer with an organic solvent. Treatment should be symptomatic and supportive.

Use in Pregnancy and Lactation

Contraindicated: pregnancy, lactation period.

Pediatric Use

Contraindicated: neonatal period and early childhood.

Special Precautions

During treatment, it is not recommended to use cosmetic nail polish or artificial nails. When working with organic solvents, impermeable gloves should be worn. Nail files used to treat affected nails should not be used on healthy nails.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.