Loceryl^® (Lacquer) Instructions for Use

Marketing Authorization Holder

Galderma, SA (Switzerland)

Manufactured By

Laboratoires Galderma (France)

Contact Information

GALDERMA SA (Switzerland)

ATC Code

D01AE16 (Amorolfine)

Active Substance

Amorolfine (Rec.INN registered by WHO)

Dosage Form

Loceryl®

Medicinal nail lacquer 5%: bottle 2.5 ml or 5 ml with applicator, tampons (30 pcs.), and nail files (30 pcs.)

Dosage Form, Packaging, and Composition

Medicinal nail lacquer 5% is a transparent, colorless or almost colorless liquid.

Excipients: methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2:0.2:1] – 143 mg, triacetin – 12 mg, butyl acetate – 57 mg, ethyl acetate – 172 mg, absolute ethanol – 552 mg.

2.5 ml – dark glass bottles (1) with a plastic screw cap with a built-in applicator and a polymer insert to prevent the preparation from drying out, together with instructions for use, 30 tampons soaked in isopropyl alcohol (in hermetically sealed sachets made of laminated aluminum foil) and 30 nail files – cardboard boxes with first opening control.
5 ml – dark glass bottles (1) with a plastic screw cap with a built-in applicator and a polymer insert to prevent the preparation from drying out, together with instructions for use, 30 tampons soaked in isopropyl alcohol (in hermetically sealed sachets made of laminated aluminum foil) and 30 nail files – cardboard boxes with first opening control.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal drug for external use. It has a fungistatic and fungicidal effect due to damage to the fungal cytoplasmic membrane by disrupting sterol biosynthesis. The ergosterol content decreases, and the content of atypical steric non-planar sterols accumulates.

It has a broad spectrum of antifungal activity. Highly active against both the most common and rare causative agents of fungal nail infections

• Dermatophytes – Trichophyton spp., Microsporum spp., Epidermophyton spp.;
• Yeasts – Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.);
• Molds – Alternaria spp., Scopulariopsis spp., Hendersonula spp.;
• Fungi of the family Dematiaceae – Cladosporium spp., Fonsecaea spp., Wangiella spp.;
• Dimorphic fungi – Coccidioides spp., Histoplasma spp., Sporothrix spp.

Pharmacokinetics

When applied to the nails, it penetrates the nail plate and further into the nail bed (almost completely within the first 24 hours). An effective concentration is maintained in the affected nail plate for 7-10 days after the first application. Systemic absorption is negligible: the concentration in plasma is below the sensitivity limit of detection methods (less than 0.5 ng/ml).

Indications

• Treatment of fungal nail infections caused by dermatophytes, yeasts, and molds;
• Prevention of fungal nail infections.

ICD codes

Dosage Regimen

For external use. Apply to the affected fingernails or toenails 1-2 times a week as follows

1. Before using the drug, remove the affected parts of the nail (especially from its surface) as much as possible using the provided nail file.

2. Then clean and degrease the nail surface with the provided alcohol-soaked tampon.

Before each subsequent application of the drug, it is also necessary to treat the affected nails with a file and then remove the remaining layer of lacquer with an alcohol tampon.

3. Dip the applicator built into the cap into the bottle with the lacquer and then carefully remove it without wiping off the excess lacquer on the neck of the bottle.

4. Using the applicator, apply the lacquer in an even layer over the entire surface of the affected nail.

Repeat the above procedure for each affected nail.

5. Let the lacquer dry for 3 minutes.

6. Wipe the applicator with the tampon used to clean the nail, avoiding contact between the treated nails and the tampon. Close the bottle tightly immediately after the procedure. Discard the used tampon.

Application of decorative nail polish is possible no earlier than 10 minutes after applying Loceryl^® nail lacquer.

When reapplying Loceryl^® lacquer, it is necessary to carefully remove the remaining decorative polish from the nails, then use the provided files to treat the affected areas of the nails and remove the remaining layer of lacquer with alcohol tampons.

After the procedure, wash your hands thoroughly. If the lacquer was applied to the fingernails, wait for it to dry completely first.

After the lacquer has dried, regular washing of hands and feet with soap is allowed.

Treatment should be continued until the nail regenerates and the affected area is completely healed.

The average duration of treatment is 6 months for fingernails and 9-12 months for toenails.

Due to the slow growth of the nail plates, the first signs of improvement may become noticeable only after 2-3 months of using the drug. If there are no signs of improvement after 3 months, it is recommended to consult a doctor.

Adverse Reactions

Adverse reactions when using Loceryl^® are rare. Such nail damages as discoloration, destruction of nail plates, brittleness of nails, may be a consequence of fungal nail infection.

All adverse reactions noted when using Loceryl^® are presented in the table below according to the following frequency categories: very common (≥1/10), common (≥1/100-<1/10), uncommon (≥1/1000-<1/100), rare (≥1/10000-<1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

* Data from post-marketing surveillance.

If any of the side effects mentioned in the instructions get worse, or you notice any other side effects not listed in the instructions, you should immediately inform your doctor.

Contraindications

• Hypersensitivity to amorolfine or any component of the drug.

Use in Pregnancy and Lactation

Data on the use of amorolfine during pregnancy and/or breastfeeding are limited. Animal studies have shown reproductive toxicity when the drug was administered orally at high doses. Due to the extremely low systemic exposure of amorolfine when applied topically in the form of nail lacquer, the degree of risk to the fetus is negligible. It is not known whether Amorolfine passes into breast milk.

Due to limited data on the use of amorolfine in pregnant and breastfeeding women, the use of the drug during pregnancy and breastfeeding is not recommended.

Pediatric Use

There are no clinical data on the use of the drug in pediatric patients, therefore Loceryl^® should not be prescribed to children.

Special Precautions

Files used to treat affected nails should not be used to treat healthy nails.

Persons working with organic solvents should wear impermeable gloves to protect nails coated with the lacquer.

During treatment, the use of artificial overlay nails should be avoided.

The drug contains ethanol, so too frequent or improper application may lead to irritation or dryness of the skin around the nail.

Loceryl^® lacquer should not be applied to the skin around the nail.

The tampon contains a flammable substance.

Avoid getting the lacquer into the eyes, ears, and mucous membranes. If the lacquer gets into the eyes, they should be rinsed immediately with water.

Patients with conditions predisposing to the development of fungal nail infections (impaired peripheral circulation, diabetes mellitus, immunodeficiencies), as well as patients with nail dystrophy or a destroyed nail plate, psoriasis or other chronic skin diseases should consult a doctor.

If more than 2/3 of the nail plate is destroyed or affected by a fungal infection, it is also necessary to consult a doctor for the appointment of concomitant oral therapy.

If systemic and local allergic reactions occur, the use of Loceryl^® lacquer should be discontinued immediately and a doctor should be consulted. Using nail polish remover, remove the drug from the nails. The drug should not be reapplied.

Use in children

There are no clinical data on the use of the drug in pediatric patients, therefore it should not be prescribed to children.

Effect on ability to drive vehicles, operate machinery

The drug does not affect the ability to drive vehicles and operate machinery.

Overdose

With topical application of the drug, the development of systemic signs of overdose is not expected.

Treatment in case of accidental ingestion of the drug, appropriate symptomatic therapy should be carried out.

Drug Interactions

Not established.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

Available without a prescription.

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.