Oflomil Lak (Lacquer) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

Contact Information

GLENMARK IMPEX LLC (Russia)

ATC Code

D01AE16 (Amorolfine)

Active Substance

Amorolfine (Rec.INN registered by WHO)

Dosage Form

Oflomil Lak

Medicinal nail lacquer 5%: bottle 2.5 ml or 5 ml in a set with sachets of cleansing tampons (12 pcs.), spatulas (10 pcs.), nail files (12 pcs.)

Dosage Form, Packaging, and Composition

Medicinal nail lacquer in the form of a transparent liquid from colorless to light yellow.

Excipients: triacetin (glycerol triacetate) – 10.5 mg, copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [2:0.2:1] (ammonium methacrylate copolymer (Type A) (Eudragit RL100)) – 125 mg, ethyl acetate – 150 mg, butyl acetate – 50 mg, anhydrous ethanol – up to 1 ml.

2.5 ml – dark glass bottles (1) in a set with sachets of cleansing tampons (12 pcs. in a cardboard pack); LDPE spatulas (10 pcs., fixed in a row and secured in a frame); nail files (12 pcs. in a plastic bag) – cardboard packs.
5 ml – dark glass bottles (1) in a set with sachets of cleansing tampons (12 pcs. in a cardboard pack); LDPE spatulas (10 pcs., fixed in a row and secured in a frame); nail files (12 pcs. in a plastic bag) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agents used in dermatology; external antifungal agents; other external antifungal agents

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. It reduces the content of ergosterol and increases the content of atypical steric non-planar sterols.

It has a broad spectrum of action. 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 Dematiaceae family – 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). The 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

The drug is for external use.

Apply to the affected fingernails or toenails 1-2 times a week as follows

1. Before applying the drug, remove the affected parts of the nail (especially on 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.

1. Dip the spatula into the lacquer. The spatula should be removed from the bottle without touching its neck; excess lacquer should not be wiped off on the bottle neck.
2. Using the spatula, apply the lacquer in an even layer over the entire surface of the affected nail.

Repeat the above procedure for each affected nail.

1. Close the bottle tightly immediately after use.
2. Allow the lacquer to dry for approximately 3 minutes.
3. Wipe the spatula with the tampon used to clean the nail, avoiding contact between the treated nails and the tampon. Discard the used tampon.

Application of decorative nail polish is possible no earlier than 10 minutes after applying Oflomil Lak nail lacquer.

When reapplying Oflomil Lak nail lacquer, it is necessary to carefully remove any 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 fingernails, you must first wait for it to dry completely.

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

Treatment should be continued continuously 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 nail plates, the first signs of improvement may only become noticeable 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.

Use in children

Clinical data on the use of the drug in pediatric patients are not available, therefore it should not be prescribed to children.

Adverse Reactions

When using Oflomil Lak, adverse reactions are rarely observed. Such nail damages as discoloration, destruction of nail plates, brittleness of nails may be a consequence of fungal nail infection.

All adverse reactions noted with the use of Oflomil Lak are presented in the table below in accordance with the accepted classification by organ systems and frequency of occurrence: 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).

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

Contraindications

• Hypersensitivity to amorolfine or any component of the drug.

Use in Pregnancy and Lactation

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

Clinical data on the use of the drug in pediatric patients are not available, therefore it should not be prescribed to children.

Special Precautions

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

The tampon contains a flammable substance.

Avoid getting the drug into the eyes, ears, and mucous membranes. If the lacquer gets into the eyes, rinse them immediately with water.

Patients with conditions predisposing to the development of fungal nail infections (peripheral circulatory disorders, diabetes mellitus, immunodeficiencies), as well as patients with nail dystrophy or 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 fungus, it is also necessary to consult a doctor for the appointment of concomitant oral therapy.

Effect on the ability to drive vehicles and mechanisms

Does not affect the ability to drive vehicles and mechanisms.

Overdose

Oflomil Lak is a drug for external use with negligible systemic absorption and overdose is unlikely.

In case of accidental ingestion of the drug, gastric lavage should be performed and a doctor should be consulted immediately.

Drug Interactions

Not established.

Storage Conditions

The drug should be stored out of the reach of children, in a light-protected place at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date.

Dispensing Status

The drug is 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.