Oflomil nail polish 5%, 2.5 ml

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

• prevention of fungal infections of the nails.

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

1. Before using the drug, remove, if possible, the affected areas of the nail (especially on its surface) using the supplied nail file.

2. Then clean and degrease the surface of the nail with the supplied swab moistened with alcohol. Treatment of nails with a nail file and a swab with alcohol must be carried out before each use of the drug.

3. Dip the spatula into the varnish. The spatula should be removed from the bottle without touching its neck; you should not wipe off excess varnish on the neck of the bottle.

4. Apply the varnish to the entire surface of the affected nail using a spatula.

Repeat the above procedure for each affected nail.

5. Close the bottle tightly immediately after use.

6. Let the varnish dry for about 3 minutes.

7. Wipe the spatula with a used swab. Avoid contact between treated nails and the swab. Discard the used swab.

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 9Ц12 months for toenails.

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

Medicinal nail varnish in the form of a clear liquid from colorless to light yellow.

1 ml

amorolfine hydrochloride 55.7 mg,

which corresponds to the content of amorolfine 50 mg

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

Hypersensitivity to the components of the drug.

pharmachologic effect

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

Possesses a wide spectrum of action. It is highly active against both the most common and rare pathogens of fungal infections of the nails: dermatophytes - Trichophyton spp., Microsporum spp., Epidermophyton spp .; yeast fungi - Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.); molds - Alternaria spp., Scopulariopsis spp., Hendersonula spp .; fungi from the Dematiaceae family - Cladosporium spp., Fonsecaea spp., Wangiella spp .; dimorphic fungi - Coccidioides spp., Histoplasma spp., Sporothrix spp.

Pharmacokinetics

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

Application during pregnancy and lactation

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

Application in children

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

special instructions

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

Persons handling organic solvents must wear impervious gloves to protect varnished nails.

The use of false artificial nails should be avoided during treatment.

The product contains ethanol, so applying it too often or inappropriately can lead to irritation or dryness of the skin around the nail.

The swab contains a highly flammable substance.

Avoid getting the drug in the eyes, ears and mucous membranes. In case of contact with eyes, rinse 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 a destroyed nail plate, psoriasis or other chronic skin diseases should consult a doctor.

If more than 2/3 of the nail plate is affected by destruction or fungal infection, you should also consult a doctor for the appointment of concomitant oral therapy.

Influence on the ability to drive vehicles and mechanisms

Does not affect the ability to drive vehicles and mechanisms.

Overdose

Oflomil Lac is a drug for external use with insignificant systemic absorption and overdose is unlikely.

In case of accidental ingestion of the drug, it is necessary to rinse the stomach and immediately consult a doctor.