Oflomil 5% 2.5 ml

Oflomil instruction for use

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Composition

1 ml of the preparation contains:
Active substance:
Amorolfine hydrochloride, 55.70 mg
in terms of amorolfine 50.00 mg
Excipients:
Triacetin (glycerol triacetate) 10.50 mg
Methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.2: 1] (ammonium methacrylate copolymer (Type A) (Eudragit RL 100)) 125.00 mg
Ethyl acetate 150.00 mg
Butyl acetate 50.00 mg
Anhydrous ethanol to 1 ml
Description: clear liquid from colorless to light yellow color.

Pharmacological properties

Antifungal drug for external use. It has a fungistatic and fungicidal effect due to damage to the cytoplasmic membrane of the fungus through disruption of the biosynthesis of sterols. Reduces the content of ergosterol, accumulates the content of atypical steric non-planar sterols.
It has a wide spectrum of action. It is highly active against both the most common and rare pathogens of fungal nail infections:
Dermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton spp.
Yeast fungi: Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.)
Mold fungi: Alternaria spp., Scopulariopsis spp., Hendersonula spp.
Fungi from the family Dematiaceae: Cladosporium spp., Fonsecaea spp., Wangiella spp.
Dimorphic fungi: Coccidioides spp., Histoplasma spp., Sporothrix spp.

Pharmacokinetics

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

Indications for use

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

Contraindications

Hypersensitivity to amorolfine or any of the components of Oflomil.

Use during pregnancy and during breastfeeding

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

Dosage and administration

Outwardly. Apply to the affected nails of the fingers or toes 1-2 times a week as follows:
1. Before use, remove, if possible, the affected areas of the nail (especially from its surface) using the enclosed nail file.
2. Then clean and degrease the surface of the nail with the supplied swab moistened with alcohol.
Before each subsequent use of Oflomil, it is also necessary to treat the affected nails with a nail file and then remove the remaining nail polish layer with an alcohol swab.
3. Dip the spatula in the lacquer. The spatula should be removed from the bottle, without touching the neck, do not wash the excess nail polish on the neck of the bottle.
4. Using a spatula, apply the lacquer evenly on the entire surface of the affected nail.
Repeat the above procedure for each affected nail.
5. Close the bottle tightly immediately after use.
6. Allow the nail polish to dry for approximately 3 minutes.
7. Wipe the spatula with the swab used to clean the nail, while avoiding contact of the treated nails and the tampon. Dispose of the used tampon.
Applying decorative nail polish is possible no earlier than 10 minutes after the application of the nail polish Oflomil nail polish.
At repeated use of nail polish Oflomil nail polish. It is necessary to carefully remove the remaining decorative lacquer from the nails, then with the help of the attached nail files, treat the affected nails and remove the remaining nail polish layer with alcohol tampons. Wash your hands thoroughly after the procedure. If the nail polish was applied to the nails on the hands, wait until it is completely dry.
After the nail polish has dried, regular washing of the hands and feet with soap is allowed.
Treatment should be continued continuously until the nail is regenerated and the affected area is completely cured.
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. In the absence of signs of improvement after 3 months, it is recommended to consult a doctor.

Use in children

Clinical data on the use of Oflomil in pediatric patients are not available, so do not assign it to children.

Side effects of Oflomil

With the use of the drug Oflomil nail polish undesirable reactions are rare. Nail damage such as discoloration, destruction of nail plates, brittle nails, can be the result of fungal nail infections.

Overdose

Oflomil nail polish is a drug for external use with little systemic absorption and overdose is unlikely.
If you accidentally take Oflomil inside, you must clear the stomach and immediately consult a doctor.

Interaction with other drugs

Not installed.

Special instructions for Oflomil

    Files used to treat affected nails should not be used to process healthy nails;
    Persons working with organic solvents should wear impermeable gloves to protect varnished nails;
    During treatment, avoid using false artificial nails;
    The drug contains ethanol, so too frequent or incorrect application can lead to irritation or dryness of the skin around the nail;
    The swab contains a flammable substance.
Avoid getting Oflomil in the eyes, ears and mucous membranes. If nail polish gets into your eyes, rinse immediately with water. Patients with conditions predisposing to the development of fungal nail infections (impaired peripheral circulation, diabetes, immunodeficiency), 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 subject to destruction or fungal damage, you should also consult a doctor for the appointment of concomitant oral therapy.

Impact on the management of vehicles and mechanisms

Does not affect the ability to drive vehicles and mechanisms.
Shelf life - 2 years. Do not use the drug after the expiration date.

Storage conditions

Store in a dark place at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of the reach of children.
Release form - Nail polish 5%.
On 2.5 ml in a bottle from dark glass with a stopper from LDPE and the screw-on cap. On 1 bottle together with the application instruction, 12 sachets with the clearing tampons packed into a cardboard pack, 10 spatulas from LDPE fixed in a row and fixed in a frame, 12 nail files are placed in a cardboard pack.

Terms of sell

To buy Oflomil the prescription is not required.