Instructions for use Onihelp nail polish 50mg/ml 5% 5ml
Composition
active ingredient: amorolfine;
1 ml contains 55.74 mg of amorolfine hydrochloride, corresponding to 50.00 mg of amorolfine;
excipients: eudragit RL 100 (ammonium methacrylate copolymer type A), triacetin, n-butyl acetate, ethyl acetate, anhydrous ethanol.
Dosage form
Medical nail polish.
Main physicochemical properties: clear solution from colorless to pale yellow.
Pharmacotherapeutic group
Antifungal preparations for dermatological use. Other antifungal preparations for topical use.
ATX code D01A E16.
Pharmacological properties
Pharmacodynamics
Amorolfine is an antifungal drug for topical use. Amorolfine belongs to a new chemical class and has a fungicidal effect, which is due to changes in the cell membrane due to impaired sterol biosynthesis. The content of ergosterol is reduced, and at the same time atypical steric non-planar sterols accumulate.
Amorolfine has a broad antifungal spectrum of action.
It exhibits high activity (MIC < 2 μg/ml) in vitro against:
yeast fungi: Candida, Cryptococcus, Malassezia;
dermatophytes: Trichophyton, Microsporum, Epidermophyton;
mold fungi: Hendersonula, Alternaria, Scopulariopsis;
fungi from the Dematiaceae family: Cladosporium, Fonsecaea, Wangiella;
dimorphic fungi: Coccidioides, Histoplasma, Sporothrix.
Bacteria are not sensitive to amorolfine, with the exception of Actinomyces. Propionibacterium acnes are weakly sensitive to amorolfine.
Pharmacokinetics
After application of the solution to the nails, amorolfine penetrates the nail plate, which makes it possible to remove hard-to-reach fungi in the nail bed. Systemic absorption of the active substance is very low with this method of application.
With prolonged use of Onihelp nail polish, there are no signs of accumulation of the drug in the body.
Indication
Fungal nail lesions without matrix involvement (mild to moderate) caused by dermatophytes, yeasts and molds.
Contraindication
Hypersensitivity to the active substance or to other components of the drug.
Interaction with other medicinal products and other types of interactions
There are no studies on concomitant treatment with other drugs for external use.
The use of cosmetic nail polish or false nails should be limited during treatment.
Application features
Avoid getting nail polish in your eyes, ears, and mucous membranes.
During treatment with amorolfine, the use of cosmetic nail polish and false nails should be avoided.
When working with organic solutions, waterproof gloves should be worn to prevent removal of amorolfine.
Patients with peripheral circulatory system diseases, diabetes mellitus and immunosuppression, with nail dystrophy and a destroyed nail plate should consult a doctor before using the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
Amorolfine should not be used during pregnancy and/or breastfeeding.
Method of administration and doses
Nail polish should be applied to the affected fingernails or toenails once a week.
The varnish should be applied as follows:
Before the first application of the product, it is very important that the affected areas of the nail (especially the nail surface) are filed as thoroughly as possible using the nail file provided in the kit. The surface of the nail should be cleaned and degreased using an alcohol wipe (provided in the kit). Before re-application of the product, the affected area of the nail should be filed again, then the nail should be cleaned with an alcohol wipe to remove any varnish residue. Warning: Do not use files that have been used on affected nails on healthy nails. Apply the varnish to the entire surface of the affected nail using one of the applicators provided in the kit and allow the varnish to dry. After use, clean the applicator with the cleaning wipe that was previously used to clean the nail. Keep the bottle tightly closed.
When applying the product to the affected area of the nail, dip the applicator into the nail polish bottle without wiping the nail polish applicator against the neck of the bottle.
Warning: when working with organic solutions (solvents, white spirit), use waterproof gloves to keep Onihelp nail polish on your nails.
Do not interrupt the treatment until the nail has recovered and the affected areas have healed. The frequency and duration of treatment depend mainly on the intensity and location of the infection. Treatment usually lasts 6 months for fingernails and 9 to 12 months for toenails. It is recommended to repeat the course of treatment at intervals of approximately 3 months.
In case of athlete's foot, treatment should be carried out with an appropriate antifungal cream.
Children
The efficacy and safety of the drug in children have not been established. The drug should not be used in children.
Overdose
In case of accidental oral ingestion, seek medical attention. Treatment is symptomatic.
Adverse reactions
Rare cases of adverse reactions are possible. Nail lesions such as nail discoloration, nail brittleness may occur. Such reactions may also be associated with onychomycosis.
On the skin and subcutaneous tissue.
Rare (≥ 1/10,000, < 1/1,000) - nail damage, nail discoloration, onychoclasia (broken nail plates), onychorexis (fragility of nail plates).
Very rare (< 1/10,000) – burning sensation of the skin.
Unknown – redness, itching, contact dermatitis, urticaria, blisters.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep the bottle tightly closed, in an upright position, away from heat sources.
Keep out of reach of children.
Packaging
5 ml per bottle. One bottle together with 30 alcohol wipes, 60 cleaning files, 10 applicators in a cardboard box.
Vacation category
Without a prescription.
Producer
Belupo, pharmaceuticals and cosmetics, Inc.
Location of the manufacturer and its business address
Danica Street 5, 48000 Koprivnica, Croatia / Ulica Danica 5, 48 000 Koprivnica, Croatia.
