AMODERM NEO

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT AMODERM NEO (AMODERM NEO)

Composition:

Active substance: amorolfine;

1 ml contains: amorolfine hydrochloride equivalent to 50 mg of amorolfine;

Excipients: ammonium methacrylate copolymer (type A), triacetin,
n-butyl acetate, ethyl acetate, anhydrous ethanol.

Pharmaceutical form. Therapeutic nail lacquer.

Main physicochemical properties: transparent solution, colorless to light yellow.

Pharmacotherapeutic group.
Antifungal agents for dermatological use. Other topical antifungal agents. ATC code D01AE16.

Pharmacological properties.

Pharmacodynamics.

An antifungal agent for topical use. Amorolfine belongs to a new class of chemical compounds; its fungicidal action is based on altering the fungal cell membrane, primarily through affecting sterol biosynthesis. The content of ergosterol decreases, while atypical non-planar sterols accumulate simultaneously.

Amorolfine is a broad-spectrum antifungal agent. It is highly active (MIC < 2 mcg/mL) in vitro against:

• dermatophytes Trichophyton, Microsporum, Epidermophyton;
• yeasts Candida, Cryptococcus, Malassezia;
• molds Hendersonula, Alternaria, Scopulariopsis, Scytalidium, Aspergillus;
• fungi of the family Dematiaceae: Cladosporium, Fonsecaea, Wangiella;
• dimorphic fungi Coccidioides, Histoplasma, Sporothrix.

Bacteria, with the exception of actinomycetes, are insensitive to amorolfine.

Pharmacokinetics.

Amorolfine contained in the nail lacquer penetrates into the nail plate and diffuses through it, thereby being able to eradicate fungi located in the nail bed that are difficult to reach. Systemic absorption of the active substance after such application is very low; its plasma concentration remains below the detection limit, even after one year of use.

Clinical characteristics.

Indications.

Treatment of onychomycosis without matrix involvement (mild to moderate degree), caused by dermatophytes, yeasts, and mold fungi.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

Current available data do not indicate the presence of clinically significant interactions.

Special precautions for use.

The nail lacquer should not be applied to the skin around the nail. Avoid contact of the lacquer with eyes, ears, and mucous membranes.

The lacquer should be used with caution in patients with conditions that predispose them to nail damage (peripheral circulation disorders, diabetes mellitus, and immunosuppression), as well as in patients with nail dystrophy or severely damaged nails (when more than two-thirds of the nail plate is destroyed). In such cases, systemic treatment should be considered.

Do not use artificial nails during application of the lacquer.

When working with organic solvents, impermeable gloves should be worn to prevent dissolution of the lacquer. Cosmetic nail polish may be applied no sooner than 10 minutes after application of the medicinal lacquer. Before reapplying the medicinal lacquer, cosmetic nail polish must be carefully removed.

Systemic or local allergic reactions may occur after using this medicinal product. In such cases, discontinue use of the lacquer immediately and consult a physician. The product should be thoroughly removed using a nail polish remover. The medicinal product must not be used again.

Use during pregnancy or breastfeeding.

There is limited data on the use of amorolfine during pregnancy or breastfeeding. Post-marketing reports include only a small number of pregnant women who used topical amorolfine, so the potential risk is unknown. Animal studies have shown reproductive toxicity when the drug was administered at high oral doses.

It is unknown whether amorolfine passes into breast milk.

Amoderm Neo should not be used during pregnancy or breastfeeding, except in cases where it is clearly necessary.

Ability to influence reaction rate while driving or operating machinery. No effect.

Method of administration and dosage.

Apply Amoderm Neo nail lacquer to affected nails once or twice a week.

The lacquer should be applied, strictly following the recommendations:

Nail cosmetic varnish should not be applied earlier than 10 minutes after application of Amoderm Neo varnish. Treatment should be continued without interruption until complete nail renewal and full clinical and mycological healing of affected areas.

The duration of treatment is generally 6 months for fingernails and 9 months for toenails (this depends primarily on the severity of infection, its location, and the extent of nail involvement).

Special recommendations:

• Files used for filing infected nails should not be reused for filing healthy nails.
• Prior to each new application, if necessary, the affected nails should be filed and in all cases cleaned with a nail polish remover to remove residual varnish.
• When working with organic solvents (such as white spirit, thinners, etc.), impermeable gloves should be worn to protect nails coated with Amoderm Neo varnish.

Children.

Due to lack of data, the use of Amoderm Neo varnish in patients under 18 years of age is not recommended.

Overdose.

Isolated cases of adverse reactions may occur. Possible nail disorders such as nail discoloration and nail brittleness. Such reactions may also be associated with onychomycosis.

No systemic signs of overdose are expected following topical application of the varnish. In case of accidental oral ingestion, appropriate symptomatic treatment should be administered.

Adverse reactions.

* Adverse reactions reported since the product was marketed.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 ºC, in a place inaccessible to children.

Keep the bottle tightly closed.

Packaging.

2.5 ml in a bottle together with applicators for lacquer application in a cardboard box; 2.5 ml in a bottle together with nail files, cleansing wipes, and applicators for lacquer application in a cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Chanel Medical Limited Company.

Manufacturer's address and place of business.

Dublin Road, Lochrea, H62 FH90, Ireland.

Marketing Authorization Holder.

PJSC "Kyivmedpreparat".

Address of the Marketing Authorization Holder.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.