Amorolfine-inteli

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT AMOROLFINE-INTELI

Composition:

Active substance: amorolfine hydrochloride;

1 ml of the product contains 50 mg of amorolfine hydrochloride in the form of amorolfine;

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

Pharmaceutical form. Therapeutic nail lacquer.

Main physico-chemical properties: clear solution ranging from colorless to pale yellow.

Pharmacotherapeutic group.

Antifungal agents for dermatological use. Other topical antifungal agents.

ATC code D01AE16.

Pharmacological properties.

Pharmacodynamics.

Amorolfine-Intelii, 50 mg/mL nail lacquer for therapeutic use, is an antifungal agent intended for topical application. 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 ergosterol content decreases, while atypical non-planar sterol intermediates accumulate simultaneously.

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

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

Bacteria, except for actinomycetes, are insensitive to amorolfine.

Pharmacokinetics.

From the nail lacquer, amorolfine penetrates into the nail plate and diffuses through it, thus being able to eradicate fungi located in the nail bed that are otherwise difficult to reach. Systemic absorption of the active substance following this mode of application is very low.

There is no evidence of drug accumulation in the body following prolonged use of Amorolfine-Intelii 50 mg/mL therapeutic nail lacquer.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

During treatment, avoid applying cosmetic nail polish and using artificial nails.

Special precautions for use

Avoid contact of the lacquer with eyes, ears, and mucous membranes.

Patients with underlying conditions that predispose them to fungal nail infections (such as peripheral circulatory disorders, diabetes mellitus, or immunosuppression) should consult a physician.

Patients with nail dystrophy or severely damaged nail plates should consult a physician.

Use during pregnancy or breastfeeding

Reproductive toxicity studies in laboratory animals have not shown any evidence of teratogenicity; however, embryotoxic effects were observed following oral administration of the drug at high doses. Systemic absorption of amorolfine during and after topical application is very low, therefore the risk to the human fetus is considered negligible. Nevertheless, due to the lack of adequate experience with use in humans, application of Amorolfine-Intel, 50 mg/mL nail lacquer for treatment, should be avoided during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery

No effect.

Method of Administration and Dosage

Adults, including elderly patients

Apply the nail lacquer once weekly to affected fingernails or toenails.

Patients should apply the lacquer as described below.

Before the first application of Amorolfine-Intel, it is essential to thoroughly file the affected nail areas (particularly the nail surface) using the nail file provided with the product. Then, the nail surface should be cleaned and degreased using the wipe provided. Before each subsequent application of Amorolfine-Intel 50 mg/mL nail lacquer, the affected nails should again be filed and cleaned with the wipe to remove any residual lacquer.

Note: Do not use the nail file that has been used on infected nails to file healthy nails.

Using one of the reusable spatulas provided, apply the lacquer to the entire surface of the affected nail and leave it to dry. After use, clean the spatula with the same wipe used for cleaning the nails. The bottle must be kept tightly closed.

When applying the lacquer to each affected nail, the spatula should be dipped into the lacquer bottle. When removing the spatula, do not wipe off excess lacquer against the neck of the bottle.

Note: When working with organic solvents (diluents, white spirit), wear impermeable gloves to protect nails treated with Amorolfine-Intel medicinal nail lacquer.

Treatment should continue uninterrupted until nail regrowth and complete healing of affected areas. The duration of treatment depends on the severity of the infection and its location. Generally, treatment lasts 6 months for fingernails and 9 to 12 months for toenails. Therapy should be reviewed approximately once every 3 months.

Concomitant athlete's foot (dermatophytosis) should be treated with an appropriate antifungal cream.

Children

The safety and efficacy of the product in children (under 18 years of age) have not been established.

Overdose

Amorolfine-Intel is intended for topical use only. In case of accidental ingestion, appropriate gastric evacuation procedures should be performed.

Side effects.

Adverse reactions to the drug are rare. Nail disorders (e.g. nail discoloration, brittleness, fragile nails) are possible. These reactions may also be caused by the underlying onychomycosis itself.

Skin and subcutaneous tissue disorders:
Rare (≥ 1/10000, < 1/1000): nail disorders, nail discoloration, onychoclasis (nail brittleness), onychorrhexis (fragile nails);
Very rare (< 1/10000): skin burning sensation.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C, in a place protected from light.

Keep out of reach of children.

Protect from exposure to high temperatures. After use, store the bottle in an upright position, tightly closed.

Packaging.

2.5 ml in a bottle. One bottle with nail files, cleansing wipes, and applicators for lacquer application, all contained in a cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

Chanel Medical Limited Company.

Manufacturer's address and place of business.

Dublin Road, Lochrea, H62 HCH90, Ireland.