AMOROLFINE BGR 5 % nail lacquer bottle/2,5ml+20 spatulas

Medicated nail lacquer.

Amorolfine hydrochloride.............................................................................................................................5,574 g

Quantity corresponding to amorolfine base................................................................................................5,000 g

For 100 ml.

Excipients:

First-line treatment of onychomycosis without matrix involvement.

Dosage

Apply AMOROLFINE BGR to the affected nails at a dosage of once or twice a week.

Method of administration

To apply the lacquer, carefully follow the recommendations below:

For packs without accessories :

A. Before the first application of AMOROLFINE BGR, thoroughly clean the nails and file the affected area of the nail (in particular the nail surface) as completely as possible with a nail file. Take care not to file the periungual skin.

B. Clean the nail surface and degrease it using a compress or cloth soaked in nail polish remover.

C. Apply the lacquer using one of the reusable spatulas over the entire affected nail. Clean the reusable spatula between each nail to avoid contamination of the lacquer. Do not wipe the spatula on the rim of the bottle.

D. It is important to thoroughly clean the spatula using a compress or cloth soaked in nail polish remover after each application, before reusing it on another nail, to avoid contamination of the lacquer.

E. If lacquer has been deposited on the outside of the cap during handling, it is important to clean it using a compress or cloth soaked in nail polish remover to avoid applying this lacquer to the skin.

F. Close the bottle tightly.

Repeat all of the above steps for each affected nail.

Cosmetic nail lacquers may be applied at least 10 minutes after application of AMOROLFINE BGR.

Treatment must be continued without interruption until complete regeneration of the nail and clinical and mycological cure of the affected areas.

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

Special instructions :

• do not reuse nail files on healthy nails;

• before each new application, file the affected nails if necessary and in all cases clean them with nail polish remover to remove residual lacquer;

• when handling organic solvents (white spirit, thinners…), it is necessary to wear waterproof gloves to protect the layer of AMOROLFINE BGR lacquer on the nails.

For packs with accessories :

A. Before the first application of AMOROLFINE BGR, carefully clean the nails and file the affected nail area (in particular the nail surface) using a nail file, as completely as possible. Take care not to file the periungual skin.

B. Clean the nail surface and degrease it using one of the cleaning wipes provided, in order to remove any residual varnish.

C. Apply the lacquer using one of the reusable spatulas over the entire affected nail. Clean the reusable spatula between each nail to avoid contamination of the lacquer. Do not wipe the spatula on the rim of the bottle.

D. It is important to thoroughly clean the spatula with one of the cleaning wipes provided after each application, before reusing it for another nail, in order to avoid contamination of the varnish.

E. If varnish has been deposited on the outside of the cap during handling, it is important to clean it with one of the cleaning wipes provided in order to avoid applying this varnish to the skin.

F. Close the bottle tightly.

Repeat all of the above steps for each affected nail.

Cosmetic nail lacquers may be applied at least 10 minutes after application of AMOROLFINE BGR.

Treatment must be continued without interruption until complete regeneration of the nail and clinical and mycological cure of the affected areas.

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

Special instructions :

• do not reuse nail files on healthy nails;

• before each new application, file the affected nails if necessary and, in all cases, clean them using the cleaning wipes to remove residual varnish;

• when handling organic solvents (white spirit, thinners…), it is necessary to wear waterproof gloves in order to protect the AMOROLFINE BGR varnish layer on the nails.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Avoid any contact of AMOROLFINE BGR with the eyes, ears or mucous membranes.

AMOROLFINE BGR should be used with caution in patients with conditions predisposing to nail disorders (peripheral circulatory disorders, diabetes, diseases of the immune system) as well as in patients presenting with nail dystrophy or severely damaged nails (more than two thirds of the nail plate is affected). In these cases, systemic treatment should be considered.

Do not use artificial nails during the use of AMOROLFINE BGR.

If organic solvents are handled, waterproof gloves must be worn, otherwise the varnish will be dissolved.

After application of AMOROLFINE BGR, a period of at least 10 minutes must be observed before applying cosmetic nail varnish. Before repeating the application of AMOROLFINE BGR, the cosmetic nail varnish must be carefully removed.

A systemic or local allergic reaction could possibly occur after use of this medicine. If this occurs, the medicine must be stopped immediately and a doctor must be consulted. Carefully remove the product using nail polish remover. The medicine must not be reused.

In the absence of data, the use of AMOROLFINE BGR is not recommended in patients under 18 years of age.

The data available to date do not suggest the existence of clinically significant interactions.

There are limited data on the use of amorolfine in pregnant and breastfeeding women. Only a small number of pregnancies exposed to topical amorolfine have been reported after marketing, so the potential risk is unknown.

Studies performed in animals have shown reproductive toxicity at high oral doses (see section Preclinical safety).

It is not known whether amorolfine is excreted in human milk.

AMOROLFINE BGR must not be used during pregnancy and breastfeeding, except in cases of real necessity.

System Organ Class	Frequency	Adverse effects
Immune system disorders	Frequency not known (cannot be estimated from the available data)	Hypersensitivity (systemic allergic reaction)*
Skin and subcutaneous tissue disorders	Rare (≥ 1/10 000, < 1/1 000)	Nail disorder, nail discolouration, brittle nails (onychoclasis), fragile nails (onychorrhexis)
	Very rare (< 1/10 000)	Sensation of skin burning
	Frequency not known (cannot be estimated from the available data)	Erythema, pruritus, contact dermatitis, urticaria, blister

* Adverse effects reported since marketing.

Reporting ofs suspected adverse effects

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

No systemic signs of overdose are expected following topical application of AMOROLFINE BGR.

In case of accidental ingestion, appropriate symptomatic measures should be taken.

Pharmacotherapeutic class: OTHER ANTIFUNGALS FOR TOPICAL USE, ATC code: D01AE16.

AMOROLFINE BGR is a topical antifungal. The active substance, amorolfine, a morpholine derivative, belongs to a new chemical class of antifungals. Its fungistatic and fungicidal effect is based on an alteration of the fungal cell membrane, mainly by targeting sterol biosynthesis.

The ergosterol content is reduced. An accumulation of atypical sterols leads to morphological changes in cell membranes and organelles that cause the death of the fungal cell.

Amorolfine has a broad antifungal spectrum. It is highly effective against the usual or occasional agents of onychomycoses:

• yeasts:

• Candida albicans and other Candida species.

• dermatophytes:

• Trichophyton rubrum, Trichophyton interdigitale and Trichophyton mentagrophytes, other Trichophyton species;
• Epidermophyton floccosum;
• Microsporum.

• moulds:

• Scopulariopsis.

• dematiaceous (black fungi):

• Hendersonula, Alternaria, Cladosporium.

• species with low sensitivity:

• Aspergillus, Fusarium, Mucorales.

Amorolfine in the form of a nail lacquer penetrates and diffuses through the nail plate and is able to eradicate fungi that are poorly accessible in the nail bed.

The general absorption of the active ingredient is negligible, with the plasma concentration remaining below the sensitivity threshold, even after one year of use.

In rats, amorolfine is not teratogenic and is not embryotoxic at the maximum oral dose tested of 40 and 80 mg/kg/day. However, signs of maternal toxicity (weight loss) were observed at doses of 40 and 80 mg/kg/day.

In rabbits, amorolfine is not teratogenic but has an embryotoxic effect at the maximum oral dose tested of 10 mg/kg/day. Maternal weight loss, reflecting maternal toxicity, was also observed at the dose of 10 mg/kg/day.

Due to the very low systemic absorption of amorolfine following application to the nail or skin, the potential risk of toxicity to the human fetus is negligible.

3 years.

This medicine does not require any particular storage precautions.

No special requirements.

Marketing authorisation (AMM)

CIP 3400927939730 (Fl/2,5ml+20 spatulas).

Price:

9,32 euros (Fl/2,5ml+20 spatulas).

Social Security reimbursement at 30% under the indications:

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree

Collection.