First line treatment of onychomycoses without involvement of the nail matrix (onychostroma).

Posology:
Apply LOCERYL on affected nails once or twice per week.
Method of administration:
To apply the lacquer, follow these recommendations carefully:

For packaging without accessories:
a) Before the first application of LOCERYL, carefully clean the nails and file the affected area of the nail (especially the nail surface) as completely as possible. Take care not to file the skin around the nail.
b) Clean the surface of the nail and remove any grease with a compress or tissue impregnated with nail varnish remover.
c) Apply the lacquer using one of the reusable spatulas over the whole of the affected nail. Clean the reusable spatula every time you move from one nail to another to avoid contaminating the lacquer. Do not wipe the spatula on the edge of the bottle.
d) It is important to clean the reusable spatula with a compress or tissue impregnated with nail varnish remover after
each application, before reusing it on another nail, to avoid contaminating the lacquer.
e) If lacquer has been deposited on the outside of the stopper during handling, it is important to clean it off using a compress or tissue impregnated with nail varnish remover, in order to avoid contact with the skin.
f) Recap the bottle tightly.
Repeat all of the above steps for each affected nail.

Cosmetic nail varnish may be applied at least 10 minutes after application of the LOCERYL lacquer. The treatment must be continued without interruption until complete regeneration of the nail and clinical and mycological healing of the affected areas.
The duration of treatment is generally 6 months for fingernails and 9 months for toenails (this depends mainly on the severity, the site of the infection and the height of the nail involvement).
Specific instructions:

• Do not re-use nail files for healthy nails.
• Before each new application, file the affected nails if necessary, and in all cases clean the nails with nail varnish remover to eliminate any residual lacquer.
• When handling organic solvents (white spirit, thinners, etc.), wear impermeable gloves to protect the LOCERYL lacquer layer on the nails.

For packaging with accessories:
a) Before the first application of LOCERYL, carefully clean the nails and file the affected area of the nail (especially the nail surface) as completely as possible.
Take care not to file the skin around the nail.
b) Clean the surface of the nail and remove any grease using one of the cleansing wipes provided to remove any residual varnish.
c) Apply the lacquer using one of the reusable spatulas on the entire affected nail. Clean the reusable spatula every
time you move from one nail to another to avoid contaminating the lacquer. Do not wipe the spatula on the edge of the bottle.
d) It is important to clean the reusable spatula thoroughly with one of the cleansing wipes provided after each application, before reusing it on another nail, in order to avoid contaminating the lacquer.
e) If lacquer has been deposited on the outside of the stopper during handling, it is important to clean it off using one of the cleansing wipes provided in order to avoid contact with the skin.
f) Recap the bottle tightly.
Repeat all of the above steps for each affected nail.
Cosmetic nail varnish may be applied at least 10 minutes after application of LOCERYL lacquer.
The treatment must be continued without interruption until complete regeneration of the nail and clinical and mycological healing of the affected areas.
The duration of treatment is generally 6 months for fingernails and 9 months for toenails (this depends mainly on the severity, the site of the infection and the height of the nail involvement).
Special instructions:

• Do not re-use nail files for healthy nails.
• Before each new application, file the affected nails if necessary, and in all cases clean the nails with the cleansing wipes to eliminate any residual lacquer.
• When handling organic solvents (white spirit, thinners, etc.), wear impermeable gloves to protect the LOCERYL lacquer layer on the nails.

Special warnings:
Avoid any contact of LOCERYL with the eyes, ears or mucous membranes.

LOCERYL must be used with care in patients suffering from diseases which predispose them to nail disorders (peripheral circulation disorders, diabetes, immune system disorders) as well as in patients with nail dystrophy or with seriously damaged nails (more than two thirds of the nail plate affected). In these cases a systemic treatment should be considered.
Do not use false nails during use of LOCERYL.
When handling organic solvents, wear impermeable gloves or the lacquer will be dissolved. After applying LOCERYL lacquer, wait at least 10 minutes before applying a cosmetic nail varnish. Before repeating the LOCERYL treatment, the cosmetic nail varnish must be carefully removed.
A systemic or local allergic reaction may occur after use of this medicinal product. If this happens, stop using it immediately and consult a doctor. Carefully remove the product using nail varnish remover. The medicinal product must not be used again.

Precautions for use:
In the absence of data, use of LOCERYL is not recommended in patients aged under 18 years.

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

There are limited data available on the use of amorolfine in pregnant and breast-feeding women. Only a small number of pregnancies exposed to topical amorolfine have been reported after market launch, so the potential risk is unknown.
Animal studies have shown reproductive toxicity at high oral doses (see section 5.3).
It is not known whether amorolfine is excreted in breast milk.
LOCERYL should not be used during pregnancy and breast-feeding, except when absolutely necessary.

Not applicable.

*Undesirable effects reported since market launch

Reporting of suspected adverse reactions

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:
* Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll Free phone: 8002490000
Email: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
* Other GCC Status:
Please contact the relevant competent authority.

No systemic sign of overdose is expected after topical application of LOCERYL. In the case of accidental ingestion, appropriate symptomatic measures must be taken.

Pharmacotherapeutic group: OTHER TOPICAL ANTIFUNGAL AGENTS, ATC code: 001AE16.
LOCERYL is a topical antimycotic. The active ingredient, amorolfine, derived from morpholine, belongs to a new chemical class of antimycotics.
Its antifungal and fungicidal effect is based on an alteration of the fungal cell membrane directed mainly at sterol biosynthesis.
The ergosterol content is reduced. An accumulation of atypical sterols leads to morphological changes to the cell membranes and cellular organelles, causing the death of the fungal cell.
Amorolfine has a broad antimycotic spectrum. It is highly effective against the usual or occasional agents of onychomycoses:

• Yeasts:
o Candida albicans and other Candida species,
• Dermatophytes:
o Trichophyton rubrum, Trichophyton interdigitale and Trichophyton mentagrophytes, other Trichophyton
species,
o Epidermophyton floccosum,
o Microsporum.
• Moulds:
o Scopulariopsis.
• Dematiaceous fungi (black fungi):
o Hendersonula, Alternaria, Cladosporium

• Species with low sensitivity:
Aspergillus, Fusarium, Mucorales.

Amorolfine in nail lacquer form penetrates and diffuses through the nail plate and is capable of eradicating the less accessible fungi of the nail bed.
The systemic absorption of the active ingredient is negligible, the plasma concentration remaining below the detection limit, even after one year of use.

In rats, amorolfine is not teratogenic and not embryotoxic at the maximum oral dose tested of 40 and 80mg/kg/day.
However, signs of maternal toxicity (weight loss) have been observed with 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. Weight loss in mothers, indicating maternal toxicity, has also been observed at a dose of 10 mg/kg/day.
Due to the very low systemic absorption of amorolfine following application to a nail or the skin, the potential toxicity risk for the human foetus is negligible.

Methacrylate acid copolymer (EUDRAGIT RL100), triacetin, butyl acetate, ethyl acetate, absolute ethanol.

Not applicable.

Protected from heat.
Store below 30C.

5 ml in (glass) bottle with 10 or 20 spatulas.
5 ml in (glass) bottle with accessories (30 files, 30 cleansing wipes, 30 spatulas).
5 ml in (glass) bottle with applicator cap.
5 ml in (glass) bottle with applicator cap and accessories (30 files, 30 cleansing wipes).
- Not all pack sizes may be marketed.

No special requirements