AMOROLFINE 5% MEDICATED NAIL LACQUER - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Amorolfine 5% Medicated nail lacquer

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Amorolfine contains 5% w/v amorolfine in the form of hydrochloride. 1 ml solution contains 55.74 mg amorolfine hydrochloride (equivalent to 50 mg amorolfine).

For the full list of excipients, see section 6.1.

Medicated nail lacquer.

Clear, colourless to pale yellow solution.

4.1 Therapeutic indications

Treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds; treatment is limited to 2 nails.

4.2 Posology and method of administration

Posology

Adults and elderly

The nail lacquer should be applied to the affected finger or toe nails once weekly.

The patient should apply the nail lacquer as follows:

1. Before the first application of amorolfine, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using the nail file supplied. The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad. Before repeat application of amorolfine, the affected nails should be filed down again as required, following cleansing with a cleaning pad to remove any remaining lacquer.

Caution: Nail files used for affected nails must not be used for healthy nails.

2. With one of the reusable applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the applicator with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.

For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck.

Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treatment depends essentially on intensity and localisation of the infection. In general, it is six months (finger nails) and nine to twelve months (toe nails). A review of the treatment is recommended at intervals of approximately three months.

Co-existent tinea pedis should be treated with an appropriate antimycotic cream.

Paediatric population

Amorolfine is not recommended for use in children and adolescents below 18 years due to a lack of data on safety or efficacy.

Method of administration

Cutaneous use (application on the nail).

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

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

Patients with underlying conditions predisposing to fungal nail infections should be referred to a doctor. Such conditions include peripheral circulatory disorders, diabetes mellitus, and immunosuppression.

Patients with nail dystrophy and destroyed nail plate should be referred to their doctor.

When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the amorolfine lacquer on the nails.

During the application of amorolfine no cosmetic nail lacquer or artificial nails shall be used.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Use of nail varnish or artificial nails should be avoided during treatment.

4.6 Fertility, pregnancy and lactation

Pregnancy

Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals but embryotoxicity was observed at high oral doses. The systemic absorption of amorolfine during and after topical administration is very low and therefore the risk to the human fetus appears to be negligible. However, because there is no relevant experience, amorolfine should be avoided during pregnancy.

Breastfeeding

It is unknown whether amorolfine is excreted in human milk. Because there is no relevant experience, amorolfine should be avoided during breast feeding.

Fertility

No data are available.

4.7 Effects on ability to drive and use machines Not relevant.

4.8 Undesirable effects

5   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: other antifungals for topical use, ATC code: D01AE16

Amorolfine is a topical antimycotic. It belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.

Amorolfine is a broad spectrum antimycotic. It is highly active (MIC < 2mcg/ml) in vitro against

– yeasts: Candida, Cryptococcus, Malassezia

– dermatophytes: Trichophyton, Microsporum, Epidermophyton

– moulds: Hendersonula, Alternaria, Scopulariopsis

– dematiacea: Cladosporium, Fonsecaea, Wangiella

– dimorphic fungi: Coccidioides, Histoplasma, Sporothrix

With the exception of Actinomyces, bacteria are not sensitive to amorolfine.

Propionibacterium acnes is only slightly sensitive.

5.2 Pharmacokinetic properties

Amorolfine from nail lacquer penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of the active ingredient is very low with this type of application.

Following prolonged use of amorolfine, there is no indication of drug accumulation in the body.

5.3 Preclinical safety data

There are no findings of relevance to the prescriber other than those mentioned elsewhere in the SPC.

6.1 List of excipients

Eudragit RL 100 Triacetin

Butyl acetate Ethyl acetate Ethanol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 30°C. Protect from heat. Keep the bottle tightly closed and upright.

6.5 Nature and contents of container

The lacquer is available in a glass bottle of 2.5 ml. The bottle is made of amber glass (type I or type III) bottle with a HDPE cap, PTFE liner and tamper evident ring.

Each pack consists of 1 bottle and cleansing swabs, spatulas and nail files.

6.6 Special precautions for disposal No special requirements.