Loceryl 5% w/v Medicated Nail Lacquer

Loceryl nail lacquer contains 5% w/v amorolfine in the form of hydrochloride. Amorolfine is chemically described as cis-4-[(RS)-3[4-(1,1-Dimethylpropyl)phenyl]-2-methylpropyl]-2,6-dimethylmorpholine.

Amorolfine hydrochloride HSE 6.40 w/w

For a full list of excipients, see section 6.1

Medicated Nail Lacquer.

Onychomycoses caused by dermatophytes, yeasts and moulds.

The nail lacquer should be applied to the affected finger or toe nails once weekly. Twice weekly application may prove beneficial in some cases.

The patient should apply the nail lacquer as follows:

1. Before the first application of Loceryl, 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 a cleaning pad (as supplied). Before repeat application of Loceryl, 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.

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

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.

Elderly

There are no specific dosage recommendations for use in elderly patients.

Children

There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

Loceryl nail lacquer must not be reused by patients who have shown hypersensitivity to the active substance or to any of the excipients.

No experience exists of use during pregnancy and nursing, therefore, the use of Loceryl should be avoided during pregnancy and lactation.

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

There are no specific studies involving concomitant treatment with other topical medicines.

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

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 foetus appears to be negligible. However, because there is no relevant experience, Loceryl should be avoided during pregnancy and breast feeding.

Loceryl Nail Lacquer has no influence on the ability to drive and use machines.

Adverse drug reactions are rare. Nail disorders (e.g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself.

Contact dermatitis (unknown frequency) has been reported in spontaneous reports.

Accidental oral ingestion

Loceryl is for topical use. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.

Pharmacotherapeutic Group: Other antifungals for topical use ATC code: D01AE16

Loceryl is a topical antimycotic. Amorolfine 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

With the exception of Actinomyces, bacteria are not sensitive to amorolfine. Propionibacterium acnes is only slightly sensitive.

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 Loceryl Nail Lacquer, there is no indication of drug accumulation in the body.

None stated.

Ammonio methacrylate copolymer A

triacetin

butyl acetate

ethyl acetate

ethanol absolute.

Not applicable

3 years.

Loceryl nail lacquer should be stored below 30°C. Protect from heat. Keep bottle tightly closed after use.

Amber glass container with screw thread and plastic screw closure.

All packs contain cleansing swabs, spatulas and nail files.

Not all pack sizes may be marketed

No special requirements.

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

PL 10590/0042

April 1999

November 2010