Galderma (U.K) Ltd

Loceryl 5% w/v Medicated Nail Lacquer

Loceryl nail lacquer contains 5% w/v amorolfine in the form of amorolfine hydrochloride.

For a full list of excipients, see section 6.1.

Medicated Nail Lacquer.

A clear colourless to almost colourless liquid

Onychomycoses caused by dermatophytes, yeasts and moulds.

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

The required 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).

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 treatment.

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.

Caution: Loceryl nail lacquer should not be applied to the nail bed as it may cause localised effects such as contact dermatitis.

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.

None

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.

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 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.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Ammonio methacrylate copolymer A

Triacetin

Butyl acetate

Ethyl acetate

Ethanol Anhydrous

Not applicable

3 years

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

Amber glass type I bottle 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) Ltd,

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

PA 590/18/1

Date of first authorisation: 25^th March 1993

Date of last renewal: 25th March 2008

May 2012