LOCERYL Nail lacquer Ref.[6176] Active ingredients: Amorolfine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Therapeutic indications

Onychomycoses caused by dermatophytes, yeasts and moulds.

Posology and method of administration

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).

Cosmetic nail lacquer may be applied at least 10 min after amorolfine 5% nail lacquer application.

Before repeat application of amorolfine 5% nail lacquer, any remaining nail lacquer, and cosmetic nail lacquer if any, should be removed carefully, then the affected nails should be filed down again as required, and at any rate be cleansed with an alcohol soaked swab 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.

Older people

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

Paediatric population

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

Overdose

No systemic signs of overdose are expected following topical application of amorolfine 5% nail lacquer.

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

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 30°C. Protect from heat. Keep bottle tightly closed after use.

Nature and contents of container

Amber glass type I bottle with screw thread and plastic screw closure.

Packs contain cleansing swabs, spatulas and nail files.

Or

Amber glass type III bottle with screw thread and plastic screw closure with integrated applicator.

Packs contain cleansing swabs and nail files.

Pack Sizes:

2.5 ml (1 × 2.5 ml)
5.0 ml (1 × 5.0 ml)
7.5 ml (1 × 2.5 ml & 1 × 5.0 ml)
10.0 ml (2 × 5.0 ml)

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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