AMOROLFINE

Amorolfine 5% w/v Medicated Nail Lacquer should be applied to the affected finger nails once or twice weekly or toe nails once weekly.

The patient should apply the nail lacquer as follows:

Before the first application of Amorolfine 5% w/v Medicated Nail Lacquer, 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 swab (as supplied). Before repeat application of Amorolfine 5% w/v Medicated Nail Lacquer, the affected nails should be filed down again as required, following cleansing with a cleaning swab to remove any remaining lacquer.

Caution:

Nail files used for affected nails must not be used for healthy nails. With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the spatula with the same cleaning swab used before for nail cleaning.

Keep the bottle tightly closed. For each nail to be treated, dip the spatula into the nail lacquer without wiping off any of the lacquer on the bottle neck. ) wear impermeable gloves in order to protect the Amorolfine lacquer on the nails.

Amorolfine 5% w/v Medicated Nail Lacquer is effective in moderately extensive onychomycosis. 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 twelvemonths (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. Paediatric population There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

Adverse drug reactions are rare. g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself. System Organ Class Frequency Adverse drug reaction Rare (≥1/10,000 to <1/1,000) Nail disorder, nail discoloration, onychoclasis, onychorrhexis Very rare ( <1/10,000) Skin burning sensation Skin and subcutaneous tissue disorders Not known (cannot be estimated from the available Contact dermatitis data)

Avoid contact of the lacquer with eyes, ears and mucous membranes. Use of nail varnish or artificial nails should be avoided during treatment.

1.