AMORSTAD

Posology Adults and Elderly 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 Amorstad 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 an alcohol cleaning pad. Before repeat application of Amorstad 5% w/v Medicated Nail Lacquer, 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. Allow the nail lacquer to dry for 3-5 minutes.

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.

) wear impermeable gloves in order to protect the Amorstad 5% w/v Medicated Nail 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.

Children Amorstad 5% w/v Medicated Nail Lacquer is not recommended for use in children due to a lack of data on safety or efficacy. Method of Administration Cutaneous use.

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 Skin and subcutaneous tissue disorders Very rare (<1/10,000) Skin burning sensation, contact dermatitis

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. Use of nail varnish or artificial nails should be avoided during treatment. As no clinical data is available, amorolfine is not recommended in children.

Amorstad 5% w/v Medicated Nail Lacquer must not be reused by patients who have shown hypersensitivity to the treatment. Hypersensitivity to the active substance amorolfine or to any of the excipients.