CARE ANTIFUNGAL

Posology Adults and Elderly The nail lacquer should be applied to the affected finger or toe nails once weekly. The patient should apply the nail lacquer as follows: 1. Before the first application of Care Antifungal 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 a nail file.

The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad. Cosmetic nail lacquer may be applied at least 10min after amorolfine 5% nail lacquer application. Before repeat application of Care Antifungal 5% w/v Medicated 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. Apply the nail lacquer to the entire surface of the affected nails and allow 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. ) wear impermeable gloves in order to protect the Care Antifungal 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. Non-compliance with frequency of administration and recommended treatment duration might result in treatment failure, and development of resistance.

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.

If the infection has not cleared after six months (finger nails) and twelve months (toe nails) medical advice should be sought. Co-existent tinea pedis should be treated with an appropriate antimycotic cream. Paediatric Population Due to the lack of clinical experience available Care Antifungal 5%w/v Medicated Nail Lacquer is not recommended for patients below the age of 18 years.

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 Immune system disorder Not known (cannot be estimated from available data)* Hypersensitivity (systemic allergic reaction)* Rare (≥1/10,000 to <1/1,000) Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails) Very rare (<1/10,000) Skin burning sensation Skin and subcutaneous tissue disorders Not known (cannot be estimated from the available data)* Erythema*, pruritus*, contact dermatitis*, urticarial*, blister* *post-marketing experience Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard.

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, destroyed nail plate, nail pain or inflammation should be referred to their doctor. During the application of amorolfine no artificial nails shall be use. After applying amorolfine 5% nail lacquer, an interval of at least 10min should be respected before application of any cosmetic nail lacquer.

Before repeat application of amorolfine 5% nail lacquer, the cosmetic nail lacquer should be removed carefully. When organic solvents are used impermeable gloves shall be used otherwise amorolfine nail lacquer will be removed. A systemic or local allergic reaction could possible occur after use of this product.

If this happens, the product should be stopped immediately and medical advice should be sought. Remove the product carefully by using nail remover solution. The product should not be reapplied.

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