TROSYL NAIL

Route of administration:

Topical. Adults The solution should be applied to the affected nails and immediately surrounding skin every twelve hours using the applicator brush supplied. The duration of treatment is up to six months but may be extended to twelve months.

Use in the elderly No special precautions are required. Use the adult dose. Use in children No special precautions are required. Use the adult dose.

Trosyl Nail Solution is well tolerated following local application. Symptoms of local irritation have been reported by some patients, but are usually seen during the first week of treatment and are transient and mild. Systemic allergic reactions are uncommon.

However, if a sensitivity reaction develops with the use of Trosyl Nail Solution, treatment should be discontinued and appropriate therapy instituted. The undesirable effects listed below were reported with frequencies corresponding to Common (≥1/100, ≤1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000 to <1/1,000), or Very rare (<1/10,000) not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Frequency Undesirable effects Immune system disorders Unknown Allergic reaction Nervous system disorders Unknown Paraesthesia Unknown Bullous eruption, dermatitis contact, dry skin, edema periorbital, nail disorder (including nail discoloration, periungual inflammation and nail pain), pruritis, skin irritation, skin exfoliation, urticaria Skin and subcutaneous tissue disorders Uncommon Dermatitis, rash Common Oedema peripheralGeneral disorders and administration site conditions Unknown Pain, burning sensation Anaphylactoid reactions have been reported in patients treated with other formulations than the dermatological preparation.

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. uk/yellowcard

Trosyl Nail Solution is not for ophthalmic use.

1. Trosyl Nail Solution is contraindicated in individuals who have been shown to be hypersensitive to imidazole antifungal agents. 6).