TIOCONAZOLE

Route of administration:

Cutaneous use.

Posology 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 depends on the severity of the infection, the infectious microorganism and the location of the area to be treated.

Usually, 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.

Paediatric population:

No special precautions are required. Use the adult dose.

Tioconazole is well tolerated upon local application. The most common effect is local irritation (including local allergic reactions), 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 Tioconazole, 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 Frequency Immune system disorders Unknown Allergic reaction Nervous system disorders Unknown Paresthesia 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Tioconazole is not for ophthalmic use.

1. Tioconazole is contra-indicated in individuals who have been shown to be hypersensitive to imidazole antifungal agents. 6).