LAMISIL AT

Adults Lamisil AT 1% Spray is applied once daily, for one week.

Duration and frequency of treatment:

Interdigital type tinea pedis, and tinea cruris: Once a day for one week. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, a physician should be consulted.

Dosing in special populations:

Paediatric population Not to be used in children under 16 years of age. Experience with Lamisil AT 1% Spray in children is limited and its use cannot, therefore, be recommended. Elderly patients There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

Method of Administration For cutaneous use. Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area.

Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application. These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritus, rash, bullous eruptions and hives, which are reported in sporadic cases and require discontinuation.

In case of accidental contact with the eyes terbinafine hydrochloride may be irritating to the eyes. In rare cases the underlying fungal infection may be aggravated. Adverse reactions are listed below by system organ class and frequency.

Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Immune system disorders Not known:

Hypersensitivity Eye disorders Rare: Eye irritation Skin and subcutaneous tissue disorders Common: Skin exfoliation, pruritus Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation Rare: Dry skin, dermatitis contact, eczema Not known: Rash General disorders and administration site conditions Uncommon: Pain, application site pain, application site irritation Rare: Condition aggravated 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.

Lamisil AT 1% Spray should be used with caution in patients with lesions where alcohol could be irritating. Lamisil AT 1% Spray is for external use only. It may be irritating to the eyes. Lamisil AT 1% Spray should not be used on the face.

In case of accidental contact with the eyes, rinse eyes thoroughly with running water. Avoid inhalation. In case of accidental inhalation, consult a physician if any symptoms develop or persist. 56 mg alcohol (ethanol) in each daily dose which is equivalent to 250 mg/g of 96% ethanol.

It may cause burning sensation on damaged skin. 7 mg propylene glycol in each daily dose which is equivalent to 50 mg/g

1 List of excipients).