LAMISIL ONCE

For Cutaneous Use Adults 18 years of age and over: single administration. Duration and frequency of treatment Lamisil Once 1% cutaneous solution should be applied once on both feet, even if lesions are visible on one foot only. This ensures elimination of the fungi (dermatophytes) that might be found in areas of the foot where no lesions are visible.

Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after one week, patients should see a doctor. There are no data on repeated treatment with Lamisil Once 1% cutaneous solution. Therefore a second treatment cannot be recommended within a particular episode of athlete’s foot.

Dosing in special populations Paediatric population Lamisil Once 1% cutaneous solution has not been studied in the paediatric population. Its use is therefore not recommended in patients below 18 years of age. 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 Patients should wash and dry both feet and hands before applying the product. They should treat one foot, then the other. 5 cm. The product should be applied in the same way to the other foot, even if the skin looks healthy.

The product should be left to dry to a film for 1-2 minutes. Patients should then wash their hands. Lamisil Once 1% cutaneous solution should not be massaged into skin. For the best results, the treated area should not be washed for 24 hours after application.

It is therefore recommended to apply Lamisil Once 1% cutaneous solution after a shower or bath and wait until the same time the following day before washing the feet again. Patients should use the quantity they need to cover both feet as instructed above.

Any unused medication is to be discarded.

Summary of the safety profile Undesirable effects include mild and transient reactions at the site of application. In very rare instances, allergic reactions may occur. Tabulated list of adverse reactions 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 to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Description of selected adverse reactions Skin and subcutaneous tissue disorders:

Very rare (<1/10,000, including isolated reports): allergic reactions such as rash, pruritus, dermatitis bullous and urticaria. General disorders and administration site conditions Uncommon (>1/1,000, <1/100): application site reactions such as skin dryness, skin irritation or burning sensation.

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. uklyellowcard.

Lamisil Once 1% cutaneous solution is not recommended to treat hyperkeratotic chronic plantar tinea pedis (moccasin type). Lamisil Once 1% cutaneous solution: • Should be used with caution in patients with lesions where alcohol could be irritating (after sun exposure or severe skin scaling).

• Should not be used on the face. • For external use only. • May be irritating to the eyes. 75 mg/g of 96% ethanol. It may cause burning sensation on damaged skin. Do not swallow. Keep out of sight and reach of children. In the event of allergic reaction, the film should be removed with an organic solvent such as denatured alcohol and the feet washed with warm soapy water.

• Keep away from naked flames.

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