LAMISIL

LAMISIL can be applied once or twice daily. Duration and frequency of treatment The likely duration of each treatment is as follows: Tinea corporis, cruris: 1 to 2 weeks Tinea pedis: 1 week Cutaneous candidiasis: 2 weeks Pityriasis versicolor: 2 weeks 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, the diagnosis should be verified.

Dosing in special populations:

Paediatric population The experience with topical LAMISIL in children is still 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 to those of younger patients.

Method of administration For cutaneous use. Cleanse and dry the affected areas thoroughly before application of LAMISIL. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

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 pruritis, rash, bullous eruptions and hives which are reported in sporadic cases but 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 to 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,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

Cream is for external use only. Contact with the eyes should be avoided. May be irritating to the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water. LAMISIL Cream contains 36 mg benzyl alcohol in each daily dosage which is equivalent to 10 mg/g.

Benzyl alcohol may cause allergic reactions. g. contact dermatitis).

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