TERBINAFINE HYDROCHLORIDE

Posology Terbinafine cream can be applied once or twice daily. The duration of treatment depends on the indication and severity of infection.

The likely durations of treatment are 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. Paediatric population The experience with topical terbinafine in children is still limited and its use cannot therefore be recommended. Elderly There is no evidence to suggest that older patients require different dosages or experience side-effects different to those of younger patients.

Method of administration Via the topical route. Cleanse and dry the affected areas thoroughly before application of Terbinafine cream. 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.

Ensure that new gauze is used after each application if required.

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

In case of accidental contact with the eyes terbinafine 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, application site irritation Rare Condition aggravated *: Based on post-marketing experience 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.

Terbinafine cream is for external use only. It may be irritating to the eyes. In case of accidental contact with the eyes, rinse eyes thoroughly with running water and contact an ophthalmologist if necessary. Terbinafine cream should be kept out of the sight and reach of children.

g. contact dermatitis). This medicinal product contains 10 mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.

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