TERBINAFINE

Posology Adults and adolescents (>12 years of age) Duration and frequency of treatment: Terbinafine can be applied once or twice daily.

The likely duration of each treatment is as follows:

Tinea pedis: 1 week. Tinea cruris and Tinea corporis: 1 to 2 weeks. Cutaneous candida: 2 weeks. Pityriasis versicolor: 2 weeks. Relief of symptoms is usually obtained within a few days. Irregular use or an inadequate treatment period increases the risk of the symptoms returning.

If no improvement is obtained after 2 weeks, the diagnosis should be re- evaluated. Elderly There has been nothing to indicate that elderly patients require a different dosage or have a side effects profile different from younger patients.

Paediatric population Terbinafine 1 % Cream is not recommended for children below 12 years of age due to insufficient data on safety. The experience in children is limited. Method of administration For cutaneous use. The skin should be clean and dry.

The cream should be applied in a thin layer on and around the affected skin and rubbed in gently. In cases of reddened and weeping infection (under the breasts, between the fingers, buttocks or in the groin) the skin may be covered with a sterile compress after application of the cream, especially at night.

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 the 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), not known (cannot be estimated from the 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.

Terbinafine 1 % Cream cream is for external use only. Terbinafine 1 % Cream cream may be irritating to the eyes. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Terbinafine cream should be kept out of the reach of children. In the event of allergic reaction, the cream should be removed and the treatment interrupted. Instruct patients not to smoke or go near naked flames - risk of severe burns.

Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Candidiasis:

It is not recommended to use acid pH soap. This provides favourable growth conditions for Candida spp. Excipients This medicine contains 10 mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.

g. contact dermatitis).

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