LAMISIL TABLET 250 mg

INDICATIONS

Treatment of:

• Onychomycosis (fungal infection of the nail) caused by dermatophyte fungi.

• Tinea capitis.

• Fungal infections of the skin (Tinea corporis, Tinea cruris, Tinea pedis) and yeast infections of the skin caused by the genus Candida (e.g. Candida albicans) where oral therapy is generally considered appropriate owing to the site, severity or extent of the infection.

Note: In contrast to topical Lamisil, oral Lamisil is not effective in Pityriasis versicolor (also known as Tinea versicolor).

CONTRAINDICATIONS

• Known hypersensitivity to terbinafine or to any of the excipients of Lamisil tablets.

• Chronic or active hepatic diseases

DOSAGE REGIMEN AND ADMINISTRATION

Dosage Regimen

The duration of treatment varies according to the indication and the severity of the infection.

Adults

250 mg once daily.

Skin infections

Recommended duration of treatment:

• Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks.
• Tinea corporis, T. cruris: 2 to 4 weeks.
• Cutaneous candidiasis: 2 to 4 weeks.

Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.

Hair and scalp infections

Recommended duration of treatment:

• Tinea capitis: 4 weeks.

Tinea capitis occurs primarily in children.

Onychomycosis

For most patients the duration of successful treatment is 6 to 12 weeks.

Fingernail onychomycosis

Six weeks of therapy is sufficient for fingernail infections in most cases.

Toenail onychomycosis

Twelve weeks of therapy is sufficient for toenail infections in most cases.

Some patients with poor nail outgrowth may require longer treatment. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

Special populations

Hepatic impairment

Lamisil tablets are contraindicated for patients with chronic or active hepatic disease (see sections CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

The use of Lamisil tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population (see section WARNINGS AND PRECAUTIONS and section PHARMACOKINETICS (PK) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric Patients

There is no evidence to suggest that elderly patients (aged 65 years and above) require different dosages or experience different side effects than younger patients. When prescribing Lamisil tablets for patients in this age group, the possibility of pre-existing impairment of liver or kidney function should be considered (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric Patients

No data are available in children under two years of age (usually <12 kg).

Children weighing<20 kg62.5 mg(half a 125 mg tablet) once dailyChildren weighing20 to 40 kg125 mg(one 125 mg tablet) once dailyChildren weighing>40 kg250 mg(two 125 mg tablets) once daily

Method of administration

The scored tablets are taken orally with water. They should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal.