FORMULA:
Each tablet contains 281.25 mg terbinafine hydrochloride which is equivalent to 250 mg terbinafine base.

INDICATIONS:
FUNGOFIN Tablets are indicated:

• for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
• for the treatment of ringworm (tinea corporis, tinea cruris and tinea pedis) where oral therapy is considered appropriate due to the site, severity or extent of the fungal infections of the skin caused by Trichophyton (eg. T. rubrum, T.mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
• for the treatment of skin infections which caused by a yeast such as Candida (e.g. Candida albicans).

CONTRAINDICATIONS:
Fungofin Tablets are contraindicated in individuals with hypersensitivity to terbinafine or to any other ingredients of the formulation

WARNINGS/PRECAUTIONS:
FUNGOFIN Tablets are not recommended for patients with chronic or active liver disease.

Pregnancy and Nursing Mothers
Pregnancy Category B. Oral reproduction studies have been performed in laboratory animals and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine. There are, however, no adequate and well-controlled studies in pregnant women.
After oral administration, terbinafine is present in breast milk of nursing mothers. Treatment with FUNGOFIN is not recommended in nursing mothers.

DOSAGE AND ADMINISTRATION:
The duration of treatment varies according to the indication and the severity of the infection.

Adults
250 mg/day (1 FUNGOFIN 250 mg Tablet once daily)
Onychomycosis: The duration of treatment for most patients is between 6 weeks and 3 months. In the treatment of toenail infections, 3 months is usually sufficient although a few patients may require treatment of 6 months or longer.
Tinea capitis: 4 to 6 weeks
Tinea corporis, Tinea cruris and Candidiasis: 2 to 4 weeks
Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks

Children
In children 3 to 16 years of age please refer weight adjusted below scheme as guidance;
12 – 20 kg : 62.5 mg daily
20 – 40 kg : 125 mg daily
> 40 kg : 250 mg daily
Use FUNGOFIN 125 mg Tablet in pediatric patients in order to adjust appropriate dosage.

Use in the elderly
There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

OVERDOSAGE:
A few cases of overdose (up to 5 g) have been reported, giving rise to headache, nausea, epigastric pain and dizziness. The recommended treatment of overdosage consists in eliminating the drug, primarily by the administration of activated charcoal and giving symptomatic supportive therapy if needed

SIDE EFFECTS/ADVERSE EVENTS:
FUNGOFIN is well tolerated by patients. Side effects are generally mild to moderate and transient. The most common are gastrointestinal symptoms (dyspepsia, fullness, loss of appetite, nausea, mild abdominal pain, diarrhoea), allergic skin reactions (rash, urticaria) and headache. The adverse events did not lead to discontinuation from study participation.
Other adverse reactions which have been reported include malaise, fatigue, vomiting, arthralgia, myalgia and hair loss.
Patients prescribed FUNGOFIN Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient's liver function should be immediately evaluated. Changes in the ocular lens and retina have been reported following the use of terbinafine hydrochloride tablets in controlled trials; clinical significance of these changes is unknown.

CONSULT YOUR DOCTOR IF YOU NOTICE AN UNDESIRABLE EFFECT!