Composition:

• Fungiben 1% Cream: Each gram of cream contains Terbinafine Hydrochloride EP 10 mg.

Pharmacology:

• Terbinafine is an allylamine antifungal that inhibits squalene epoxidase, preventing the formation of ergosterol and causing an accumulation of squalene, which weakens the cell wall of fungal cells.

Indications:

• Fungal infections of the skin, including Tinea corporis, Tinea cruris and Tinea pedis.

• Cutaneous candidiasis.

• Pityriasis versicolor.

Dosage & Administration:

• Tinea Cruris & Corporis: Apply once or twice daily for 1–2 weeks.

• Tinea Pedis: Apply once daily for 1 week.

• Cutaneous candidiasis & Pityriasis versicolor: Apply once or twice daily for 2 weeks.

• Or as directed by the registered physicians.

Use in Children:

• The safety and efficacy of Terbinafine Hydrochloride cream have not been established in pediatric patients.

Contraindications:

• Terbinafine is contraindicated in patients with known hypersensitivity to the cream or any ingredient in the formulation.

Drug Interactions:

• There is no known drug interaction when Terbinafine is taken topically.

Use in Pregnancy & Lactation:

• Pregnancy Category B.

• There are no adequate and well-controlled studies in pregnant women.

• Terbinafine should not be initiated during pregnancy when treatment of onychomycosis can be postponed until after pregnancy.

• After oral administration, Terbinafine is present in the breast milk of nursing mothers.

• Treatment with Terbinafine is not recommended in nursing mothers.

Storage:

• Store below 30°C.

• Protect from light and moisture.

• Store in a dry and cool place.

• Keep out of reach of children.

Packing:

• Fungiben 1% Cream: Each pack contains a laminate tube containing 30 g cream.