Composition:

• Fungiben 250 mg Tablet: Each tablet contains Terbinafine Hydrochloride EP equivalent to Terbinafine 250 mg.

Pharmacology:

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

• Terbinafine distributes into tissues and has a long terminal elimination half-life, resulting in a long duration of action.

• Patients taking oral Terbinafine should have liver function tests performed prior to treatment to reduce the risk of liver injury.

Indications:

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

• Hair and scalp infection (Tinea capitis).

• Candidiasis.

• Pityriasis versicolor.

• Onychomycosis.

Dosage & Administration:

• Onychomycosis: 250 mg once daily for 6 weeks.

• Tinea Cruris: 250 mg once daily for 2–4 weeks.

• Tinea Pedis: 250 mg once daily for 2–6 weeks.

• Tinea Corporis: 250 mg once daily for 4 weeks.

• Hair and skin infections: 250 mg once daily for 2–6 weeks.

• Or as directed by the registered physicians.

Use in Children:

• The safety and efficacy of Terbinafine tablets have not been established in pediatric patients with onychomycosis.

Contraindications:

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

Side Effects:

• Common side effects include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain and flatulence.

• Terbinafine may occasionally cause severe liver toxicity, changes in taste or loss of taste, and serious skin or allergic reactions.

Warning & Precaution:

• Terbinafine is not recommended for patients with chronic or active liver disease.

• Pre-existing liver disease should be assessed before prescribing Terbinafine.

• Hepatotoxicity may occur in patients with or without pre-existing liver disease.

• Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before taking Terbinafine Tablets.

Drug Interactions:

• Oral Terbinafine is an inhibitor of the Cytochrome P450 2D6 isozyme.

• Terbinafine may affect the metabolism of Desipramine, Cimetidine, Fluconazole, Cyclosporine, Rifampin and Caffeine.

• 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 250 mg Tablet: Each box contains 10 tablets in Alu-Alu blister pack.