Terbinafine STELLA Cream 1%

OTC

Indications:

• Fungal infections of the skin caused by Trichophyton, Microsporum canis and Epidermophyton floccosum.
• Yeast infections of the skin, principally those caused by the genus Candida (e.g. C.albicans).
• Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur)

Dosage:

Apply topically once or twice daily.

Duration of treatment

Tinea corporis, cruris: 1 to 2 weeks. Tinea pedis: 1 week. Cutaneous candidiasis: 2 weeks. Pityriasis versicolor: 2 weeks. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

Usage:

Terbinafine STELLA Cream 1% is for topical use. Cleanse and dry the affected areas thoroughly before application of terbinafine cream. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal), the application may be covered with a gauze strip, especially at night.

Known hypersensitivity to terbinafine or any of the excipients contained in the cream.

• Common: Skin exfoliation, pruritus.
• Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation, pain, application site pain, irritation.
• Rare: Eye irritation, dry skin, dermatitis contact, eczema.

• The cream should not be applied to the eye nor administered intravaginally or orally. Contact with the nose, mouth, and other mucous membranes should be avoided.
• Patients should be advised to avoid the use of occlusive dressing or wrappings unless otherwise directed by their physicians.
• Topical terbinafine is not indicated for the treatment of infections involving the nails.
• Safety and efficacy of terbinafine in children younger than 12 years of age have not been established.
• Terbinafine cream should not be administered during pregnancy, unless the potential benefits outweigh any potential risks. Mothers should not receive terbinafine cream whilst breast-feeding. Infants must not be allowed to come into contact with any treated skin, including the breast.
• Terbinafine STELLA Cream 1% may cause local skin reactions (e.g. contact dermatitis), allergic reactions (possibly delayed).