ABBREVIATED PRESCRIBING INFORMATION FOR FUCIDIN® H 20 MG/10 MG PER GRAM
Active ingredients: fusidic acid 20 mg/g, hydrocortisone acetate 10 mg/g. inactive ingredients: butylatedhydroxyanisole, cetyl
alcohol, glycerol 85%, liquid paraffin, polysorbate, potassium sorbate, white soft paraffin, purified water.
Fusidic acid and hydrocortisone acetate (Fucidin® H) Cream is indicated for the treatment of dermatitis, including atopic dermatitis and contact dermatitis, where an infection with bacteria sensitive to fusidic acid is suspected or confirmed. Because
of its hydrocortisone content, Fucidin® H Cream is particularly appropriate in cases where a milder corticosteroid is indicated,
including milder inflammatory dermatoses - on the face and on children’s skin. Fucidin® H Cream is cosmetically acceptable for use on the face and hands and convenient for use in the groin area and armpits.
DOSAGE AND ADMINISTRATION
Apply the cream three times daily for up to 2 weeks.
Hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or to any of the excipients listed above (see Formulation). Due to the content of corticosteroid, Fucidin® H is contraindicated in the following conditions: Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate. Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy. Perioral dermatitis and rosacea.
The most frequently reported adverse reactions during treatment are application site reactions including pruritus, burning and irritation. Hypersensitivity is an uncommon undesirable effect of topically administered Fucidin® H cream.
SHELF LIFE AND STORAGE CONDITIONS:
To be stored up to 3 years at temperatures not exceeding 25°C. See the expiry date printed on the carton.
Fucidin® H 20 mg/10 mg per gram Topical Cream API version JAN2019