ABBREVIATED PRESCRIBING INFORMATION FOR FUCIDIN® 2% CREAM

FORMULATION

Each gram contains: Fusidic acid 20 mg. in neutral cream base.

INDICATIONS

Fusidic acid (Fucidin®) cream is indicated for treatment of skin infections caused by staphylococci, streptococci,
Propionibacterium acnes, Corynebacterium minutissimum, and other organisms sensitive to fusidic acid. The most important indications being: impetigo, boils, carbuncles, paronychia, infected wounds, sycosis barbae, hidradenitis, erythrasma, folliculitis, acne vulgaris. Fusidic acid (Fucidin®) cream is an invisible, non-staining preparation, which is cosmetically acceptable for treatment of face and scalp infections.

APPLICATION

Fusidic acid (Fucidin®) cream is applied to the affected area 2–3 times daily, generally for a period of 7 days, except of acne where therapy should be extended for a longer period according to the nature of this disease.

SIDE-EFFECTS

Fusidic acid (Fucidin®) cream is remarkably well tolerated, and there is an extremely low frequency of hypersensitivity reactions. Keep out of reach of children.

STORAGE

Store at temperatures not exceeding 30°C.

Fucidin® 2% Cream API version JAN2019

ABBREVIATED PRESCRIBING INFORMATION FOR FUCIDIN® 2% OINTMENT

FORMULATION

Each gram contains: Sodium fusidate 20 mg. in neutral ointment base.

INDICATIONS

Fusidate sodium (Fucidin®) ointment is indicated for treatment of skin infections caused by staphylococci, streptococci,
Corynebacterium minutissimum and other organisms sensitive to sodium fusidate; the most important indications being: impetigo, boils, hidradenitis, infected wounds, sycosis barbae, paronychia, folliculitis, carbuncles, erythrasma.

DOSAGE AND ROUTE OF ADMINISTRATION

Fusidate sodium (Fucidin®) ointment is applied to the affected area 2–3 times daily, generally for a period of 7 days. It can be
used with or without a covering dressing. Caution should be observed when applying Fusidate sodium (Fucidin®) ointment in
the eye region as this preparation may cause irritation if it gets into the eye.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

UNDESIRABLE EFFECTS

The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients. Hypersensitivity is a rare undesirable effect of topically administered Fucidin® Ointment.

STORAGE

Store at temperatures not exceeding 30°C.

Fucidin® 2% Ointment API version JAN2019

ABBREVIATED PRESCRIBING INFORMATION FOR FUCIDIN® H 20 MG/10 MG PER GRAM
TOPICAL CREAM

FORMULATION

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.

INDICATIONS

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.

CONTRAINDICATIONS

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.

UNDESIRABLE EFFECTS

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

ABBREVIATED PRESCRIBING INFORMATION FOR FUCICORT® 20 MG/1 MG PER GRAM TOPICAL CREAM

FORMULATION

Each gram contains: fusidic acid 20 mg, betamethasone as valerate 1 mg, preserved with chlorocresol.

INDICATIONS

Fusidic acid and betamethasone valerate (Fucicort®) cream is indicated in inflammatory dermatoses where bacterial infection is present or likely to occur. Inflammatory dermatoses include atopic eczema, discoid eczema, stasis eczema, seborrhoeic dermatitis, contact dermatitis, lichen simplex chronicus, psoriasis, discoid lupus erythematosus.

DOSAGE AND ADMINISTRATION

Uncovered lesions: 2-3 daily applications. Covered lesions: Less frequent application may be adequate.

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in viral, tuberculous and fungal skin infections, perioral dermatitis, acne rosacea and ulcerative condition. Hypersensitivity to any component.

ADVERSE DRUG REACTIONS

Hypersensitivity has rarely been encountered. As with other topical corticosteroids, prolonged and intensive treatment may cause local atrophic changes of the skin, such as striae, thinning and dilatation of the superficial blood vessels, particularly when occlusive dressing is used or when skin folds are involved. Systemic absorption, sufficient to produce hypercorticism/adrenal suppression, can occur with prolonged or extensive use, especially when used under occlusion/napkin. Infants and children are particularly at risk. Caution should be exercised if a topical steroid is used near the eye. Glaucoma might be the result if the preparation enters the eye.

SHELF LIFE AND STORAGE CONDITIONS:

Store below 30°C. Keep out of reach of children.

Fucicort® 20 mg/1 mg per gram Topical Cream API version JAN2019

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