Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FUSIDIC ACID BETAMETHASONE
IPS Healthcare Limited
20mg/g + 1 mg/g
Cream
2011-09-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucibet Lipid 20 mg/g + 1 mg/g cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fucibet Lipid cream contains Fusidic acid 20mg/g and Betamethasone 1mg/g (as the valerate ester). Excipients: contains cetostearyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and potassium sorbate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. _Product imported from the UK:_ A white highly viscous oil-in-water emulsion cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Use in inflammatory dermatoses where bacterial infection is present or likely to occur. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply a small quantity to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. 4.3 CONTRAINDICATIONS Known hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or any of the excipients. Due to the content of corticosteroid, Fucibet Lipid is contraindicated in the following conditions: skin infections primarily caused by bacteria, fungi or virus (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Long-term continuous topical therapy should be avoided, particularly in infants and children. Adrenal suppression can occur even without occlusion. Atrophic changes may occur on the face, and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids. Caution should be exercised if Fucibet lipid cream is used near the eye. Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial infe Read the complete document