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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
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