FUCIBET 20/1 mg/g Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
31-05-2024
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Active ingredient:
FUSIDIC ACID ANHYDROUS, BETAMETHASONE VALERATE
Available from:
Clear Pharmacy
ATC code:
D07CC01
INN (International Name):
FUSIDIC ACID ANHYDROUS, BETAMETHASONE VALERATE
Dosage:
20/1 mg/g
Pharmaceutical form:
Cream
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Corticosteroids, potent, combinations with antibiotics
Authorization status:
Authorised
Authorization date:
2011-02-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucibet 20 mg/g + 1 mg/g cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g and betamethasone 1 mg/g (as betamethasone valerate).
Excipients: cetostearyl alcohol and chlorocresol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from the UK:_
A white 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 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 cream is used near
the eye. Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial
infection persists.
Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or
recurrent use may increase
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