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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Batrafen 1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciclopirox olamine, 1% w/w.
(10mg ciclopirox olamine in 1g Batrafen cream).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White to almost white cream with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Batrafen cream is indicated in the topical treatment of infections due to superficial dermatophytes, Candida species and
other fungi sensitive to the anti-infective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Topical.
Adults and Children over 6 years of age: Application 2 to 3 times daily for 2 weeks.
To avoid relapses, treatment should be continued for one to two weeks after disappearance of the symptoms, usually
within two weeks.
4.3 CONTRAINDICATIONS
Batrafen cream is contraindicated in the following:
Infants less than one year of age.
Pregnancy or in women breast feeding infants.
Patients with known hypersensitivity to any component.
Batrafen cream should not be applied to the eyes or mucosa.
Batrafen cream should not be applied to an open wound.
Batrafen cream contains paraffin which can cause leaking or breaking of latex condoms. Contact between Batrafen
cream and latex condoms must therefore be avoided because the protection afforded by the condoms may otherwise be
lost.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/11/2010_
_CRN 2067679_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
All possibly infected areas should be treated at the same time.
Local irritation may develop. If this is severe, treatment should be discontinued.
The duration of application sh
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