Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CICLOPIROX OLAMINE
Sanofi-Aventis Ireland Limited
1 %w/w
Cutaneous Powder
1999-11-12
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Batrafen 1% w/w Cutaneous Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ciclopirox Olamine 1% w/w. (10mg ciclopirox Olamine in 1g Batrafen powder). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous Powder White to almost white, loose powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Batrafen powder is indicated for use 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. Sufficient experience is not yet available on the use of Batrafen powder in children under 6 years. Batrafen Powder should be sprinkled onto the infected area. Additional hygienic measures (e.g. sprinkling powder into socks or shoes) are recommended. The product should not be used on open wounds, on the eyes or mucosal passages or in conjunction with make up. 4.3 CONTRAINDICATIONS Batrafen powder 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 powder should not be applied to the eyes or mucosa. Batrafen powder should not be applied to an open wound. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/12/2006_ _CRN 2030715_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE All possibly infected areas should be treated Read the complete document