Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE
Stiefel Laboratories (U.K.) Ltd.
BENZOYL PEROXIDE
5 %w/w
Cream
Withdrawn
2009-05-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PanOxyl 5% Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzoyl Peroxide Hydrous Ph. Eur. equivalent to Benzoyl Peroxide anhydrous 5.00 %w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream A smooth homogeneous white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PanOxyl 5 Cream is indicated for the treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply to the affected area once daily. Washing with soap and water prior to application greatly enhances the efficacy of the preparation. 4.3 CONTRAINDICATIONS Patients with a known hypersensitivity to benzoyl peroxide should not use this product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with the eyes, mouth and other mucous membranes. Care should be taken when applying the product to the neck and other sensitive areas. The product may bleach dyed fabrics. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 PREGNANCY AND LACTATION There are no restrictions on the use of the product during pregnancy or lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/12/2006_ _CRN 2031197_ _page number: 1_ 4.8 UNDESIRABLE EFFECTS In normal use, a mild burning sensation will probably be felt on first application and a moderate reddening and peeling of the skin will occur within a few days. During the first few weeks of treatment a sudden increase in peeling will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICA Прочитайте повний документ