Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE
Stiefel Laboratories (U.K.) Ltd.
5 %w/w
Gel
1979-08-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acetoxyl 5 Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrous Benzoyl Peroxide equivalent to Benzoyl peroxide 5%w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Gel A white gel, free from gritty particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acetoxyl 5 Gel is indicated for the treatment of mild to moderate acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults Apply to the whole of the affected area once or twice daily. Wash with soap and water prior to application. Paediatric use The safety and efficacy of Acetoxyl 5 Gel has not been established in children since acne vulgaris rarely presents in this age group. Elderly patients There are no specific recommendations. Acne vulgaris does not present in the elderly. 4.3 CONTRAINDICATIONS Patients with known hypersensitivity to any of the ingredients should not use the 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 coloured or dyed fabrics. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/07/2006_ _CRN 2025170_ _page number: 1_ 4.6 PREGNANCY AND LACTATION The safety of benzoyl peroxide in human pregnancy is established. There are no restrictions on the use of Acetoxyl 5 Gel during pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS In normal use, a mild burning sensation will probably be felt on first application and a mode Read the complete document