Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE
GlaxoSmithKline (Ireland) Limited
BENZOYL PEROXIDE
10 %w/w
Gel
Product not subject to medical prescription
Withdrawn
2013-10-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PanOxyl Acnegel 10% w/w gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzoyl peroxide hydrous equivalent to Benzoyl Peroxide anhydrous 10.00 % w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel A white creamy homogenous gel free from gritty particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PanOxyl 10 Gel 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 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 FERTILITY, 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 30/01/2012_ _CRN 2108569_ _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 disc Read the complete document