Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MEPYRAMINE MALEATE BENZOCAINE
Sanofi-Aventis Ireland Limited
2/2 %w/w %w/w
Cutaneous Spray Solution
2000-01-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anthisan Plus Sting Relief Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mepyramine Maleate 2% w/w. Benzocaine 2% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray, solution A clear, colourless to slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief in insect bites and stings, and nettle stings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Each metered dose delivers 2 mg mepyramine maleate and 2 mg benzocaine. Adults, elderly and children over 12 years: Pressing the nozzle head once delivers a single metered dose. Two to three metered doses to be sprayed on to the site of the bite or sting two or three times a day for up to three days. Early application is essential to obtain optimum response. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Anthisan Plus Sting Relief Spray should not be used in eczematous conditions or on extensively broken skin surfaces. Do not use on large areas of skin or on areas of sunburnt skin. Do not use near the eyes or mouth. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Repeated applications of Anthisan Plus Sting Relief Spray for longer than a few days are not recommended and treatment should be discontinued immediately if skin sensitisation occurs. The spray should not be applied near a naked flame. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/12/2006_ _CRN 2031448_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No clinically significant interactions following topical use are known. 4.6 PREGNANCY AND LACTATION There is inadequate evidence for the safety o Read the complete document