Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
AMYLMETACRESOL 2, 4-DICHLOROBENZYL ALCOHOL
Reckitt Benckiser Ireland Ltd
AMYLMETACRESOL 2, 4-DICHLOROBENZYL ALCOHOL
0.6/1.2 Milligram
Lozenges
Product not subject to medical prescription
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Original Lozenges Amylmetacresol 0.6 mg 2, 4-dichlorobenzyl alcohol 1.2 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains: Amylmetacresol 0.6 mg 2,4-Dichlorobenzyl alcohol 1.2 mg Also contains glucose 1g, sucrose 1.5g, carmoisine (E122) and Ponceau 4R (E124). For a full list excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge A circular, biplanar red lozenge with an aniseed odour, embossed on both sides with strepsils brand icon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For mouth and throat infections 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children: One lozenge to be dissolved slowly in the mouth every 2-3 hours or as directed by a physician. Elderly: There is no need for dosage reduction in the elderly. For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Keep all medicines out of reach of children. Consult your doctor if symptoms persist or if anything unusual happens. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/12/2013_ _CRN 2141175_ _page number: 1_ No clinically significant interactions are known. 4.6 FERTILITY, PREGNANCY AND LACTATION The safety of Strepsils during pregnancy and lactation has not been established, but it is not considered to constitute a hazard during these periods. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No adverse effects a Lees het volledige document