Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
DEQUALINIUM CHLORIDE
Reckitt Benckiser Ireland Ltd
DEQUALINIUM CHLORIDE
0.25 Milligram
Lozenges
Product not subject to medical prescription
Authorised
0000-00-00
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dequadin 0.25 mg Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 0.25 mg dequalinium chloride Excipient: Sunset yellow (E110) 0.4 mg per lozenge. Sucrose 998.925mg per lozenge. Liquid Glucose 50mg per lozenge. _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Lozenge. Round, pale-orange lozenges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the local therapy of most of the common infections of the mouth and oropharynx including: vincents angina, pharyngitis, sore throats, tonsillitis, stomatitis, aphthous ulcers, thrush, glossitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults and children over 10 years: One lozenge to be sucked every 2 to 3 hours, up to a maximum of eight in one day. Elderly: There is no need for dosage reduction in elderly. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The label states: Keep all medicines out of the reach of children. If symptoms persist, consult your doctor. Warning: Do not exceed the stated dose. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/12/2009_ _CRN 2076741_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No clinically significant drug interactions known. 4.6 PREGNANCY AND LACTATION The safety of Dequadin during pregnancy and lactation has not been established, but it is considered a hazard. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No adverse effects known. 4.8 UNDESIRABLE EFFECTS Occasional hypersensitivity reactions and soreness of the tongue are possible. 4.9 OVERDOSE Overdosage sh Preberite celoten dokument