País: Malta
Idioma: anglès
Font: Medicines Authority
DEQUALINIUM CHLORIDE
Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom
R02AA02
DEQUALINIUM CHLORIDE 0.25 mg
LOZENGE
DEQUALINIUM CHLORIDE 0.25 mg
OTC
THROAT PREPARATIONS
Withdrawn
2008-07-07
------------------------- DOCUMENT OUTLINE * m1-3-1-label-revised.pdf [/PIL_MA190_00101.html#1] * Pages from RB002337-20s-UK-rv2.pdf [/PIL_MA190_00101.html#1] * m1-3-1-label-revised.pdf * foil.pdf [/PIL_MA190_00101.html#4] * dequadin 40s.pdf [/PIL_MA190_00101.html#3] Llegiu el document complet
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Dequadin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 0.25 mg dequalinium chloride BP 3. PHARMACEUTICAL FORM Lozenge 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the local therapy of most of the common infections of the mouth 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 a dosage reduction in the elderly. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND SPECIAL 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. 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION No clinically significant drug interactions known. Page 2 of 3 4.6 PREGNANCY AND LACTATION The safety of Dequadin during pregnancy and lactation has not been established, but it is not considered to constitute 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 should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic. 5. PHARMACOLOGICAL PARTICULARS 5.1 PHARMACODYNAMIC PROPERTIES Dequalinium chloride is a quaternary ammonium antiseptic active against many gram-positive and gram-negative bacteria, yeasts and fungi. 5.2 PHARMACOKINETI Llegiu el document complet