מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL
Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom
R02AA20
AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL
LOZENGE
AMYLMETACRESOL 0.6 milligram(s) ; 2,4 DICHLOROBENZYL ALCOHOL 1.2 milligram(s)
OTC
THROAT PREPARATIONS
Authorised
2006-02-28
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Honey and Lemon 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amylmetacresol BP 0.6mg 2,4-Dichlorobenzyl alcohol 1.2mg For excipients, see 6.1 3 PHARMACEUTICAL FORM A yellow circular lozenge 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of mouth and throat infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults and children (over 6 years old): One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours. Not suitable for children under 6 years. Page 2 of 6 Elderly: There is no need for dosage reduction in the elderly. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Keep all medicines out of the reach of children. If symptoms persist consult your doctor. 4.4 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No clinically significant interactions are known. 4.5 PREGNANCY AND LACTATION The safety of Strepsils Honey and Lemon during pregnancy and lactation has not been established, but it is not considered to constitute a hazard during these periods. 4.6 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No adverse effects are known. 4.7 UNDESIRABLE EFFECTS Occasionally hypersensitivity reactions. 4.8 OVERDOSE Overdosage should not present a problem other than gastrointestinal discomfort. Page 3 of 6 Treatment should be symptomatic. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES PHARMACOTHERAPEUTIC GROUP: Throat Preparations; Antiseptics; ATC CODE: R02AA03 Dichlorobenzyl alcohol. 2,4-dichlorobenzyl alcohol and amylmetacresol are antiseptics and possess antibacterial (bactericidal and bacteriostatic), antifungal and antiviral properties. Both AMC and DCBA also reversibly block depolarisation-induced ion channels in a similar way to local anaesthetics. When the two active agents are combined, a synergistic antibacterial action is observe קרא את המסמך השלם