Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CETYLPYRIDINIUM CHLORIDE
SSL International plc
Lozenges
2006-03-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Merocets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Cetylpyridinium chloride 1.40 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Lozenges Round, yellow, plain, convex lozenges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic for the symptomatic relief of sore throat. Also indicated for the minor irritations of the mouth and throat. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One lozenge every 3 hours. Allow the lozenge to dissolve slowly in the mouth. For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient cetylpyridinium chloride. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Label: If sore throat persists, consult your doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION There is no or inadequate evidence of safety of cetylpyridinium chloride in human pregnancy but it has been in wide use for many years without apparent ill-consequences. No data are available on the use of Merocets in pregnancy. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/07/2006_ _CRN 2025803_ _page number: 1_ 4.8 UNDESIRABLE EFFECTS Very rare reports of urticaria. Infrequent and transient complaints of a burning sensation of the mouth. 4.9 OVERDOSE No experience of overdosage but normal procedures of gastric lavage and maintenance of respiration and circulation (using vasopressor drugs if necessary) should apply. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Cetylpyridinium chloride is a surface active quaternary ammonium compound with an Read the complete document