Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
CETYLPYRIDINIUM CHLORIDE BENZOCAINE
SSL International plc
1.4mg/10.0 Milligram
Lozenges
2006-04-28
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Merocaine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1. 3 PHARMACEUTICAL FORM Lozenge Clear green, slightly domed shaped, disc lozenge with a lemon-lime flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct for the relief of pain and discomfort in the oral cavity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OVER 12 YEARS Allow to dissolve slowly in the mouth. One lozenge every 2 hours as needed but not more than 8 lozenges in 24 hours. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist, or are severe, or are accompanied by fever, headache, nausea and vomiting 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 or benzocaine in human pregnancy but they have been in wide use for manyyears without apparent ill consequence. No data are available on the use of Merocaine lozenges during pregnancy and lactation. Cetylpyridinium chloride 1.4 mg/lozenge Benzocaine 10.0 mg/lozenge IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/07/2006_ _CRN 2025805_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS This product may give rise to allergic reactions, methaemoglobinaemia, and sensitisation may also develop. 4.9 OVERDOSE There is no experience of overdosage but normal procedures of gastric lavage and maintenance of respiration and circulation (using vasopressor drugs if necessary) should a Belgenin tamamını okuyun