מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
BENZOCAINE, CETYLPYRIDINIUM CHLORIDE
SSL Internatinal PLC 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
R02AA
BENZOCAINE 10 mg CETYLPYRIDINIUM CHLORIDE 1.4 mg
LOZENGE
BENZOCAINE 10 mg CETYLPYRIDINIUM CHLORIDE 1.4 mg
OTC
THROAT PREPARATIONS
Withdrawn
2006-12-05
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Merocaine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cetylpyridinium Chloride 1.40mg/lozenge. Benzocaine 10.0mg/lozenge. 3 PHARMACEUTICAL FORM Lozenge. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Merocaine Lozenges provide rapid and profound local anaesthetic action and topical antibacterial effects for the temporary relief of pain and discomfort in sore throat and superficial mouth infections. Indicated for relief of minor throat irritations and adjunctively, for symptomatic relief of pain and discomfort in more serious throat infections, such as tonsillitis and pharyngitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral ADULTS AND CHILDREN OVER 12 YEARS OF AGE: Allow to dissolve slowly in mouth. One lozenge every 2 hours as needed but not more than 8 lozenges in 24 hours. 4.3 CONTRA-INDICATIONS Idiosyncrasy to any of the ingredients and to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE E132 can cause skin sensitivity, a rash similar to nettle rash, itching, nausea, high blood pressure and breathing problems. E104 can cause dermatitis. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. Page 2 of 3 4.6 USE DURING 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 many years without apparent ill- consequence. No data are available on the use of Merocaine lozenges during pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS Allergic reactions and methaemoglobinaemia have been reported with benzocaine. If symptoms persist or קרא את המסמך השלם