Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Cetylpyridinium chloride; Benzocaine
Sanofi-Aventis Ireland Limited T/A SANOFI
R02AA; R02AA06
Cetylpyridinium chloride; Benzocaine
1.4mg/ 10 milligram(s)
Lozenge
Product not subject to medical prescription
Antiseptics; cetylpyridinium
Not marketed
1982-03-10
MEROCAINE LOZENGES Benzocaine 10mg and Cetylpyridinium chloride 1.4mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STARTING TAKING MEROCAINE LOZENGES BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take Merocaine lozenges exactly as described in this leaflet or as your pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after three days. 1. WHAT MEROCAINE LOZENGES ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEROCAINE LOZENGES 3. HOW TO TAKE MEROCAINE LOZENGES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MEROCAINE LOZENGES 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT MEROCAINE LOZENGES ARE AND WHAT THEY ARE USED FOR These lozenges contain benzocaine and cetylpyridinium chloride and are for the temporary relief of pain and discomfort in sore throats and superficial mouth infections. It is also used for symptomatic relief of pain and discomfort in more serious throat infections such as tonsillitis and pharyngitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEROCAINE LOZENGES DO NOT TAKE MEROCAINE LOZENGES • If you are allergic to any of the ingredients in this product listed in section 6. See ‘Contents of the pack and other information’ for the full list of ingredients • If you have been told by your doctor that you have an intolerance to some sugars. The product contains 1.37g sucrose per dose and 1.0496g glucose per dose. This should be taken into account in patients with diabetes mellitus. WARNINGS AND PRECAUTIONS Use of this product may cause methaemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention i Lugege kogu dokumenti
Health Products Regulatory Authority 18 October 2019 CRN008WWD Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Merocaine Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cetylpyridinium chloride 1.4 mg/lozenge Benzocaine 10.0 mg/lozenge Excipients with a known effect: also includes sucrose 1.137g per lozenge and glucose 1.0496g per lozenge. For a full list of excipients, see section 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 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 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. CHILDREN UNDER 12 YEARS Merocaine lozenges are not recommended for use in children under 12 years (see section 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredients or any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Consult your doctor in case of severe irritation of your throat with high fever or if symptoms persist for more than 3 days. Merocaine Lozenges contain sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. This should be taken into account in patients with diabetes mellitus. Cases of methaemoglobinaemia have been reported with Merocaine Lozenges (see section 4.8). If patients present with signs or symptoms of methemoglobinemia such as pale, grey or blue coloured skin, lips and nail beds; headache; Lugege kogu dokumenti