البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
DOMIPHEN BROMIDE LIDOCAINE HYDROCHLORIDE
Novartis Consumer Health UK Limited
DOMIPHEN BROMIDE LIDOCAINE HYDROCHLORIDE
0.5mg/5mg Per Cent
Lozenges
Withdrawn
2006-11-22
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bradosol Plus Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains: Domiphen Bromide 0.5 mg Lidocaine Hydrochloride 5.0 mg For excipients, see 6.1. 3 PHARMACEUTICAL FORM A bright green, flat-biconvex cylindrical lozenge. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct in the management of superficial infections of the mouth and oropharynx. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults and Children over 12 years only: One lozenge to be sucked every 2-3 hours as required A maximum number of 8 lozenges per day should not be exceeded Method of administration: Oromucosal use 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active ingredients. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE The local anaesthetic may affect swallowing reflexes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 PREGNANCY AND LACTATION No information given. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 30/08/2005_ _CRN 2014252_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS This product may give rise to allergic reactions, sensitisation may also develop. 4.9 OVERDOSE No information given. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Antiseptic/local anaesthetic combination lozenge. 5.2 PHARMACOKINETIC PROPERTIES No information given. 5.3 PRECLINICAL SAFETY DATA No information given. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Citric acid monohydrate Menthol Eucalyptus oil Quinoline yellow (E104) Indigo carmine (E132) Acesulfame Potassium Isomalt 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE 1 year. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not sto اقرأ الوثيقة كاملة