Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
AMMONIUM CHLORIDE, IPECACUANHA FLUID EXTRACT, CITRUS LIMON, HONEY, LIQUID GLUCOSE
Forest Laboratories UK Ltd
R05CA04
AMMONIUM CHLORIDE, IPECACUANHA FLUID EXTRACT, CITRUS LIMON, HONEY, LIQUID GLUCOSE
%v/v
Oral Solution
Product not subject to medical prescription
Expectorants
Authorised
2011-12-21
1 . WHAT VENO’S HONEY & LEMON IS USED FOR? This cough mixture has been specially formulated to ✓ relieve dry, tickly or scratchy coughs ✓ soothe and protect sore, irritated throats It can be given to both adults and children over 12 years. 2 . BEFORE YOU TAKE VENO’S HONEY & LEMON DO NOT TAKE VENO’S HONEY & LEMON • if you are allergic to any of the ingredients listed in Section 6. • if you are taking any other cough and cold medicine. • if symptoms persist consult your doctor. DO NOT GIVE VENO’S HONEY & LEMON • to children under 12 years of age. TAKE SPECIAL CARE WITH VENO’S HONEY & LEMON • this medicinal product contains less than 1mmol sodium (23mg) per 15ml dose, i.e. essentially 'sodium free'. • Prolonged use should be avoided. If the symptoms persist medical advice should be sought. VENO’S HONEY AND LEMON CONTAINS GLUCOSE AND FRUCTOSE Contains a total quantity of 4.5g of sugars per 5 ml which equates to 13.5 g per 15 ml dose. This should be taken into account in patients with diabetes mellitus If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May have a mild laxative effect. Calorific value 2.3 kcal/g hydrogenated glucose syrup. VENOS HONEY & LEMON CONTAINS SODIUM METABISULPHITE (E233): • sodium metabisulphite (E223) - may rarely cause severe allergic reactions and breathing difficulty with any other cough and cold medicine. PREGNANCY AND BREASTFEEDING • if you are pregnant or breastfeeding consult your doctor. 3 . HOW TO TAKE VENO’S HONEY & LEMON FOR ORAL USE. SHAKE THE BOTTLE BEFORE USE. ADULTS, ELDERLY AND CHILDREN 12 YEARS AND OVER: Fill measure cup to 15ml mark and take one 15ml dose (three 5ml spoonfuls). Repeat every 2-3 hours. Do not exceed 8 doses in 24 hours. Do not take with any other cough and cold medicine. DO NOT GIVE TO CHILDREN UNDER 12 YEARS OF AGE. For professional advice on medicines consult your pharmacist. DRIVING AND USING MACHINES Because Veno’s Honey & Lemon is Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Veno’s Honey and Lemon oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml dose contains lemon Juice 1.0ml, Honey 250 mg, Ammonium Chloride Ph. Eur. 30 mg, Ipecacuanha Liquid Extract BP 3.0 microlitres and Liquid Glucose Ph.Eur. 4.0g. Excipients with known effects: Each 5ml dose contains 2.5mg sodium metabisulphite. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution A gold coloured, viscous clear syrup, with a lemon and honey flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of productive cough, in adults and children over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and Children aged 12 years and over:_ Fill measure cup to 15 ml mark (three 5 ml spoonfuls) and repeat every 2 to 3 hours. Do not exceed 8 doses in any 24 hours. _Elderly population:_ The normal adult dose may be taken. _Paediatric population:_ The safety and efficacy in children under 12 years of age have not been established. Method of administration For oral administration. Shake the bottle before use. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the active ingredients or to any of the excipients listed in section 6.1. Children under 12 years of age. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _7_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _7_ _7_ _3_ _7_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 Læs hele dokumentet