Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Glycerol
Reckitt Benckiser Ireland Ltd
R05X
Glycerol
0.25 ml/5ml
Oral solution
Product not subject to medical prescription
OTHER COLD PREPARATIONS
Not marketed
2006-04-07
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING - LABEL 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lemsip Dry Cough 0.25ml/5ml Oral Solution 2. METHOD OF ADMINISTRATION For oral use 3. EXPIRY DATE EXP 4. BATCH NUMBERBN 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25ml/5ml 6. OTHER For the symptomatic relief of dry tickly coughs and sore throats DIRECTIONS HOW MUCH TO TAKE: Adults & Children 12 and over: 2 x 5ml spoonfuls (10ml) per dose, 3 or 4 times daily. Children 1-12 years: 5ml spoonful per dose, 3 or 4 times daily. Do not give to children aged less than 1 year. If you take too much medicine contact your doctor or pharmacist for advice. Symptoms of overdose may include headache, nausea, vomiting, diarrhoea, thirst, dizziness, confusion and palpitations. Erosion of the teeth and mouth irritation is possible with citric acid overdose WARNINGS FOR SAFE USE: KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. If symptoms persist consult your doctor. Do not take this medicine if you are intolerant to sugar. Contains 3.3 g of sucrose and 500 mg invert sugars per 5ml. 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. Warnings: Each 5ml dose contains 0.04mg of ethanol (alcohol). This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free. Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed). Contains benzyl alcohol which may cause allergic reactions. Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Ask your doctor or pharmacist for advice if you are pregnant or breast feeding or have liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). SIDE EFFECTS: Tell your doc Les hele dokumentet
Health Products Regulatory Authority 25 January 2022 CRN00CH35 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lemsip Dry Cough 0.25ml/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml oral solution contains 0.25 ml Glycerol. Excipients with known effects: Sodium 0.83 mg / 5 ml dose. Maximum daily dose (MDD) = 6.64 mg Ethanol 0.05 ml / 5 ml dose (0.04 mg / 5 ml dose) Sucrose 3.3 g / 5 ml dose. Maximum daily dose (MDD) = 26.48 g Invert sugar 500 mg / 5 ml dose. Maximum daily dose (MDD) = 4 g Benzyl Alcohol (trace amounts present in Lemon Oil Terpeneless) Parahydroxybenzoates and their esters (contains sodium ethyl p-hydroxybenzoate (E215), sodium propyl p-hydroxybenzoate and sodium methyl p-hydroxybenzoate (E219) For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear yellow solution, with characteristic lemon odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of dry tickly coughs and sore throats. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms and a healthcare professional should be consulted if symptoms persist or worsen. ADULTS AND CHILDREN OVER 12: Two 5ml spoonfuls, three or four times daily. CHILDREN 1-12 YEARS: One 5ml spoonful, three or four times daily. CHILDREN AGED LESS THAN 1 YEAR: Not suitable (see section 4.3) No special dose is required for elderly patients. METHOD OF ADMINISTRATION: Oral 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or any of the excipients listed in section 6.1 Do not give to children under 1 year. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Citrates should not be taken together with aluminium hydroxide or aluminium-containing antacids in patients with end-stage renal disease unless consulted with healthcare professional (see section 4.5) Health Products Regulatory Authority 25 January 2022 CRN00CH35 Page 2 of 4 This medicine contains less than Les hele dokumentet