Fluisédal – Meglumine 2.6g Wet Cough Syrup (Ages 2+) – 125ml Vial

1. Ingredients Per 100ml: Meglumine benzoate – of which anhydrous phloroglucinol: 2.600 g Polysorbate 20 – 0.300 g – 1 teaspoon contains 3.6 g of sucrose. – 1 soup spoon contains 10.8 g of sucrose. For a full list of excipients, see section 3.1. 2. Product Information 2.1. Therapeutic IndicationsTo supplement treatment of bronchial blockages. 2.2. Directions for Use and Dosage– Adults and children over 12 years: Take 2 to 4 soup spoons a day. – Children 6 to 12 years: Take 4 to 8 teaspoons a day. – Children 30 months to 6 years: Take 3 to 4 teaspoons a day. – Children 24 to 30 months : Take 1 to 3 teaspoons a day. 2.3. Contra-indicationsDo NOT: – use if you are allergic to any of this medicine's ingredients; or – give to children under 2 years (see above). You are advised not to use this medicine during pregnancy (see below). 2.4. Precautions and WarningsWarnings – Productive cough is one of the respiratory system's basic defences and must not be inhibited. – Bronchial mucus modifiers should not be combined with cough medicines and/or substances formulated to dry out bronchial secretions. – In very young children, mucolytics can further block the bronchi – certain characteristics of the respiratory tract that are unique to newborn babies can inhibit bronchial drainage. For this reason, mucolytics should not be given to very young children. – If symptoms persist, your condition deteriorates or you develop an infection, your treatment will need to be re-evaluated. – Contains sucrose. Do not use if you are fructose-intolerant or have glucose-galactose malabsorption or a sucrase-isomaltase deficiency. Precautions for Use – Use with caution if you have a peptic ulcer. – If you are diabetic or otherwise on a low-sugar diet, note that this medicine contains 3.6 g of sucrose per teaspoon (or 10.8 g per soup spoon). 2.5. Interactions with Other MedicinesNo clinically significant interactions based on data currently available. 2.6. Pregnancy and Breast-Feeding– No reliable data exists concerning the possibility of teratogenesis in animals. – Currently, there is no relevant data (or a lack thereof) on which to evaluate the possible malformative or fœtotoxic effects of meglumine benzoate in pregnant women. Therefore, you are advised not to take this medicine during pregnancy. – You are advised not to use this medicine if you are breast-feeding. 2.7. Driving and Operating MachineryThis medicine is not believed to impair your ability to drive or operate machinery safely. 2.8. Possible Side EffectsRisk of further bronchial blockage, particularly in very young children and those with poor expectoration (see above). 2.9. Excessive DoseExcessive dose may cause additional bronchial blockage (see above). 3. Pharmacodynamic Properties – Pharmacotherapeutic Group: Mucolytics (R: Respiratory System) 4. Pharmaceutical Information 4.1. ExcipientsCaramel colour (E150)*, sucrose, caramel flavour**, purified water *(Glucose, ammonia) **(Vanillin, piperonal, gamma-nonalactone, maltol, acetyl methyl carbinol, propylene glycol) 4.2. Shelf Life3 years 4.3. Storage InstructionsStore below 25°C and away from light. 4.4. Packaging125ml or 250ml vial (type III glass with polyethylene cap) 5. Marketing Authorisation Holder LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE 181-183 RUE ANDRE KARMAN 93303 AUBERVILLIERS CEDEX FRANCE 6. Marketing Authorisation No. – 320 609-6: 125ml vial (glass) – 331 477-9: 250ml vial (glass) 7. Prescription and Delivery Conditions Non-prescription medicine