Maalox Reflux, Sodium Alginate/Sodium Bicarbonate, 500mg/267mg sugar-free, mint flavour, 12

1. NAME OF DRUG MAALOX REFLUX SODIUM ALGINATE/SODIUM BICARBONATE drinkable sachet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium alginate: 500.00 mg Sodium bicarbonate: 267.00 mg Per 10ml sachet. Dilutants: sodium (6mmol or 138mg per sachet), methyl parahydroxybenzoate (E218) (40mg per sachet), propyl parahydroxybenzoate (E216) (6mg per sachet). To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Drinkable solution in a sachet. Whitish, viscous drinkable solution. 4. CLINICAL DATA 4.1. Therapeutic Indications Treatment for gastro-oesophagian reflux symptoms such as acid regurgitation, pyrosis and difficulty with digestion (linked to reflux), for example after meals or during pregnancy. 4.2. Dosage and how to use Dosage Adults and children over 12 years of age: 1 sachet 3 times per day after the 3 main meals and in the evening before bedtime if necessary. This dosage can be doubled if you have severe oesophagus inflammation or reflux. Elderly: no change in dosage is needed. 4.3. Contraindications This medication should not be taken if you are hypersensitive to the active ingredients or one of its components. 4.4. Special warnings and side effects Patients with a weak gastric acidity will find the effectiveness lower. If there is no improvement after 7 days, consult your doctor. Treatment on childrne younger than 12 is not recommended except from with a medical prescription. This drug contains Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216), and can cause allergic reactions. This drug contains sodium. This medication contains 138mg (6mmol) of sodium per sachet. Patients on a strict low-salt diet should take this into account. 4.5. Interactions with other drugs Anti-acids interact with certain other medication taken orally. Due to the calcium carbonate content which acts as an antacid, a two-hour delay should be considered between taking this medication and the administration of other drugs, especially H2 antihistamines, tetracyclines, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine and diphosphonates 4.6. Pregnancy and breast feeding Pregnancy: There is no clear evidence of malformations detected in animals. The use of this medication among a small number of pregnancies has not caused any malformations or foetal toxicity to this date. However epidemiological studies will allow to rule out this risk. This medication can be prescribed during pregnancy if needed. Breast feeding: This can prescribed during breast-feeding if needed. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Linked to calcium carbonate: - constipation due to the alginate content - prolonged use: hypercalcemia with risk of renal insufficiency and nephrolithiasis Allergic reactions such as urticaria, broncho-spasm and anaphylactic shock. Declaration of suspected side effects The declaration of suspected side effects after drug authorisation is important. It allows continuous observation into the benefits/risks of the drug. Health professionals declare all suspected side effects via the national system of declaration: The ANSM and the network of Regional Centres of Pharmacovigilance- website www.ansm.sante.fr. 4.9. Overdose In case of an overdose, the treatment is symptomatic. Possibility of abdominal pain. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties OTHER MEDICATION FOR ULCERS AND GASTRO-OESPHAGIAN REFLUX. Code ATC: A02BX. The physico-chemical characteristics of the SALIUM SODIUM ALUMINUM / SODIUM MENTHE BICARBONATE MAALOX REFLUX suspension, formed in contact with the acidic gastric liquid, confer on it the following three properties: · Its lightness allows it to float above the gastric contents at the gastroesophageal junction, · Its viscosity and its coherence form a physical barrier which opposes the reflux (decrease of the number of reflux). In severe reflux, the suspension regurgitates first in the oesophagus and is interposed between the oesophageal wall and the irritating gastric fluid. · Its alkaline pH is substituted for the acidic pH of the reflux liquid. Gastric pH metrics showed that administration of MAXOX REFLUX SODIUM ALGINATE / SODIUM MICHEL BICARBONATE increased the pH by 2 units in the cardia but did not alter PH in the rest of the stomach. Its pharmacological efficacy is confirmed by oesophageal pH-metry studies which show that this drug significantly reduces the percentage of overall time spent at acid pH in the oesophagus (pH