Sodium alginate 0.5g / Sodium bicarbonate 0.267g, Biogaran, 24 sachets, similar to Gaviscon

1. NAME OF DRUG SODIUM ALGINATE 0.5G / SODIUM BICARBONATE 0.267G drink solution in a sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium alginate .......................................................... 0.5 g Sodium bicarbonate .................................................... 0.267 g Per single-dose sachet. One sachet contains 145mg (6.3 mEq) of sodium and 64.1mg of calcium. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Drinkable solution. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment for gastro-oesophageal reflux. 4.2. Dosage and how to use 1 sachet 3 times per day after each of the 3 main meals and at bedtime if needed. This dosage can be doubled if you are suffering from severe oesophageal reflux/inflammation. Knead the sachet well before opening. 4.3. Contraindications: - Hypersensitivity to one of the ingredients. 4.4. Special warnings and side effects This medication contains 145 mg of sodium per sachet: patients on a strict low-salt diet should take precaution. This drug contains parahydroxybenzoate and can cause local skin reactions ( for example: eczema). 4.5. Interactions with other drugs Antacids interact with certain other drugs taken orally. Precautions of use with other combinations There was a decrease in the digestive absorption of drugs administered simultaneously. For precautionary measures it is not recommended to take anti-acid medication at the same time as other medication. Space out the dose of this medication over 2 hours with: - Antihistamine H2 - Atenolol, metoprolol, propranolol - Chloroquine - Tetracyclines - Diflunisal - Digoxin - Bisphosphonates - Fexofenadine - Iron (salts) - Fluoroquinolones (orally) - Sodium fluoride - Glucocorticoids (described for prednisolone and dexamethasone) - Indomethacin - Kayexalate - Ketoconazole - Lanzoprazole - Phenothiazinic neuroleptics - Penicillamine - Phosphorus (inputs) - Thyroxine Combinations to be aware of: - Aspirin Increase in renal excretion by aspirin by alkalising urine. 4.6. Pregnancy and breast feeding There is no clear evidence of malformations detected in animals. After clinical studies no malformative or foetal toxicity effect has been reported during pregnancies with sodium alginate and sodium bicarbonate. Only epidemiological studies can rule out this risk. This medication can be prescribed during pregnancy if necessary. This medication can be prescribed during breast-feeding if necessary. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Linked to calcium carbonate: - Constipation (exceptional cases linked to the alginate content) - Prolonged use: possible hypercalcemia with risk of nephrolithiasis and renal insufficiency. 4.9. Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: ANTI-REFLUX MEDICATION Code ATC: A02EA. The physicochemical characteristics of SODIUM ALGINATE / SODIUM BIOGARAN BICARBONATE gel, formed in contact with the acidic gastric liquid, give it the following 3 properties: - Its lightness allows it to float above the gastric contents at the gastro-oesophageal junction, - Its viscosity and its coherence form a physical barrier which opposes the reflux (decrease of the number of refluxes). In the case of severe reflux, the gel is regurgitated in the oesophagus and gets between the oesophageal wall and the gastric acid. - Its pH alkaline substitutes the pH liquid acid of the reflux. Gastric pH metrics show that taking this drug increases the pH by 2 units in the cardia but does not change the pH in the rest of the stomach. Its pharmacological efficacy is confirmed by oesophageal pH-metric studies which show that this drug significantly reduces the percentage of overall time spent at acid pH in the oesophagus (pH