Sodium alginate 500 mg/ - Sodium bicarbonate 267mg - Biogaran - 12 dose sachets

1. NAME OF THE MEDICINAL PRODUCT

SODIUM ALGINATE/BICARBONATE BIOGARAN 500 mg/267 mg, Oral suspension in sachet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium alginate .......................................................... 0.5 g

Sodium bicarbonate ................................................... 0.267 g For one sachet.

One sachet contains 145 mg (6.3 mEq) sodium and 64.1 mg calcium. For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Drinkable suspension.

4. CLINICAL DATA

4.1 Therapeutic indications

Symptomatic treatment of gastro-oesophageal reflux disease.

4.2. Dosage and administration 1 sachet 3 times daily, after the 3 main meals and possibly in the evening, at bedtime. This dose may be doubled in cases of severe reflux or oesophageal inflammation. Knead the sachet well before opening.

4.3. Contraindications

- Hypersensitivity to any of the components of the oral suspension.

4.4 Special warnings and precautions for use

This medicine contains 145 mg of sodium per sachet: this should be taken into account by people on a strict low-salt diet.

This medicine contains ‘parahydroxybenzoate’ and may cause allergic reactions (which may be delayed).

4.5. Interactions with other medicinal products and other forms of interaction

Antacids interact with certain other orally-absorbed medicinal products. Combinations subject to precautions for use

The digestive absorption of concomitantly administered drugs is reduced. As a precaution, antacids should be taken at a distance from other medicines. If possible, take this medicine at least 2 hours apart from other medicines: + H2 antihistamines + Atenolol, metoprolol, propranolol + Chloroquine + Cyclines + Diflunisal + Digoxin + Bisphosphonates + Fexofenadine + Iron (salts) + Fluoroquinolones (oral) + Sodium fluoride + Glucocorticoids (described for prednisolone and dexamethasone) + Indometacin + Kayexalate + Ketoconazole + Lanzoprazole + Phenothiazine neuroleptics + Penicillamine + Phosphorus (intake) + Thyroxine Associations to be taken into account + Acetylsalicylic acid: Increased renal excretion of aspirin by alkalinisation of the urine

4.6. Pregnancy and lactation

There are no reliable data on teratogenesis in animals. Clinically, analysis of a large number of exposed pregnancies has apparently not revealed any particular malformative or foetotoxic effect of SODIUM ALGINATE / SODIUM BICARBONATE BIOGARAN. However, the absence of risk can only be verified by epidemiological studies. Consequently, this medicine may be prescribed during pregnancy if necessary. This medicinal product may be prescribed during breast-feeding, if necessary.

4.7. Effects on ability to drive vehicles and use machines Not applicable.

4.8. Undesirable effects Linked to calcium carbonate: - Possible constipation, which is exceptional due to the presence of alginate. - With prolonged use, hypercalcaemia may occur, with a risk of nephrolithiasis and renal failure. 

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties Pharmacotherapeutic class: ANTI-REFLUX DRUGS, ATC Code: A02EA.

The physico-chemical characteristics of BIOGARAN SODIUM ALGINATE / SODIUM BICARBONATE gel, formed on contact with acidic gastric fluid, give it the following 3 properties:

- its lightness allows it to float above the gastric contents at the gastro-oesophageal junction,

- In the event of severe reflux, the gel is regurgitated first into the oesophagus and interposed between the oesophageal wall and the irritating gastric fluid,

- its alkaline pH replaces the acidic pH of the reflux fluid. Gastric pH-metry shows that administration of this drug increases the pH by 2 units in the cardia but does not alter the pH in the rest of the stomach. Its pharmacological efficacy has been confirmed by oesophageal pH-metry studies, which show that this drug significantly reduces the overall percentage of time spent at acid pH in the oesophagus (pH < 4), as well as the number and average duration of reflux episodes.

The efficacy of this medicine on reflux symptoms has been demonstrated in patients with previously healed grade I or II oesophagitis.

5.2. Pharmacokinetic properties SODIUM ALGINATE / SODIUM BICARBONATE BIOGARAN is immediately transformed in the stomach on contact with the acidic liquid into a light foaming gel (release of carbon dioxide bubbles), viscous (alginate precipitate), with a pH close to neutral. This gel persists for a long time (2 to 4 hours) in the upper part of the stomach and is evacuated as the stomach empties. It does not affect transit. The alginates (non-absorbable polysaccharides) are completely eliminated via the digestive tract. 

6. PHARMACEUTICAL DATA

6.1. List of excipients Calcium carbonate, carbomer (carbopol 974 P-NF), sodium hydroxide, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint essential oil (limonene, cineole, menthone, menthofuran, isomenthone, menthyl acetate, isopulegol, menthol, pulegone, piperitone, carvone), purified water.

6.2 Incompatibilities Not applicable.

6.3. Shelf life 2 years.

6.4. Special precautions for storage Store at a temperature not exceeding 25°C.

6.5. Nature and contents of packaging 10 ml dose sachet (PE/Aluminium/Paper). Box of 24.

6.6. Special precautions for disposal and handling No special requirements.