Generics: Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate
Dosage Form: Suspension.
This preparation is indicated in Gastric reflux, Heartburn, Flatulence associated with gastric reflux, Heartburn of pregnancy, All cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
The mode of action of the product is physical and does not depend on absorption into the systemic circulation. The product is a combination of two antacids (Calcium Carbonate and Sodium Bicarbonate) and an Alginate. On ingestion, the medicinal product reacts rapidly with gastric acid to form a raft of Alginic Acid gel having a near neutral pH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing esophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-esophageal reflux, for up to 4 hours, and protecting the esophagus from Acid, Pepsin and Bile.In severe cases the raft itself may be refluxed into the esophagus, in preference to the stomach contents, and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the esophagus from these gastric components. Calcium Carbonate neutralizes gastric acid to provide fast relief from indigestion and heartburn.This effect is increased by the addition of Sodium Bicarbonate which also has a neutralizing action.
Dosage guideline: Once Daily.
- Adult and children over 12 years:10-20 mL after meals and at bedtime, up to four times a day.
- Children 6 to 12 years: 5-10 mL after meals and at bedtime, up to four times a day.
- Children under 6 years: Not recommended.
- Elderly: No dose modifications necessary.
- Hepatic Impairment: No dose modification necessary.
- Renal Insufficiency: Caution if highly restricted salt diet is necessary.
Route of administration: Orally.
A time-interval of 2 hours should be considered between this drug intake and the administration of other medicinal products, especially Tetracyclines, Digoxine, Fluoroquinolone, Iron salt, Ketoconazole, Neuroleptics, Thyroid Hormones, Penicillamine, beta-blockers (Atenolol, Metoprolol, Propranolol), Glucocorticoid, Chloroquine and Biphosphonates (diphosphonates) and Estramustine.
This product is contraindicated in patients with known or suspected hypersensitivity to the active ingredients or to any of the excipients.
In addition to the desired effect of the drug, some side effects may appear such as: constipation, flatulence, stomach cramp or belching. In these cases consult a physician. If too big dose has been taken, there might appear a sensation of swelling. In this case, it is advisable to consult a physician.
Pregnancy & Lactation:
Pregnancy: Clinical studies in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate no malformative nor feto/neonatal toxicity of the active ingredients. This drug can be used during pregnancy, if clinically needed.
Breastfeeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This drug can be used during breastfeeding.
Fertility: Pre-clinical investigations have revealed Alginate has no negative effect on parental or offspring fertility or reproduction. Clinical data do not suggest that this drug has an effect on human fertility.
Precautions & Warnings:
If symptoms do not improve after 7 days, the clinical situation should be reviewed. Each 10 mL dose has a Sodium content of 141 mg (6.2 mmoL). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment. Each 10 mL dose contains 160 mg (1.6 mmoL) of Calcium Carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children. Do not refrigerate or freeze.
Manufactured by: Incepta Pharmaceuticals Ltd.