Sodium alginate, calcium carbonate, sodium bicarbonate.
Each sachet (10ml) contains: Sodium Alginate 500mg, Calcium Carbonate 325mg, Sodium Bicarbonate 213mg, Methyl Parahydroxybenzoate (preservative) 28mg, Propyl Parahydroxybenzoate (preservative) 4mg.
Pharmacotherapeutic Group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease.
Pharmacology: Pharmacodynamics: The medicinal 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 which floats on the stomach contents effectively impeding gastro-oesophageal reflux, for up to 4 hours.
In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.
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 neutralising action.
Pharmacokinetics: The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, and for symptoms of excess stomach acid (hyperacidity).
Recommended Dose: Adults and children aged 12 and above: 1 to 2 sachets after meals and before bedtime.
Mode of Administration: For oral administration.
Symptoms and Treatment of Overdose: In the event of overdose symptomatic treatment should be given. The patient may notice abdominal distension.
Hypersensitivity, including the esters of hydroxybenzoates (parabens).
Each 10ml (single sachet) dose has a sodium content of 127.9mg (5.56mmol). 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 10ml (single sachet) dose contains 130mg (3.25mmol) of calcium.
Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxy-benzoate (E216) which may cause allergic reactions (possibly delayed).
There is no significant adverse effects of the product known on the course of pregnancy or on the health of the foetus/new-born child. The medicinal product may be used during pregnancy and lactation.
Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
Ingestion of large quantities of calcium carbonate may cause alkalosis, hypercalcaemia, acid rebound, milk alkali syndrome or constipation. These usually occur following larger than recommended dosages.
Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2 hours should be considered between the medicinal product intake and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, and diphosphonates.
Store at temperature below 30°C. Protect from direct sunlight and moisture.
Shelf-Life: 2 years from the date of manufacture.
A02BX - Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) ; Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Oral susp 10 mL (peppermint-flavoured, pale yellow or cream-coloured contained in aluminium foil pouch) x 24's.