Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
Pharmacotherapeutic classification: A02BX, other drugs for peptic ulcer and gastro-oesophageal reflux disease
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 studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing oesophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-oesophageal reflux, for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus, 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 oesophagus from these gastric components
Calcium carbonate neutralises 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. The total neutralising capacity of the product at the lowest dose of two tablets is approximately 10mEqH+.
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
No pre-clinical findings of any relevance to the prescriber have been reported.
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