Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Dendron Brands Limited, 94, Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ, United Kingdom
Excessive swallowing of air results in collection of gas in the intestine. This can be the result of too rapid eating, excessive use of a pacifier (dummy), finger sucking or yelling. When the swallowed air is in the intestine, bubbles are formed, which makes it more difficult for the gas to pass through the intestine canal, resulting in abdominal distension and pain. Activated Dimeticone is a surface active substance which changes the surface tension of the intestinal mucus. Thus, the air bubbles burst and the gas is released. The elimination of the gas, air or foam from the gastro-intestinal tract, relieves abdominal distension and dyspepsia.
Activated Dimeticone is chemically inert and is not absorbed. Its effect is local on the intestinal contents.
No side effects from the substance are reported from the literature.
From the toxicity trials undertaken by Dow Corning, it has been demonstrated in the rat that all the Dimeticone was recovered in the faeces and that there was no increase in urinary salicate output.
In four human subjects given 376.5mg of Activated Dimeticone, twice daily for 10 days, it was found that there was no increase in their urinary silicate output and no evidence of absorption of the silicone.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
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