GSL: General Sales Licence
This information is intended for use by health professionals
Each Capsules contains simeticone 100mg
Also contains sodium ethyl parahydroxybenzoate (E215) and sodium propyl parahydroxybenzoate (E217)
For full list of excipients, see section 6.1
Soft gelatin capsules
Anti-flatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with intestinal gas
Adults, the elderly and children:
One or two capsules taken 3 or 4 times daily or as required for relief
Hypersensitivity to any of the ingredients.
As dimeticone is not absorbed, it is not anticipated that WindSetlers will have any adverse effects on pregnancy and lactation. However, as with all drugs, caution should be exercised in these conditions.
Minor adverse effects: nausea and constipation.
Rarely, hypersensitivity reactions such as rash, pruritis, facial oedema, tongue oedema and respiratory difficulty have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.
No cases of overdose have been reported. Theoretically, constipation may occur. Treat with fluids and keep under observation.
WindSetlers contain activated dimeticone, a chemically inert gastric defoaming agent which alters the elasticity of interfaces of mucous-embedded bubbles in the gastro-intestinal tract. The gas bubbles are thus broken or coalesced and in this form, the gas is more easily eliminated through belching or passing flatus.
Activated dimeticone is not absorbed from the gastrointestinal tract and does not interfere with gastric secretion or absorption of nutrients. Following oral administration, it is excreted unchanged in the faeces.
Quinoline Yellow (E104)
Titanium Dioxide (E171)
Sodium Ethyl Parahydroxybenzoate (E215)
Sodium Propyl Parahydroxybenzoate (E217)
Two years unopened.
Store below 25°C in a dry place.
25µ cold formed aluminium blister packs in cardboard cartons in packs of 8 and 24 capsules.
Thornton & Ross Limited
1 March 2003