WindSetlers

Soft gelatin capsules

4.1 Therapeutic indications Anti-flatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with intestinal gas4.2 Posology and method of administration Oral *Adults, the elderly and children:* One or two capsules taken 3 or 4 times daily or as required for relief4.3 Contraindications Hypersensitivity to any of the ingredients.4.4 Special warnings and precautions for use None stated.4.5 Interaction with other medicinal products and other forms of interaction None reported.4.6 Fertility, pregnancy and lactation 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.4.7 Effects on ability to drive and use machines None stated.4.8 Undesirable effects 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.4.9 Overdose No cases of overdose have been reported. Theoretically, constipation may occur. Treat with fluids and keep under observation.

5.1 Pharmacodynamic properties 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.5.2 Pharmacokinetic properties 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.5.3 Preclinical safety data None stated.

6.1 List of excipients Capsule Shell: Gelatin Glycerin Colour (E142) Quinoline Yellow (E104) Titanium Dioxide (E171) Sodium Ethyl Parahydroxybenzoate (E215) Sodium Propyl Parahydroxybenzoate (E217) Purified Water6.2 Incompatibilities None known.6.3 Shelf life Two years unopened.6.4 Special precautions for storage Store below 25°C in a dry place.6.5 Nature and contents of container 25µ cold formed aluminium blister packs in cardboard cartons in packs of 8 and 24 capsules.6.6 Special precautions for disposal and other handling Not applicable.