Advanced search

Report side effect

Report a suspected side effect or falsified product to the MHRA Yellow Card scheme.
Go to {yellow_card_logo} site
{arrow_up} Back to top


Active Ingredient:
Thornton & Ross Ltd See contact details
About Medicine
{healthcare_pro_orange} This information is for use by healthcare professionals
Last updated on emc: 24 Oct 2018
1. Name of the medicinal product


2. Qualitative and quantitative composition

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

3. Pharmaceutical form

Soft gelatin capsules

4. Clinical particulars
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 gas

4.2 Posology and method of administration


Adults, the elderly and children:

One or two capsules taken 3 or 4 times daily or as required for relief

4.3 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 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. Pharmacological properties
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. Pharmaceutical particulars
6.1 List of excipients

Capsule Shell:



Colour (E142)

Quinoline Yellow (E104)

Titanium Dioxide (E171)

Sodium Ethyl Parahydroxybenzoate (E215)

Sodium Propyl Parahydroxybenzoate (E217)

Purified Water

6.2 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.

7. Marketing authorisation holder

Thornton & Ross Limited



West Yorkshire


United Kingdom

8. Marketing authorisation number(s)

PL 00240/0095

9. Date of first authorisation/renewal of the authorisation

1 March 2003

10. Date of revision of the text


Thornton & Ross Ltd
Company image
Linthwaite, Huddersfield, West Yorks, HD7 5QH
Medical Information Direct Line
+44 (0) 1484 848164
Medical Information e-mail
[email protected]
Customer Care direct line
+44(0)1484 848200