Summary of Product Characteristics (SmPC) - Windsetlers
1 NAME OF THE MEDICINAL PRODUCT
WindSetlers.
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
Oral
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. Interactions with other medicinal products and other forms of interaction
None reported.
4.6. 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. 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:
Gelatin
Glycerin
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. Instruction for use and handling and disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00240/0095
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 March 2003
10 DATE OF REVISION OF THE TEXT
10/10/2018