WINDSETLERS - summary of medicine characteristics

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 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

25li 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