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 hydroxybenzoate (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 Interaction 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

As dimeticone is not absorbed from the gastro-intestinal tract, adverse effects attributable to the active ingredient would not be expected.

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, 24 and 30 capsules or glass bottles of 24, 30 or 60 capsules.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

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

16/10/2008

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable