Wind-Eze Tablets

1. Name Of The Medicinal Product

Wind-Eze

2. Qualitative And Quantitative Composition

Simeticone [Equivalent to Poly(Dimethylsiloxane)], 11.57% w/w, approx. 125.00mg

3. Pharmaceutical Form

Chewable tablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Antiflatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other similar symptoms associated with gastrointestinal gas.

4.2 Posology And Method Of Administration

Adults, elderly and children over 12 years:

One tablet to be taken three or four times daily or as required for relief, after meals and upon retiring. The tablets are to be chewed before swallowing.

Not recommended for children under 12 years.

4.3 Contraindications

The product should not be used in patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

If symptoms persist or worsen, medical advice should be sought.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Since simeticone is not absorbed by the gastro intestinal tract, Wind-Eze may be taken during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely hypersensitivity reactions such as rash, pruritus, facial oedema, tongue oedema, respiratory difficulty.

4.9 Overdose

In the unlikely event of deliberate or accidental overdosage, treat symptoms on appearance. There are no special procedures recommended.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Physiologically simeticone is extremely inert, and therefore it will not be pharmacologically active.

5.2 Pharmacokinetic Properties

Simeticone (activated dimeticone) is not absorbed following oral administration. It acts by changing the surface tension of gas bubbles, causing them to coalesce.

5.3 Preclinical Safety Data

Simeticone is physiologically inert and considered to be non-toxic. It is not absorbed following oral administration, nor is it pharmacologically active. Preclinical data reveal no hazard for humans.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dextrates (hydrated) USNF

Sorbitol Crystalline EP

Tribasic Calcium Phosphate (Powder) USNF

Citric Acid Anhydrous (Powder) EP

Natural and artificial peppermint flavour No. 517

(Spray dried) HSE

Talc (purified) EP

Non-pareil seeds (Starch/Sucrose) HSE

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years in PVC/PVDC Al foil blister packs. 3 years in PVC/PE/Aclar Al. foil blister packs.

6.4 Special Precautions For Storage

Store below 25^oC.

Store in a dry place.

6.5 Nature And Contents Of Container

Blister packs of construction 190 μm PVC (product contact side)/51μm PE/38μm aclar and 25μm aluminium foil with vinyl sealing coat (product contact side).

or

Blister packs of construction 250μm PVC (product contact side)/PVDC 60 g/m² and 20 μm aluminium foil with vinyl heat sealing coat (product contact side).

Pack sizes: 4, 10, 20, 30, 50.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Stafford-Miller Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as GlaxoSmithKline Consumer Healthcare, Brentford TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00036/0084

9. Date Of First Authorisation/Renewal Of The Authorisation

25th May 2001

10. Date Of Revision Of The Text

February 2008