Wind-eze Gel Caps

1. Name Of The Medicinal Product

Wind-eze Gel Caps

2. Qualitative And Quantitative Composition

Each soft capsule contains: 125mg Simeticone (activated dimeticone)

For excipients see 6.1

3. Pharmaceutical Form

Capsule, soft.

The capsules are oval gelatin capsules with a white to off white opaque gelatin shell.

4. Clinical Particulars

4.1 Therapeutic Indications

The symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with gastrointestinal gas.

4.2 Posology And Method Of Administration

For oral administration:

Adults, children (12 years and above) and elderly:

One gel capsule to be taken three or four times daily or as required for relief, after meals and upon retiring.

Not recommended for children under 12 years of age.

4.3 Contraindications

The product should not be used in patients with known hypersensitivity to simeticone or to any excipients of the medicinal product.

4.4 Special Warnings And Precautions For Use

If symptoms persist or worsen, the patient should consult their medical practitioner for further investigation.

This medicinal product contains glycerol. Harmful in high doses. Can cause headache and can cause stomach upset and diarrhoea.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Although no studies have been presented, the concomitant use of this drug and mineral oil (paraffin) based laxatives is not recommended since mixing of these two will diminish the efficacy.

4.6 Pregnancy And Lactation

As thus far known, this drug can be used during pregnancy in compliance with the prescription, without any further restriction.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Minor adverse effects: nausea and constipation. Rarely hypersensitivity reactions such as rash, pruritis, facial oedema, tongue oedema, respiratory difficulty.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Simeticone is an anti-flatulent with ATC code A03AX13. Physiologically simeticone is extremely inert, and therefore it will not be pharmacologically active. It acts by changing the surface tension of gas bubbles, causing them to coalesce.

5.2 Pharmacokinetic Properties

Simeticone is not absorbed following oral administration.

5.3 Preclinical Safety Data

Simeticone is physiologically inert and considered to be non-toxic. Preclinical data reveal no hazard for humans.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Capsule shell:

Gelatin

Glycerol

Titanium Dioxide (E171)

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister packs of construction PVDC/PVC and aluminium foil with heat sealing coat.

Pack sizes: 10, 20, 30, 50 and 60.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

Stafford-Miller Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS UK

Trading as :

GlaxoSmithKline Consumer Healthcare

Brentford,

TW8 9GS.

UK

8. Marketing Authorisation Number(S)

PL 00036/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

16 June 1997

10. Date Of Revision Of The Text

August 2006