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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 25oC.
Store in a dry place.
6.5 Nature And Contents Of Container
Blister packs of construction 190 ?m PVC (product contact side)/51?m PE/38?m aclar and 25?m aluminium foil with vinyl sealing coat (product contact side).
or
Blister packs of construction 250?m PVC (product contact side)/PVDC 60 g/m2 and 20 ?m 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
Wind Eze Tablets
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