WIND-EZE

Active substance: SIMETICONE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

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 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
No special requirements.

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 00036/0305

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/08/2010

10

DATE OF REVISION OF THE TEXT
03/08/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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