Active substance(s): SIMETICONE
NAME OF THE MEDICINAL PRODUCT
Wind-eze Gel Caps
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains: 125mg Simeticone (activated dimeticone)
For excipients see 6.1
The capsules are oval gelatin capsules with a white to off white opaque gelatin
The symptomatic relief of flatulence, wind pains, bloating, abdominal
distension and other symptoms associated with gastrointestinal gas.
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. Maximum daily dose: Four gel capsules (500mg
Simeticone) in any 24 hours.
Do not exceed the stated dose.
Children under 12 years of age:
Simeticone is contraindicated in patients with a previous history of hypersensitivity to
simeticone or excipients.
Special warnings and precautions for use
If symptoms persist for more than 14 days, or if symptoms worsen, medical advice
must be sought.
Keep out of the reach and sight of children.
This medicinal product contains glycerol. Harmful in high doses. Can cause
headache and can cause stomach upset and diarrhoea.
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.
Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if
Wind-eze Gel Caps are taken concurrently to treatment for thyroid disorders.
Pregnancy and Lactation
Medical advice should be sought prior to taking this product if pregnant.
Effects on ability to drive and use machines
Minor adverse effects: nausea and constipation. Rarely hypersensitivity
reactions such as rash, pruritis, facial oedema, tongue oedema, respiratory
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product
is important. It allows continued monitoring of the benefit/risk balance of the
medicinal product. Healthcare professionals are asked to report any suspected
adverse reactions via the Yellowcard Scheme at: www.mhra.gov.uk/yellowcard.
In the unlikely event of deliberate or accidental overdosage, treat symptoms on
appearance. There are no special procedures recommended.
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
Simeticone is not absorbed following oral administration.
Preclinical safety data
Simeticone is physiologically inert and considered to be non-toxic. Preclinical
data reveal no hazard for humans.
List of excipients
Titanium Dioxide (E171)
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Blister packs of construction PVDC /PVC and aluminium foil with heat
Pack sizes: 10, 20, 30, 50 and 60.
Not all pack sizes may be marketed.
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
16 June 1997
DATE OF REVISION OF THE TEXT