GSL: General Sales Licence
This information is intended for use by health professionals
Excipients with known effect:
Methyl Hydroxybenzoate (E218) 0.18% w/v
Propyl Hydroxybenzoate (E216) 0.02% w/v
For the full list of excipients, see section 6.1.
A white/off white opaque suspension free from particulates.
An antiflatulent for the relief of griping pain, colic or wind due to swallowed air.
For adults and elderly:
20mg (0.5ml), one dropper full is administered before each feed. If after 3 or 4 days, symptoms do not improve, the dose may be increased to 40mg (1ml) two droppers full.
Treatment with Infacol may provide a progressive improvement in symptoms over several days.
Method of administration
Oral. Shake before use.
Hypersensitivity to Simeticone or to any of the excipients listed in section 6.1.
The parahydrobenzoates used in infacol may cause delayed hypersensitivity reactions.
If symptoms persist, seek medical advice.
Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Infacol is given concurrently to infants treated for thyroid disorders.
Reporting of suspected adverse reactionsReporting 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the event of deliberate or accidental overdosage, treat symptoms on appearance.
Simeticone is an anti-flatulent with ATC code A03AX13.
Physiologically the active ingredient is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract.
The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus.
Simeticone is not absorbed from the gastrointestinal tract.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Methyl Hydroxybenzoate (E218)
Propyl Hydroxybenzoate (E216)
As packaged for sale : 3 years
After first opening : 28 days.
Do not store above 25°C).
High-density polyethylene bottle fitted with a low-density polyethylene dropper and evoprene teat containing 50ml, 55ml, 75ml, 85ml and 100ml of liquid.
Forest Laboratories UK Limited,
29th October 1986 / 20 January 1997
Field House, Station Approach, Harlow, Essex, CM20 2FB
+44 (0)207 540 7169
+44 (0)207 540 7000
+44 (0)207 540 7117
+44 (0)207 540 7349