Infacol - Product Information
|Manufacture:||Forest Laboratories, Inc.|
|Condition:||Functional Gastric Disorder, Gas|
|Class:||Miscellaneous GI agents|
|Ingredients:||simeticone, saccharin sodium, hypromellose, orange flavour, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and purified water|
Name of the Medicinal Product
Qualitative and Quantitative Composition
Methyl Hydroxybenzoate (E218) 0.18% w/v
Propyl Hydroxybenzoate (E216) 0.02% w/v
For the full list of excipients, see section 6.1.
An antiflatulent for the relief of griping pain, colic or wind due to swallowed air.
Posology and method of administration
For Adults and Elderly
20mg (0.5ml) administered before each feed. If necessary this may be increased to 40mg (1ml). Treatment with Infacol may provide a progressive improvement in symptoms over several days.
Special Warnings and Precautions for Use
The parahydrobenzoates used in Infacol may cause delayed hypersensitivity reactions.
If symptoms persist, seek medical advice.
Interaction with Other Medicinal Products and Other Forms of Interaction
Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Infacol is given concurrently to infants treated for thyroid disorders.
Pregnancy and Lactation
Effects on Ability to Drive and Use Machines
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
In the event of deliberate or accidental overdose, treat symptoms on appearance.
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.
Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of Excipients
Methyl Hydroxybenzoate (E218)
Propyl Hydroxybenzoate (E216)
As packaged for sale : 3 years
After first opening : 28 days.
Special Precautions for Storage
Do not store above 25°C.
Nature and Contents of Container
High-density polyethylene bottle fitted with a low-density polyethylene dropper and evoprene teat containing 50ml of liquid.
Special Precautions for Disposal and Other Handling
Marketing Authorisation Holder
Forest Laboratories UK Limited,
Marketing Authorisation Number(s)
Date of First Authorisation/Renewal of the Authorisation
29th October 1986 / 26th November 2001
Date of Revision of the Text
11. Legal category
Company contact details
Forest Laboratories UK Limited (a subsidiary of Actavis PLC)
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346106
Medical Information e-mail
+44 (0)1271 311 200
Medical Information Direct Line
+44(0)1271 385 257