Infacol
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
INFACOL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Simeticone 40mg/ml
Excipients:
Methyl Hydroxybenzoate (E218) 0.18% w/v Propyl Hydroxybenzoate (E216) 0.02% w/v
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
An antiflatulent for the relief of griping pain, colic or wind due to swallowed air.
4.2. Posology and Method of Administration
For adults and elderly:
Not applicable.
For infants:
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.
Contra-Indications
4.3.
None stated.
4.4 Special warnings and precautions for use
The parahydrobenzoates used in infacol may cause delayed hypersensitivity reactions.
If symptoms persist, seek medical advice.
4.5 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.
4.6. Pregnancy and Lactation
Not applicable.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8 Undesirable effects
None stated.
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.
4.9. Overdose
In the event of deliberate or accidental overdosage, treat symptoms on appearance.
PHARMACOLOGICAL PROPERTIES
5.
5.1. Pharmacodynamic Properties
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.
5.2. Pharmacokinetic Properties
Simeticone is not absorbed from the gastrointestinal tract.
5.3. Pre-clinical 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.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Saccharin Sodium Hypromellose Orange flavour
Methyl Hydroxybenzoate (E218)
Propyl Hydroxybenzoate (E216)
Purified Water
6.2. Incompatibilities
None stated.
6.3 Shelf life
As packaged for sale : 3 years After first opening : 28 days.
6.4. Special Precautions for Storage
Store at room temperature (below 25°C).
6.5. Nature and Content of Container
High-density polyethylene bottle fitted with a low-density polyethylene dropper and evoprene teat containing 50ml, 75ml and 100ml of liquid.
6.6. Instructions for Use, Handling and Disposal
Not stated.
7 MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited,
Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
8. MARKETING AUTHORISATION NUMBER(S)
PL 0108/0100
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
29th October 1986 / 20 January 1997
10 DATE OF REVISION OF THE TEXT
13/07/2015