Infacol

1. Name Of The Medicinal Product

INFACOL

2. Qualitative And Quantitative Composition

Simeticone 40mg/ml

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.

4.3 Contraindications

None stated

4.4 Special Warnings And Precautions For Use

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

4.9 Overdose

In the event of deliberate or accidental overdose, treat symptoms on appearance.

5. Pharmacological Properties

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 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.

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

Do not store above 25°C.

6.5 Nature And Contents Of Container

High-density polyethylene bottle fitted with a low-density polyethylene dropper and evoprene teat containing 50ml of liquid.

6.6 Special Precautions For Disposal And Other Handling

Not stated.

7. Marketing Authorisation Holder

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent DA2 6SL

8. Marketing Authorisation Number(S)

PL 0108/0100

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th October 1986 / 26^th November 2001

10. Date Of Revision Of The Text

26th April 2011

11. Legal Category

GSL