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Forest Laboratories UK Limited

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL

Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 24/10/2011

SPC

Infacol

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. Legal Category

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1. NAME OF THE MEDICINAL PRODUCT

INFACOL

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Simeticone 40mg/ml

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3. PHARMACEUTICAL FORM

Oral suspension

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

An antiflatulent for the relief of griping pain, colic or wind due to swallowed air.

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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.

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4.3 Contraindications

None stated

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4.4 Special warnings and precautions for use

If symptoms persist, seek medical advice.

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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.

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4.6 Pregnancy and lactation

Not applicable

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4.7 Effects on ability to drive and use machines

Not applicable

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4.8 Undesirable effects

None stated

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4.9 Overdose

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

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5. PHARMACOLOGICAL PROPERTIES

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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.

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5.2 Pharmacokinetic properties

Simeticone is not absorbed from the gastrointestinal tract.

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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.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Saccharin Sodium