Infacol - Summary of Product Characteristics (SPC)

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Forest Laboratories UK Limited
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL, UK Telephone: +44 (0)1322 421 800 Fax: +44 (0)1322 291 306 Medical Information e-mail: medinfo@forest-labs.co.uk

Summary of Product Characteristics last updated on medicines.ie: 06/05/2010

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 excipient(s)
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

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1. NAME OF THE MEDICINAL PRODUCT

Infacol 40mg/ml Oral Suspension

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.5ml dose of suspension contains 20mg of Simeticone.

For excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Oral suspension

Orange-flavoured, colourless, translucent 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).

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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

None stated

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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 overdosage, 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. It is not absorbed from the gut.

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

None stated

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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 excipient(s)

Saccharin sodium

Hypromellose

Orange flavour

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Purified water

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6.2 Incompatibilities

None stated

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6.3 Shelf life

As packaged for sale: 3 years

After first opening: 28 days

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6.4 Special precautions for storage

Do not store above 25°C.

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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.

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6.6 Special precautions for disposal and other handling

No special requirements.

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7. MARKETING AUTHORISATION HOLDER

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent

DA2 6SL.

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8. MARKETING AUTHORISATION NUMBER(S)

PA 100/41/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27^th February 1991 / 27^th February 2006

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10. DATE OF REVISION OF THE TEXT

March 2010

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Active Ingredients

Simethicone

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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