Infacol: Indications, Dosage, Precautions, Adverse Effects
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Infacol - Product Information

Manufacture: Forest Laboratories, Inc.
Country: Great Britain
Condition: Functional Gastric Disorder, Gas
Class: Miscellaneous GI agents
Form: Syrup
Ingredients: simeticone, saccharin sodium, hypromellose, orange flavour, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and purified water

Name of the Medicinal Product

INFACOL

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.

Pharmaceutical Form

Oral suspension

Clinical Particulars

Therapeutic indications

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

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.

Contraindications

None stated

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

Not applicable

Effects on Ability to Drive and Use Machines

Not applicable

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.

Overdose

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

Pharmacological Properties

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.

Pharmacokinetic Properties

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.

Pharmaceutical Particulars

List of Excipients

Saccharin Sodium

Hypromellose

Orange flavour

Methyl Hydroxybenzoate (E218)

Propyl Hydroxybenzoate (E216)

Purified Water

Incompatibilities

None stated.

Shelf Life

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

Not stated.

Marketing Authorisation Holder

Forest Laboratories UK Limited,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

Marketing Authorisation Number(s)

PL 0108/0100

Date of First Authorisation/Renewal of the Authorisation

29th October 1986 / 26th November 2001

Date of Revision of the Text

13/07/2015

11. Legal category

GSL

Company contact details

Forest Laboratories UK Limited (a subsidiary of Actavis PLC)

http://www.actavis.co.uk

Address

Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346106

Medical Information e-mail

medinfo@actavis.co.uk

Telephone

+44 (0)1271 311 200

Medical Information Direct Line

+44(0)1271 385 257