Prescribing Information

Prescribing Information

Please refer to the Summary of Product Characteristics (SmPC) for full details of Prescribing Information.

Infacol (Simeticone) 40mg/ml Oral Suspension Abbreviated Prescribing Information.

Presentation: Orange flavoured oral suspension. A white/off white opaque suspension free from particulates. Each ml contains 40mg simeticone. Indications: An antiflatulent for the relief of griping pain, colic or wind due to swallowed air. Dosage and administration: 20mg (0.5ml), one dropper full is administered before each feed. If after 3 or 4 days, symptoms do not improve, the dose may be increased to 40mg (1ml) two droppers full. Treatment with Infacol may provide a progressive improvement in symptoms over several days. Contraindications: Hypersensitivity to Simeticone or to any of the excipients. Precautions and warnings: The parahydrobenzoates used in Infacol may cause delayed hypersensitivity reactions. If symptoms persist, seek medical advice. Interactions: 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. Adverse reactions: None stated. Overdose: In the event of deliberate or accidental overdose, treat symptoms on appearance. Price: £2.71. Legal category: GSL. Marketing Authorisation Number: PL 0108/0100. Marketing Authorisation Holder: Forest Laboratories UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom. Job Code: UK/MED/18/0261. Date of Preparation: August 2018.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Teva UK Limited on 0207 540 7117 or medinfo@tevauk.com