INFACOL Oral suspension Ref.[6443] Active ingredients: Simethicone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Forest Laboratories UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom

Contraindications

Hypersensitivity to Simeticone or to any of the excipients listed in section 6.1.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Incompatibilities

None stated.

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