DENTINOX INFANT COLIC DROPS Oral suspension Ref.[49653] Active ingredients: Simethicone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Dendron Brands Limited, 94, Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ, United Kingdom

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4. Special warnings and precautions for use

Keep all medicines out of the reach of children.

If symptoms persist obtain medical advice.

4.5. Interaction with other medicinal products and other forms of interaction

Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Dentinox Infant Colic Drops are given concurrently to infants treated for thyroid disorders.

4.6. Pregnancy and lactation

Not applicable.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

None known.

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, website: www.mhra.gov.uk/yellowcard.

6.2. Incompatibilities

None known.

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