Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers

This document is intended to provide communication to The Holder of Certificate of Registration for Codeine containing products.

The Advisory Clinical Committee (ACC) reviewed data submitted by HCRs to support the continued use of codeine in children under 12 years and concluded that there is evidence indicating that codeine-containing medicines are associated with respiratory complications when used in children under the age of 12 years. There have been several publications including PSURS and PBRERs indicating an unacceptable risk, including fatal outcomes when codeine-containing medicines have been administered to children.