Updated information on the use of ibuprofen in children and adolescents

The PSI would like to highlight updated information on the use of ibuprofen in children and adolescents. These changes were brought to our attention by the Health Products Regulatory Authority (HPRA) following a public assessment report for ibuprofen at European level. That full report is available to view here.

Pharmacists and pharmacy staff should be aware of the following guidance and counsel parents and carers accordingly. 

When oral or rectal ibuprofen is supplied for symptomatic treatment of mild to moderate pain and/or fever, parents and carers should be advised that:

• Medical advice should be sought for children aged 3 - 5 months if symptoms worsen, or not later than 24 hours if symptoms persist.
• Medical advice should be sought for children aged from 6 months upwards and in adolescents if symptoms worsen, or if this medicinal product is required for more than 3 consecutive days.

The Summary of Product Characteristics (SmPC) and Package Leaflet of all affected medicines are being updated to reflect this information.

(This information was included in the PSI Newsletter Issue 9 (December) 2014)