Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets. The PIL incorrectly states that the maximum daily dose contains 438mg of sodium, whereas this is the sodium content for a single dose. The maximum daily dose is in fact 3504mg of sodium. The leaflet also inaccurately indicates that the maximum daily dose represents 22% of the WHO recommended daily sodium intake, whereas it should state 175% of the WHO recommended daily sodium intake. These errors may pose a risk to patients who need to control their sodium intake. 

This Cass 4 Caution In Use notification applies to all batches and all pack sizes for both PL 51463/0031 and PL 51463/0032, and the expiry dates for these batches range from August 2025 to December 2027. Kent Pharma UK has shared further details of all batches impacted in Appendix 1. Due to supply considerations and no current availability of the correct PIL, batches listed as not yet distributed will not be repackaged with the updated PIL prior to distribution. The specified ‘Not yet distributed’ batches are scheduled to be distributed shortly to avoid any supply considerations. Kent Pharma UK has confirmed that all future batches (not listed in this notification) of the product released to market after 01 February 2025 will contain the updated PIL.