Class 4 Medicines Defect Information: Kent Pharma UK, Paracetamol 500mg Effervescent Tablets, EL(24)A/49

Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.

DMRC/MDR Number: DMRC-32772688

Company name: Kent Pharma UK

Product descriptions: 

• Paracetamol 500mg Effervescent x100 Tablets (P), PL 51463/0031 SNOMED Codes 1856211000001101 (5x20) 1856011000001106 (10x10)
• Paracetamol 500mg Effervescent x60 Tablets (P), PL 51463/0031 SNOMED Code 1855911000001103
• Paracetamol 500mg Effervescent x24 Tablets (GSL), PL 51463/0032 SNOMED Code 2274411000001102
• Paracetamol 500mg Effervescent x16 Tablets (GSL), PL 51463/0032 SNOMED Code 2274211000001101

Details of affected batches:

This Class 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 of the recall document.

Brief description of problem:

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.

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.

Advice to Healthcare Professionals:

Whilst the correct sodium content per single dosage is provided on the product carton and in the Summary of Product Characteristics (SmPC), healthcare professionals should be aware that the PIL contains incorrect information regarding the sodium content of the maximum daily dosage of product.

When selling or dispensing all batches of this medicine, where possible, advise patients of the correct sodium levels as per the carton. As noted in the PIL, patients should be advised to speak to their pharmacist or doctor if they need effervescent paracetamol on a daily basis for a prolonged period of time, especially if they have been advised to follow a low salt diet.

Advice to Patients:

The leaflet included with Paracetamol 500mg Effervescent Tablets contains incorrect information about the sodium content in the maximum daily dose for this medicine. The correct sodium content per single dose is provided on the product carton. Each tablet contains 438mg of sodium and maximum amount of sodium that would be consumed will be 3504mg sodium, based on taking the maximum of eight (8) paracetamol tablets in 24 hours.

Patients, especially those on low-sodium diets, are advised to consult their healthcare professional if they need effervescent paracetamol over a prolonged period of time.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information enquiries please contact medical@kent-athlone.com

For stock control enquiries please contact customer.service@kent-athlone.com

To access the full recall: Class 4 Medicines Defect Information: Kent Pharma UK, Paracetamol 500mg Effervescent Tablets, EL(24)A/49