Class 4 Medicines Defect Information: Kent Pharma UK, Parasolve (Paracetamol) 500mg effervescent tablets, EL(24)A/51
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 description: Parasolve (Paracetamol) 500mg effervescent tablets, PL 51463/0032 SNOMED Code 40848611000001107
Details of the affected batches:
This Class 4 Caution In Use notification applies to all batches and all pack sizes for 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.
Kent Pharma UK has confirmed that all future batches (not listed in this notification) will contain the updated PIL.
This notification is in addition to EL 24(A)/49 and provides further information in relation to the impacted product mentioned in this notification.
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 corrected 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, Parasolve (Paracetamol) 500mg effervescent tablets, EL(24)A/51