Medicines Healthcare Products Regulatory Agency
DMRC reference number
DMRC-32772688
Company name
Kent Pharma UK
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
Active Pharmaceutical Ingredient: Paracetamol
Brief description of the 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.
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.
Advice for healthcare professionals and retailers
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 for 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.
Further Information
For medical information enquiries please contact medical@kent-athlone.com
For stock control enquiries please contact customer.service@kent-athlone.com
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574