MHRA Class 4 Medicines Defect Information: Parasolve (Paracetamol) 500mg effervescent tablets (Kent Pharma UK)

MHRA Class 4 Medicines Defect Information: Parasolve (Paracetamol) 500mg effervescent tablets (Kent Pharma UK)

Drug alert number: EL (24)A/51

Date issued: 28 October 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Parasolve (Paracetamol) 500mg effervescent tablets (Kent Pharma UK)

Company name: Kent Pharma UK

Product name: Parasolve (Paracetamol) 500mg effervescent tablets, PL 51463/0032

SNOMED Code: 40848611000001107

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 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. 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 for 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.

View full alert here.

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

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