The Patient Information Leaflet (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 World Health Organisation (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.
Check which batches are impacted.
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.