Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Kent Pharma UK, Parasolve (Paracetamol) 500mg effervescent tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Parasolve (Paracetamol) 500mg effervescent tablets (pack size: 24 Tablet). For details of the affected batch numbers, please refer to the website in MHRA.
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 notification is in addition to the notification published on 21 Oct 2024 and provides further information in relation to the impacted product mentioned in this notification.
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-parasolve-paracetamol-500mg-effervescent-tablets-el-24-a-slash-51
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by MHRA, and was posted on the Drug Office website on 22 Oct 2024.
Ends/Tuesday, Oct 29, 2024
Issued at HKT 17:00
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