The dosing table had instructed users to administer an amount that was around twice the intended, recommended dose – with the error affecting all batches.
The correct strength is 250/62.5 mg/5ml.
As a result, those taking the medication have been warned that the dosing table provided within the packaging should not be used due to the potential risk of overdose.
However, patients should continue to take this medication as prescribed – the quality of the product is not impacted by the defect.
The incorrect table has been removed from the MHRA products and electronic medicines compendium (eMC) websites.
Dose-related adverse reactions include an increased risk of diarrhoea, nausea, vomiting, abdominal pain and dehydration.