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Deals & regulation

MHRA warns of incorrect co-amoxiclav dosing instructions in all Sandoz batches

gov.uk

The MHRA says Sandoz’s dosing table for co-amoxiclav 250/62.5 mg/5mL suspension incorrectly instructed weight-adjusted doses that could provide about twice the intended amount. The product itself is not defective, but the faulty prescribing information has been removed while a corrected version is processed. Patients should continue taking the medicine as prescribed and seek medical advice if they may have taken a higher dose and develop symptoms. Reported risks include gastrointestinal effects, dehydration and, rarely, kidney injury.

Editorial summary · Publisher article

What matters

  • The dosing table in the product information should not be used for weight-adjusted administration.
  • All batches are currently affected, while the powder’s quality is not impacted.
  • Potential overdose effects include diarrhoea, nausea, vomiting, abdominal pain and dehydration.

Context & caveats

  • The notice concerns incorrect instructions, not contaminated or poor-quality medicine.
Why this made the edition

A specific medicines safety notification identifies a dosing-table error affecting all batches and explains the potential overdose risk and corrective advice.

Source material