Prescribing information for Sandoz co-amoxiclav 250/62.5 mg/5 ml powder for oral suspension contains a dosing table that gave about twice the intended dose, the MHRA said on Thursday.
Sandoz Limited told the regulator of errors in the dosing table in the summary of product characteristics (SmPC) for the medicine, which contains amoxicillin trihydrate and potassium clavulanate and is licensed under PL 04416/0515.
The alert is a class 4 defect notification, reference EL(26)A/46.
The table in Section 4.2, which sets out weight-adjusted dosing, is incorrect and should not be used. The MHRA said it instructed an amount of suspension that provided "approximately twice the intended, recommended dose".
All batches are currently affected. The regulator said the quality of the powder for oral suspension is not affected, so the fault lies in the dosing instructions rather than in the medicine itself.
The faulty SmPC has been removed from the MHRA products website and the electronic medicines compendium. Both will carry the document again once Sandoz has been granted a variation to its market authorisation for the corrected version.
Until then, healthcare professionals are told not to use the Sandoz SmPC to calculate weight-adjusted doses. The corrected dosing information supplied by Sandoz is set out in an annex to the alert.
The MHRA said that following the faulty table creates a potential for overdose, which may raise the likelihood of known dose-related adverse effects.
These include antibiotic-associated diarrhoea, nausea, vomiting and abdominal pain, along with dehydration and disturbed fluid and electrolyte balance, and a higher risk of hypersensitivity and other adverse reactions.
Amoxicillin crystalluria, including acute renal injury or renal failure, has been reported. The regulator described it as very rare and predominantly associated with parenteral therapy.
Patients should continue to take the medicine as prescribed, the MHRA said. Anyone who believes they have taken or given the higher dose and has side effects such as diarrhoea, nausea, vomiting or abdominal pain should seek immediate medical advice.
Patients who are unsure or have questions are directed to their pharmacy or other healthcare professionals involved in their treatment. Suspected adverse reactions should also be reported through the MHRA Yellow Card scheme.
Sandoz handles medical information enquiries on this product by email and on 01276 698101.
The MHRA's Defective Medicines Report Centre asked recipients to pass the alert to relevant contacts. NHS regional teams are asked to forward it to community pharmacists and dispensing GPs.
It is not the first class 4 alert to cover this product. In April 2023, the MHRA issued alert EL (23)A/14 on Sandoz co-amoxiclav products, including the same 250/62.5 mg/5 ml strength, because cartons said "sugar free" in error.
That wording had been added to the carton in December 2008. The MHRA said then that there was no risk to product quality and the affected batches were not being recalled.