Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed the MHRA that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.
Please note this is an update to to include updated batches that are affected for Crescent Pharma Ltd.
Advice for healthcare professionals
When dispensing or providing this product over the counter, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of the correct dosage instructions and maximum daily dose as stated on the carton labelling.
Correct statement: The maximum daily dose should not be more than 3 tablets (1200 mg).
Where possible, these packs should be considered to be dispensed against a prescription rather than sold over the counter to safeguard patients from taking a prescription-only dose.
The document below is the fully updated drug alert containing all impacted batches, including those identified when the drug alert was first issued.
The following document contains only the batches published as part of the updated alert.
This circular is being shared under the Open Government Copywrite licence. Whilst we will publish alerts relevant to pharmacists, pharmacy technicians and pharmacy teams we recommend you also keep an eye on the SHOW website.