Source: Medicines & Healthcare products Regulatory Agency (MHRA)
Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have released a notification that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect. The PIL in the above batches includes incorrect dosing instructions in Section 3, How to take Ibuprofen.
The leaflet incorrectly states that ‘The maximum daily dose should not exceed 6 [six] tablets (2400 mg).’ This dosing regimen should only be given to patients who are under the supervision of their GP or healthcare prescriber and have been prescribed Ibuprofen 400mg Tablets. The outer carton contains the correct P indications and posology.
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 batch numbers (which are included in the link below) 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 [three] 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.