MHRA issues alert over Flamingo amitriptyline PIL errors
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a defect notification for multiple batches of Flamingo Pharma UK's amitriptyline hydrochloride 10mg, 25mg and 50mg tablets.
The alert comes as a result of an MHRA good pharmacovigilance practice inspection, and further investigation by the manufacturer, that revealed patient information leaflets (PILs) supplied with the packs do not include required safety warnings.
The missing content relates to the risk of serotonin syndrome when taken with buprenorphine, and the listing of dry eyes as a possible side effect.
The MHRA said the defect does not affect product quality and patients can continue using the medicine.
The issue affects all Flamingo Pharma UK batches of these products with expiry dates before May 2026 (multiple batches were distributed between March 2023 and August 2023, with expiry dates between December 2025 and April 2026).
Later batches, with expiry dates from May 2026 onwards, contain the corrected leaflet. Flamingo will supply updated PILs on request if pharmacies wish to supplement affected stock.
Pharmacy teams are advised to be aware of the missing information when dispensing the products. Patients should be informed that their leaflet may be missing safety information but that their medicine is safe to use.
Amitriptyline Hydrochloride tablets are used to treat depression and migraines.
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