Circadin 2mg prolonged-release tablets – error in patient information leaflet
(RAD Neurim Pharmaceuticals EEC Limited) Error in batches distributed since 11 February 2013. (EL (13)A/10)
20 March 2013
Class 4 medicines defect information
Caution in use
Distribute to pharmacy level
MDR 35-03/13
Product details
RAD Neurim Pharmaceuticals EEC Limited
Circadin 2mg prolonged-release tablets
(Melatonin)
EU/1/07/392/003
Alert details
Flynn Pharma Limited, distributors of Circadin 2mg prolonged-release tablets, has informed us that there is an error in the patient information leaflet (PIL) supplied in batches of this product distributed since 11 February 2013.
The error concerns the dosage instructions given under heading three, ‘How to take Circadin’, which state ‘The recommended dose is one Circadin tablet (2mg) taken daily by mouth after food, 12 hours before bedtime.’ The instructions should state ‘The recommended dose is one Circadin tablet (2mg) taken daily by mouth after food, 1-2 hours before bedtime.’ The SPC is correct and an updated version of the PIL is presented on the Electronic Medicines Compendium. Healthcare professionals are asked to ensure that patients are made aware of the correct dosage instructions.
In order to avoid stock disruption, affected stock is not being recalled. We understand that distribution of affected stock will cease as soon as stock containing the corrected PIL is available.
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practitioners and community pharmacists for information.
MHRA distribution
Further recipients by cascade:
Regional contacts for NHS trusts and provider units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)