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Slenyto PIL problems

Missing safety information; batches not being recalled

November 17th 2021

Tagged: MHRA alert

By MHRA

RAD Neurim Pharmaceuticals EEC SARL, distributed by Flynn Pharma, has issued an alert relating to an obsolete patient information leaflet (PIL) for various batches of Slenyto 1 and 5mg prolonged-release tablets (melatonin).

The affected batches are:

Batch numberExpiry datePack sizeFirst distributed
1049309A31/12/202160 tablets01/04/2019
104931031/12/202160 tablets05/03/2020
104931131/12/202160 tablets01/10/2020
104931231/12/202160 tablets04/03/2021
105181531/01/202260 tablets06/07/2021
80419B31/12/202160 tablets12/03/2021
9028730/09/202260 tablets22/07/2021
10175A31/05/202460 tabletsNot distributed yet
1018631/05/202460 tabletsNot distributed yet

Slenyto 5 mg prolonged-release tablets PLGB 52348/0004, EU/1/18/1318/003

Batch numberExpiry datePack sizeFirst distributed
0013030/04/202330 tablets15/07/2020
00409C30/11/202330 tabletsNot distributed yet
1005829/02/202430 tabletsNot distributed yet

Obsolete PILS are missing the following safety information:

Section 2 Other medicines and Slenyto: This should include “- beta-blockers (used to control blood pressure). These medicines should be taken in the morning.”

Section 6 Contents of the pack and other information: In the section “What Slenyto looks like and contents of the pack”, the number “30 / ” is missing from the approved wording for the 1 mg tablet pack size and should state “Available in blister packs of 30 / 60 tablets.”

Healthcare professionals asked to provide an updated PIL where possible, available via the electronic medicines compendium (EMC). These batches are not being recalled.

For more information, medical information queries or replacement PIL enquiries, please contact: Flynn Pharma Ltd Medical Information Department on 01438 727822, email – medinfo@flynnpharma.com.

For stock control queries, please contact: Flynn Pharma Ltd on 01438 727822.