MHRA Class 4 Medicines Defect Information: Slenyto 1mg and 5mg prolonged-release tablets

Class 4 Medicines Defect Information: Slenyto 1mg and 5mg prolonged-release tablets (PLGB 52348/0003)

Medicines Notification number: EL (21)A/29

MDR Number: MDR 247-10/21

Date issued: 15 November 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Information:

Slenyto 1mg and 5mg prolonged-release tablets

Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the below batches of products.

Slenyto 1 mg prolonged-release tablets PLGB 52348/0003, EU/1/18/1318/001

Batch Number Expiry Date Pack Size First Distributed
1049309A 31/12/2021 60 01/04/2019
1049310 31/12/2021 60 05/03/2020
1049311 31/12/2021 60 01/10/2020
1049312 31/12/2021 60 04/03/2021
1051815 31/01/2022 60 06/07/2021
80419B 31/12/2021 60 12/03/2021
90287 30/09/2022 60 22/07/2021
10175A 31/05/2024 60 Not distributed yet
10186 31/05/2024 60 Not distributed yet

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

Batch Number Expiry Date Pack Size First Distributed
00130 30/04/2023 30 15/07/2020
00409C 30/11/2023 30 Not distributed yet
10058 29/02/2024 30 Not distributed yet

Active Pharmaceutical Ingredient: Melatonin

Missing information from the PIL

Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the above batches of products. These were an older version of the PIL which did not include the most up to date safety information. The information missing from the PILs is as below:

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.”

Advice for healthcare professionals

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL. Where available, Flynn Pharma Ltd will be providing the updated PIL with all future deliveries for the affected batches.

The updated PIL is available via the electronic medicines compendium (EMC) website.

Further Information

Full Medicines Notification can be viewed here

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.