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.
