Class 4 Medicines Defect Information - Crescent Pharma Ltd, SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system, EL (20)A/36
Original Alert (August 2020) - Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches are missing important safety relevant text changes.
Update (November 2021) - The MHRA has been informed that further batches were released which did not contain the safety information, as detailed in the original class 4 notification. Please see details relating to the original batches and additional batches that are subject to this notification. The PIL link has also been updated.
MDR Number MDR 031-07/20
Company name Crescent Pharma Ltd
Product description SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system
Details of the affected batches:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
LF18276AA |
08/2021 (expired) |
3x1 |
March 2020 |
|
LF18894AA |
11/2021 |
3x1 |
April 2020 |
|
LF18894AAA |
11/2021 |
3x1 |
February 2021 |
|
LF20272AAA |
04/2022 |
3x1 |
February 2021 |
|
LF20382BAA |
05/2022 |
3x1 |
April 2021 |
|
LF21671AA |
10/2022 |
3x1 |
January 2021 |
Brief description of problem
Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the above batches is missing important safety relevant text changes. The changes to the PIL include the addition of the following information:
- Warnings and precautions Psychiatric disorders: Some women using hormonal contraceptives including SyreniRing have reported depression or depressed mood.
- Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
It is important that any patients are provided with information on warnings and precautions whilst taking SyreniRing. Additionally, patients who notice the symptoms/side effects or mood effects should seek immediate medical advice.
Advice to Healthcare Professionals
When dispensing this product, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of any missing information.
The current PILs includes the special warning and precautions and should be issued when this product is dispensed. This can be obtained from the
SyreniRing Vaginal Delivery System - PIL
Company contacts for further information
For more information or medical information queries, please contact: Crescent Pharma Ltd. Medical Information Department on:
Email: tiago.barca@pharsolution.com
Tel: +44 (0) 1256 772740.
To access the full recall: EL (20)A/36