Class 4

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

Crescent pharma website

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:Ā tiago.barca@pharsolution.com

Tel: +44 (0) 1256 772740.

To access the full recall: EL (20)A/36