The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class four medicines defect alert for SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system of Crescent Pharma Ltd.
Crescent Pharma Ltd has informed the MHRA that the patient information leaflet (PIL) within the packs for the batches listed below 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.”
Product details
| Batch Number | Expiry Date | Pack Size | First Distributed |
| LF18276AA | 08/2021 | 3×1 | March 2020 |
| LF18894AA | 11/2021 | 3×1 | April 2020 |
It is important that any patients are provided with information on warnings and precautions whilst taking SyreniRing, the company has said.
Additionally, patients who notice the symptoms or side effects or mood effects should seek immediate medical advice.
The healthcare professionals have been adviced to 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 web site, the company has said.
