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Originator: MHRA Drug Alerts

From: G P Matthews - Medicines and Healthcare Products Regulatory Agency

Issue date: 03-Aug-2020 12:59:24

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, CRESCENT PHARMA LTD, SYRENIRING 0.120MG/0.015MG PER 24 HOURS, VAGINAL DELIVERY SYSTEM, PL 20416/0567

Broadcast content:
Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the listed 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. 

Full details of the drug alert are included in the attached PDF file. Please forward to the listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.


Additional information: NHS England and NHS Improvement Regional Offices: Please cascade this alert to Community Pharmacy.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/36

Attachments:
Cascade to:
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency