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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 10-Sep-2020 12:59:34

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
  • GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks
  • GP Practices 1

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, ZOPICLONE 3.75MG TABLETS (PL 15773/0028), ZOPICLONE 7.5MG TABLETS (PL 15773/0029), RATIOPHARM UK LIMITED, AND ZOPICLONE 3.75MG TABLETS (PL 04569/0450), GENERICS UK T/A MYLAN

Broadcast content: Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important safety information related to potential suicide risks.

Advice for healthcare professionals
Patients should be made aware that the information on the possible risk of suicide is missing from the PIL provided in their packs. When dispensing this product, please check the Marketing Authorisation Holder; if any of the products listed in the alert are being dispensed, ensure that patients are aware of the missing information by providing guidance in relation to the risk identified and by providing a copy of this alert. 

Full details of the drug alert are included in the attached PDF file. Please forward to 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 Pharmacies.

Alert reference: EL (20)A/44

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency