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- NHS Regional Offices
- NHS Foundation Trusts (England) - Medical Director
- NHS Trusts (England) - Medical Director
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- 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
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| Title: |
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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
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| Broadcast content: |
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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.
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| Additional information: |
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NHS England and NHS Improvement Regional Offices: Please cascade this alert to Community Pharmacies.
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| Cascade to: |
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- #GP#
- #COMMUNITYPHARMACISTS#
- #DISPENSING GP#
- #HospitalPharmacy#
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