Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44
Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leafletwithin all packs and the Summary of Product Characteristics for Ratiopharm is missing important safety information related to potential suicide risks.
Source:
Medicines and Healthcare products Regulatory Agency