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Class 4 Caution in Use on Zopiclone 3.75mg & 7.5mg Tablets

Class 4 Caution in Use on Zopiclone 3.75mg & 7.5mg Tablets

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.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP Code Product Description Livery Affected Batch
1110980 ZOPICLONE TAB 3.75MG Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan ALL STOCK
1073626 ZOPICLONE TAB 3.75MG Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan ALL STOCK
1076074 ZOPICLONE TAB 3.75MG Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan ALL STOCK
1073584 ZOPICLONE TAB 7.5MG Generics [UK] Limited t/a Mylan ALL STOCK
1110998 ZOPICLONE TAB 7.5MG Generics [UK] Limited t/a Mylan ALL STOCK
1073618 ZOPICLONE TAB 7.5MG Generics [UK] Limited t/a Mylan ALL STOCK
8094740 ZOPICLONE TAB 3.75MG Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan ALL STOCK
8094757 ZOPICLONE TAB 7.5MG Generics [UK] Limited t/a Mylan ALL STOCK

For more information or medical information queries, please contact: Ratiopharm UK Limited Teva UK Medical Information at: medinfo@tevauk.com or Tel No: 0207 540 7117

Generics [UK] Limited t/a Mylan Medical Information Direct Line +44 (0)1707 853 000 select option 1, Customer Care direct lin+44 (0)1707 853 000 select option 2 or via Medical Information e-mail info@mylan.co.uk

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

 

This may have been supplied by AHDL. Unfortunately we are not providing specific batch information you will be required to follow the instructions as per the drug alert.

 

This is a caution in use only we are not accepting stock returns.

 

If you have any questions, then please contact your local Service Centre Customer Services team.