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 CodeProduct DescriptionLiveryAffected Batch

1110980ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1073626ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1076074ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

1073584ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

1110998ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

1073618ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL STOCK

8094740ZOPICLONE TAB 3.75MGRatiopharm UK Limited and Generics [UK] Limited t/a MylanALL STOCK

8094757ZOPICLONE TAB 7.5MGGenerics [UK] Limited t/a MylanALL 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.