Winthrop Pharmaceuticals UK Ltd

One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

Summary of Product Characteristics last updated on the eMC: 30/11/2009
SPC Zolpidem Tartrate 10 mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 30/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   27-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

addtitional warnings added to 4.4 and 4.8 re somnambulism
additional warning added to 4.6 re neonatal respiratory depression
Updated on 03/11/2009 and displayed until 30/11/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   zolpidem tartrate