Epilim Intravenous (sodium valproate) - Revised SPC

Source: eMC (electronic Medicines Compendium)

Date published: 25/01/2010 17:14

Type of SPC Change: Revised SPC

Generic drug name: Sodium valproate

Drug brand name: Epilim

Legal status: POM

Pharmaceutical manufacturer: Sanofi Aventis

Summary
by: Clare Greenwood

Revised SPC includes changes to:

  • Section 4.4 - Special warnings and precautions for Use - added section regarding suicidal ideation and behaviour.
  • Section 4.5 - Interaction with other medicinal products and other forms of interaction - addition of warning regarding coadministration with rifampicin and valproate blood levels.  Addition of information about coadministration with topiramate and encephalopathy and/or hyperammonaemia, including monitoring recommendations.
  • Section 4.8 - Undesirable Effects - adverse reactions added: agranulocytosis, angioedema, aplasia, DRESS and interaction with topiramate.
SPC

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