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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 13/03/2012
SPC Epilim Chronosphere 100mg

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 13/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 has been updated to include information on decreased bone mineral density, osteopenia, osteoprosis and fractures in patients on long-term therapy
Updated on 28/07/2011 and displayed until 13/03/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to the SPC to include further information regarding women of childbearing potential, carbapenem agents and alcohol.
Updated on 04/10/2010 and displayed until 28/07/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   16-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of special warnings for women of child bearing potential
Section 4.6 - updating risk information associated with seizures, the risk of malformations occurring, lactation and autistic spectrum disorders.
Updated on 22/12/2009 and displayed until 04/10/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   30-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.5, susbsection 4.5.1 - risk of rash with coadministration of lamotrigine reworded.
subsection 4.5.2 - addition of warning regarding coadministration with rifampicin and valproate blood levels.
Subsection 4.5.3 - addition of information about coadministration with topiramate and encephalopathy and/or hyperammonaemia, including monitoring recommendations.

 

In section 4.8 - adverse reactions added: agranulocytosis, angioedema, aplasia, DRESS and interaction with topiramate. Confusion removed.


In section 4.9 - A favourable outcome is usual, however some deaths have occurred following massive overdose has been added to the end of the paragraph identifying signs of massive overdose.

Sentence at end of section regarding successful use of haemodialysis and haemoperfusion added.

Updated on 20/02/2009 and displayed until 22/12/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   05-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of marketing authorisation numbers following change of ownership.
Updated on 27/01/2009 and displayed until 20/02/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Addition of the following warning in Section 4.4.1 (Special Warnings): -


Suicidal ideation and behaviour:


Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for valproate semisodium.

 

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Updated on 01/07/2008 and displayed until 27/01/2009
Reasons for adding or updating:
  • New SPC for new product
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

 
  valproic acid
  sodium valproate