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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 400mg Powder and Solvent for solution for injection/infusion

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
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 updated to include information on decreased bone mineral density, osteopenia, osteoprosis and fractures in patients on long-term therapy
Updated on 02/12/2011 and displayed until 13/03/2012
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 has been updated in line with the CCSI by introducing a section on lithium, updating the information on lamotrigine and how it interacts with valproate and also updating the information on carbapenem antibiotics in line with the agreed wording by the PhVWP in January 2010.
Updated on 30/11/2011 and displayed until 02/12/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   02-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 1, 2, 3, 5.1, 6.1, 6.3, 6.4 and 6.5 have been updated with the inclusion of details from the Water for Injections (Solvent) SPC and in-line with the QRD template.  This is due to the Water for Injections (Solvent) licence being merged with the Epilim IV licence.

Section 9: updated in-line with the QRD template
Updated on 28/07/2011 and displayed until 30/11/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   14-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Under liver dysfunction section age of child clarified as 3 "years".
Under women of child bearing potential - text reworded.
Recommendation against concomitant use with carbapenem agents and alcohol added.

Section 4.6 - title reworded, text about monotherapy and polytherapy moved further down
Under "in view of above data" section first paragraph has been reworded and recommendations for management of pregnant or patient planning to become pregnant included.
Hypoglycaemia risk added

Section 4.8 - reversibility of extrapyramidal symptoms clarified. Confusion, SIADH and male infertility added
Updated on 07/01/2011 and displayed until 28/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 4.8 - removal of statement regarding bone mineral density
Updated on 02/11/2010 and displayed until 07/01/2011
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:   01-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - inclusion of special warnings for women of child bearing potential
Section 4.6 - updated in line with CDS
Updated on 15/01/2010 and displayed until 02/11/2010
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 4.8 - 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


Section 4.4.1 added section regarding suicidal ideation and behaviour.

 

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 15/01/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   16-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of shelf life from 36 months to 60 months.
Updated on 23/01/2009 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 6. 4 - Special Precautions for Storage
  • 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.

 

Ammended in section 6.4 Special precautions for storage: -


Change from: -

Epilim freeze-dried powder should be stored below 25°C. Reconstituted infusion solutions: at 2-8°C if stored before use, discarding any remaining solution after 24 hours.

Change to: -

Epilim freeze-dried powder: No specific storage conditions. 

Reconstituted infusion solutions: at 2-8°C if stored before use, discarding any remaining solution after 24 hours.

Updated on 03/08/2007 and displayed until 23/01/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to manufacturer contact details
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of Market Authorisation Holder to sanofi-aventis from Sanofi-Synthelabo
Updated on 19/09/2006 and displayed until 03/08/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   10/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 02/03/2006 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Updated on 16/06/2004 and displayed until 02/03/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 23/05/2003 and displayed until 16/06/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 16/07/2002 and displayed until 23/05/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 23/08/2001 and displayed until 16/07/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 20/08/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects

Active Ingredients/Generics

 
  sodium valproate