Updated on 13/03/2012 and displayed until Current
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Reasons for adding or updating:
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-
Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| 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
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| Section 4.8 has been updated to include information on decreased bone mineral density, osteopenia, osteoprosis and fractures in patients on long-term therapy
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Updated on 28/07/2011 and displayed until 13/03/2012
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| 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
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To update the SPC to include further information regarding women of child-bearing potential, carbapenem agents and alcohol in line with the CCSI. Additional typographical changes are made.
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Updated on 14/03/2011 and displayed until 28/07/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 18-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 - Specification of interchangability with "Epilim" products
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Updated on 07/01/2011 and displayed until 14/03/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 18-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 4.8 - removal of statement regarding bone mineral density
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Updated on 04/11/2010 and displayed until 07/01/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 18-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - inclusion of special warnings for women of child bearing potential
Section 4.6 - updated section to bring in line with CSI
Section 8 -
From:
Epilim Chrono 200 Controlled Release - PL 11723/0078
Epilim Chrono 300 Controlled Release - PL 11723/0021
Epilim Chrono 500 Controlled Release - PL 11723/0079
To:
Epilim Chrono 200 Controlled Release - PL 04425/0307
Epilim Chrono 300 Controlled Release - PL 04425/0308
Epilim Chrono 500 Controlled Release - PL 04425/0309
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Updated on 22/12/2009 and displayed until 04/11/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| 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
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| 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.
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Updated on 23/01/2009 and displayed until 22/12/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| 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
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| 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.
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Updated on 03/08/2007 and displayed until 23/01/2009
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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Change to manufacturer contact details
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| 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
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| Change of Marketing Authorisation Holder to sanofi-aventis from Sanofi-Synthelabo
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Updated on 19/09/2006 and displayed until 03/08/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| 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
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| Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
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Updated on 02/03/2006 and displayed until 19/09/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Updated on 16/06/2004 and displayed until 02/03/2006
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Updated on 23/05/2003 and displayed until 16/06/2004
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Updated on 26/09/2002 and displayed until 23/05/2003
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/08/2001 and displayed until 26/09/2002
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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