Summary of Product Characteristics
last updated on the eMC:
02/11/2010
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 02/11/2010 and displayed until Current
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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: 11-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 in line with CDS
Section 8 - change in ownership from PL11723/0020 to PL04425/0303
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Updated on 07/05/2010 and displayed until 02/11/2010
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 26-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Previous joint SPC now split to individual SPCs for each presentation
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Updated on 22/12/2009 and displayed until 07/05/2010
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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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 Market 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 in 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 4.4 - Special Warnings and Precautions for Use
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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 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/08/2001 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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