Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.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: 16/08/2011
SPC Lamictal

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 16/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   20-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections revised:

4.4 Updated with additional information on Aseptic Meningitis

4.8 Reorganised utilising the MedDRA table format.  Single tables for Epilepsy and Bipolar Disorder have been created.

10 Updated with new date of revision of text
Updated on 26/05/2011 and displayed until 16/08/2011
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-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Updated with information on the interaction with Aripiprazole
Section 10 - Updated with new date of revision of text
Updated on 10/05/2011 and displayed until 26/05/2011
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:   20-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections amended:

4.5 Updated with information regarding interaction with OCT2 substrates

10 Updated with new date of revision of text
Updated on 23/12/2010 and displayed until 10/05/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
  • Addition of Black Triangle
Date of revision of text on the SPC:   21-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to SPC:

Section 1-addition of black triangle to marketed strengths and removal of unmarketed strengths
Section 2- removal of unmarketed strengths
Section 3- removal of unmarketed strengths
Section 10- change of revision date to 21/12/10
Addition of black trinagle to all marketed strengths
Updated on 02/11/2010 and displayed until 23/12/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section        Summary of change

4.2     Clairification of dosage in table 4
         Addition of information reagrding use with atazanavir/ritonavir

4.5     Addition of information regarding use  with atazanavir/ritonavir

4.8     An update to pregnancy information based on post marketing data
          An update on breast feeding

4.9      Updated-out of date information removed

10       New date
Updated on 09/07/2010 and displayed until 02/11/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.6 - Update to information on pregnancy and congenital malformations from post marketing data

Section 4.8 -

• Addition of lymphadenopathy and an adverse reaction

• Addition of aseptic meningitis as an adverse reaction
Updated on 02/11/2009 and displayed until 09/07/2010
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   19-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC Harmonised - the entire SPC has been affected
Updated on 17/09/2007 and displayed until 02/11/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 Nature and Contents of Container
- to reflect the UK marketed pack sizes for Lamictal Tablets 50 mg (42 or 56s) and Lamictal Dispersible 100 mg (56s, not 28s).
 
Section 10: 1st march 2007
Updated on 05/03/2007 and displayed until 17/09/2007
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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 20/02/2007 and displayed until 05/03/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/11/2006 and displayed until 20/02/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 13/09/2006 and displayed until 24/11/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 11/09/2006 and displayed until 13/09/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 11/07/2005 and displayed until 11/09/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 29/06/2005 and displayed until 11/07/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 09/02/2004 and displayed until 29/06/2005
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
Updated on 13/08/2003 and displayed until 09/02/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/04/2003 and displayed until 13/08/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 29/05/2002 and displayed until 22/04/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 05/02/2002 and displayed until 29/05/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 10/07/2001 and displayed until 05/02/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 19/01/2001 and displayed until 10/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  lamotrigine