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

Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Telephone: +44 (0)1276 692 255
Fax: +44 (0)1276 698 449
Medical Information Direct Line: +44 (0)1276 698 370
Medical Information e-mail: medinfo.uk@novartis.com
Customer Care direct line: +44 (0)845 741 9442

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: 08/05/2012
SPC Trileptal 150 mg, 300 mg, 600 mg Film-coated tablets

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 08/05/2012 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:   20-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to Section 4.8

Implementation of PhVWP text regarding the risk of bone disorders for all products containing carbamazepine and oxcarbazepine.
Updated on 13/10/2010 and displayed until 08/05/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 updated to include the names Oxcarbazepine 150mg Film-coated Tablets, Oxcarbazepine 300mg Film-coated Tablets and Oxcarbazepine 600mg Film-coated Tablets.

Section 9 includes the renewal date of 15 October 2009.

Section 10 refers to the approval of Section 1 as that is the later date.
Updated on 01/09/2009 and displayed until 13/10/2010
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:   27-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to section 4.6 - rewording of a sentence:Determination of changes in MHD plasma concentrations should be considered.

Update to section 4.8 - addition of:

Unknown:  decrease in T4 (with unclear clinical significance)

 
Updated on 01/07/2009 and displayed until 01/09/2009
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • 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:   27-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to sections 4.4, 4.6, 4.8 and 5.2 of the SPC
Updated on 11/03/2009 and displayed until 01/07/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   16-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SECTION 4.4:

The following paragraph has been added:

Suicidal behaviour

Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomized placebo controlled trials of antiepileptic 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 oxcarbazepine.
Updated on 28/08/2008 and displayed until 11/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.2 - Pharmacokinetic Properties
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   21-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


·         Section 4.4 (Special warnings and special precautions for use) has been amended as a consequence of the changes made to Section 4.8 (see below)

 

·         Section 4.8 (Undesirable effects) has been amended with regard to hypersensitivity (addition of information related to multi-organ hypersensitivity) and blood dyscrasias (addition of new undesirable effects: bone marrow depression, aplastic anemia, agranulocytosis, pancytopenia and neutropenia)

 

·         Minor administrative changes have been made in sections 4.2, 4.5, 4.6, 4.7, 5.1, 5.2 and 5.3.  A typing error has also been corrected in the mg to ml conversion table of the oral suspension SmPC.

Updated on 09/03/2006 and displayed until 28/08/2008
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 5.2 - Pharmacokinetic Properties
Updated on 09/09/2005 and displayed until 09/03/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 19/08/2005 and displayed until 09/09/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 16/02/2005 and displayed until 19/08/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 07/01/2005 and displayed until 16/02/2005
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 28/09/2004 and displayed until 07/01/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/05/2002 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 24/08/2001 and displayed until 24/05/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 17/08/2001 and displayed until 24/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 23/03/2001 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 17/05/2000 and displayed until 23/03/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  oxcarbazepine