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Cephalon (UK) Limited
Teva UK Limited, Field House, Station Approach, Harlow, Essex, CM20 2FB
Telephone: +44 (0) 207 5407117
Fax: +44 (0) 207 4507349
WWW: http://www.tevauk.com
Medical Information Direct Line: +44 (0) 207 5407117
Medical Information e-mail: medinfo@tevauk.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: 06/07/2011
SPC Gabitril 5 mg, Gabitril 10 mg, Gabitril 15 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 06/07/2011 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
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The amendments relate to the addition of new adverse reactions to section 4.8 of the SmPC (including reformatting of this section in line with the EU SmPC guideline), and also addition of a warning to section 4.4 (regarding serious rash).

Updated on 15/02/2011 and displayed until 06/07/2011
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.9(Overdose), new terms have been added in line with the Reference Safety Information for tiagabine hydrochloride and to include use of activated charcoal for management of overdose, in line with the current information from Toxbase.
Updated on 09/12/2010 and displayed until 15/02/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   03-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 has been updated to better describe the posology for hepatic impaired patients; consequently, section 5.2 has been updated to add pharmacokinetic properties of tiagabine in hepatic impairment.
Updated on 11/01/2010 and displayed until 09/12/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   22-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following has been added to section 4.3:
"Severely impaired liver function" 
The following has been deleted from section 4.4:
"Gabitril should not be used in patients with severely impaired hepatic function"
Updated on 30/06/2009 and displayed until 11/01/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Anti-epileptic agents that induce hepatic enzymes (such as phenytoin, carbamazepine, phenobarbital and primidone) enhance the metabolism of tiagabine.  Consequently, patients taking enzyme-inducing drugs may require doses of tiagabine above the usual dose range the usual dose range.”
Updated on 10/02/2009 and displayed until 30/06/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SmPC has been updated to add: cases of encephalopathy have been reported (frequency unknown
Updated on 18/11/2008 and displayed until 10/02/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   28-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 of the SmPC has been updated to add:

Suicidal ideation and behavior 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 Gabitril

 

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.

Updated on 28/03/2008 and displayed until 18/11/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10: the date of revision of text has changed from December 2007 to March 2008
Updated on 25/03/2008 and displayed until 28/03/2008
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section1 updated to include  'film coated' tablets.
 
Section 3  pharmaceutical form updated.
Updated on 24/01/2008 and displayed until 25/03/2008
Reasons for adding or updating:
  • Change to manufacturer contact details
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 the Marketing Authorisation Holder's contact details has changed from 11/13 Frederick Sanger Road, Surrey Research Park, Guildford, Surrey GU2 7YD TO 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire, AL7 3BT, UK
Updated on 01/10/2007 and displayed until 24/01/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4

Add warning re: the risk of convulsions in non-epileptic patients*
Updated on 21/09/2004 and displayed until 01/10/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/11/2002 and displayed until 21/09/2004
Reasons for adding or updating:
  • Addition of Legal Category
Updated on 06/11/2002 and displayed until 25/11/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/11/2002 and displayed until 06/11/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 30/09/2002 and displayed until 06/11/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  tiagabine hydrochloride monohydrate