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Hospira UK Ltd
Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
Telephone: +44 (0)1926 820 820
Fax: +44 (0) 1926 834446
WWW: http://www.hospira.com
Medical Information Direct Line: +44 (0) 1926 834400
Medical Information e-mail: medinfouk@hospira.com
Customer Care direct line: +44 (0)1926 821 022

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: 23/08/2010
SPC Phenytoin Injection BP

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 23/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   22-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • Update to section 4.4

 (increased risk of developing Stevens Johnson Syndrome (SJS) associated with HLA-B*1502 in individuals of Thai and Han Chinese origin with phenytoin treatment) has been incorporated as a safety warning

10      DATE OF REVISION OF THE TEXT

 DATE CHANGE

22/03/2010
Updated on 23/08/2010 and displayed until 23/08/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.4     Special Warnings and Precautions for Use

           PARAGRAPHS 1 & 2 ADDED

           WARNINGS

 

           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 phenytoin.

 

           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.

 

10.      Date of (Partial) Revision of the Text

 DATE CHANGED

           29th October 2008

 
Updated on 06/01/2004 and displayed until 23/08/2010
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 21/11/2003 and displayed until 06/01/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 12/06/2002 and displayed until 21/11/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 02/08/2001 and displayed until 12/06/2002
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 02/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  phenytoin sodium