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Bristol-Myers Squibb Pharmaceutical Limited
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Telephone: +44 (0)1895 523 000
Fax: +44 (0)1895 523 010
Medical Information Direct Line: +44 (0)1895 523 740
Medical Information e-mail: medical.information@bms.com
Medical Information Fax: +44 (0)1895 523 677

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: 09/02/2010
SPC Videx EC 125mg, 200mg, 250mg and 400mg Gastro-resistant Capsules

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 09/02/2010 and displayed until Current
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   10-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Harmonisation with MRP
Updated on 15/10/2008 and displayed until 09/02/2010
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-Aug-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


Retinal or optic nerve changes: Patients on didanosine have demonstratedrarely experienced retinal or optic nerve changes on rare occasionslesions, particularly at doses above those currently recommended. There have been reports of retinal depigmentation. PeriodicTherefore, aAn ophthalmologic examination including visual acuity, color vision, and a dilated retinal examinations shouldfundus examination is to be considered foron a yearly basis as well as in case of occurrence of visual changes, in patients taking Vidextreated with didanosine.

 
Updated on 05/01/2007 and displayed until 15/10/2008
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:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Amendment to sections 4.4 and 4.8 (cross referencing only) of the SmPC to include a statement on the increased risk of pancreatitis (fatal and nonfatal), hepatic events (fatal and nonfatal) and peripheral neuropathy (severe in some cases)  in HIV infected patients receiving didanosine with hydroxyurea and stavudine.
Updated on 21/09/2005 and displayed until 05/01/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 7 - Marketing Authorisation Holder
Updated on 19/09/2005 and displayed until 21/09/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 7 - Marketing Authorisation Holder
  • Pending awaiting re-submission
Updated on 01/06/2005 and displayed until 19/09/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/01/2005 and displayed until 01/06/2005
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 (partial) revision of the text
Updated on 14/06/2004 and displayed until 13/01/2005
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
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/05/2004 and displayed until 14/06/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 23/03/2004 and displayed until 18/05/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/09/2003 and displayed until 23/03/2004
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 (partial) revision of the text
Updated on 21/02/2003 and displayed until 10/09/2003
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/11/2002 and displayed until 21/02/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 28/02/2002 and displayed until 29/11/2002
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 - Pharmacological Properties
Updated on 08/08/2001 and displayed until 28/02/2002
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • 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
  • Change to section 5 - Pharmacological Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/10/2000 and displayed until 08/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  didanosine