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sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 01/09/2010
SPC Trental Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   31-Aug-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Change to section 6.3 - Shelf Life - Reduction in shelf life
Updated on 20/07/2010 and displayed until 01/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   31-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
 

Change to Section 4.4, Special warninga and special precautions for use

Change to Section 4.5 Interactions with other medicinal productions and other forms of Interaction

Change to Section 4.8 Undesirable effects
Updated on 16/07/2010 and displayed until 20/07/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   31-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
updates to sections:
4.4: update to include; reference to analyphyactic/ analphylatic reactions & information relating to concurrent use with Vitamin K
4.5: Updated to include: reference to recommendation that patients under medication for diabetes be carefully monitored & information relating to concurrent use with Vitamin K
4.8: update in accordance with MEDRA classification
Updated on 03/10/2008 and displayed until 16/07/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 13/05/2008 and displayed until 03/10/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section
4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3 of SPC
Updated on 04/09/2007 and displayed until 13/05/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 13/12/2006 and displayed until 04/09/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section -
1 - Product tradename
7 - Change MAH to sanofi aventis Ireland Ltd.
10 - Date of revision
Updated on 08/12/2003 and displayed until 13/12/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 25/06/2003 and displayed until 08/12/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Pentoxifylline