Summary of Product Characteristics
last updated on the eMC:
15/06/2011
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 15/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.8 of the SPC to include meningitis aseptic,
arrhythimia, epigastric discomfort, abdominal distension and anaphylactic
reactions as additional adverse reactions, to bring the SPC in line with the
Company Core Safety Information and to update the adverse reactions to
include System Organ Classification and MedDRA terms.
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Updated on 31/01/2011 and displayed until 15/06/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 25-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Special warnings and precautions for use
Addition of: -
At the first signs of an anaphylactic/anaphylactoid reaction, Trental 400 must be discontinued or the infusion must be halted immediately, and a physician must be informed.
Particular careful monitoring is required:….
and
In patients treated concomitantly with pentoxifylline and anti-vitamin K (see also section 4.5).
In patients treated concomitantly with pentoxifylline and antidiabetic agents (see also section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Addition of: -
It is recommended that patients under medication for diabetes mellitus be carefully monitored.
Post-marketing cases of increased anti-coagulant activity have been reported in patients concomitantly treated with pentoxifylline and anti-vitamin K. Monitoring of anti-coagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
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Updated on 12/09/2007 and displayed until 31/01/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
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Updated on 16/08/2005 and displayed until 12/09/2007
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 25/02/2003 and displayed until 16/08/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 06/09/1999 and displayed until 25/02/2003
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Reasons for adding or updating:
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