Summary of Product Characteristics
last updated on the eMC:
12/05/2008
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 12/05/2008 and displayed until Current
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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 4.8 - 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: 02-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
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Free-text change information supplied by the pharmaceutical company
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Section 4.4
Elevations in serum transaminases can occur during treatment with ‘Accolate’. These are usually asymptomatic and transient but could represent early evidence of hepatotoxicity, and have very rarely been associated with more severe hepatocellular injury, fulminant hepatitis and liver failure, some of which resulted in a fatal outcome. (see section 4.8). In extremely rare post-marketing cases, no prior clinical symptoms or signs suggestive of liver dysfunction preceded the severe hepatic injury. Extremely rarely, cases of fulminant hepatitis and liver failure have been reported in patients in whom no previous clinical signs or symptoms suggestive of liver dysfunction were reported.
Section 4.8
Hepatobiliary: Symptomatic hepatitis with and without hyperbilirubinaemia (rare), hyperbilirubinaemia, without elevated liver function tests (rare), hepatic failure (very rare),and fulminant hepatitis, sometimes with a fatal outcome (see section 4.4) (very rare)
Section 10
Date changed to 2nd May 2008
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Updated on 17/12/2004 and displayed until 12/05/2008
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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 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/08/2004 and displayed until 17/12/2004
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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 4.8 - Undesirable Effects
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Updated on 05/12/2002 and displayed until 24/08/2004
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 29/11/2001 and displayed until 05/12/2002
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Change to section 7 - Marketing Authorisation Holder
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Updated on 20/07/2001 and displayed until 29/11/2001
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Removal of Black Triangle
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Updated on 20/06/2001 and displayed until 20/07/2001
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Updated on 28/07/2000 and displayed until 20/06/2001
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Updated on 06/09/1999 and displayed until 28/07/2000
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