Summary of Product Characteristics
last updated on the eMC:
07/07/2009
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 07/07/2009 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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| Date of revision of text on the SPC: 01-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of interstitial lung disease to section 4.4 and 4.8
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Updated on 16/09/2008 and displayed until 07/07/2009
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 22-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8: The following information has been added
Hepato-biliary disorders
Very common: abnormal liver function tests*. Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued. These increases could be associated with jaundice. In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section 4.4)
Not known: hepatitis
* study data indicate that Asian patients may be more susceptible to liver function test abnormalities - 3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.
Section 5.28: The following information has been added
Race: a clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf. 0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite. The clinical significance of these results is not known.
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Updated on 20/09/2006 and displayed until 16/09/2008
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Change to section 9 - Date of Renewal of Authorisation
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| Date of revision of text on the SPC: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Licence renewal date of July 2006 added.
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Updated on 01/08/2006 and displayed until 20/09/2006
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Change to section 4.6 - Pregnancy and Lactation
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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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| Date of revision of text on the SPC: 12/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.6 - Animal data on use in pregnancy and lactation has been moved to section 5.3, all information remains the same
Section 4.8 - Addition of hepatitis as very rare side effect
Section 4.9 - Amended to include further details on overdose
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Updated on 16/09/2005 and displayed until 01/08/2006
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Change to section 10 (date of (partial) revision of the text
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Updated on 08/01/2003 and displayed until 16/09/2005
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Change to section 5.2 - Pharmacokinetic Properties
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Updated on 14/01/2002 and displayed until 08/01/2003
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Change to section 6. 3 - Shelf Life
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Updated on 23/08/2001 and displayed until 14/01/2002
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Transferred from eMC version 1
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Updated on 22/03/2001 and displayed until 23/08/2001
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Updated on 30/10/2000 and displayed until 22/03/2001
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Updated on 10/10/2000 and displayed until 30/10/2000
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Updated on 06/09/1999 and displayed until 10/10/2000
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