Summary of Product Characteristics
last updated on the eMC:
25/01/2010
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 25/01/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 30-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
SUMMARY OF PRODUCT CHARACTERISTICS
4.8 Undesirable effects
(..........)
Lactic acidosis: cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues (see section 4.4).
Motor weakness has been reported rarely in patients receiving combination antiretroviral therapy including Zerit. Most of these cases occurred in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome (see section 4.4). The evolution of motor weakness may mimic the clinical presentation of Guillain-Barré syndrome (including respiratory failure). Symptoms may continue or worsen following discontinuation of therapy.
Hepatitis or liver failure, which was fatal in some cases, has been reported with the use of stavudine and with other nucleoside analogues (see section 4.4).
(..........)
Postmarketing
The following events have been reported spontaneously during postmarketing experience:
|
Blood and lymphatic system disorders:
|
Not known: anaemia, thrombocytopenia, neutropenia
|
|
Metabolic and nutrition disorders:
|
Common: asymptomatic hyperlactatemia,
Not known: lactic acidosis, diabetes mellitus, hyperglycaemia
|
|
|
|
|
|
Updated on 29/08/2008 and displayed until 25/01/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|