Zerit 20mg, 30mg, 40mg capsules (stavudine) - Revised SPC

Source: Manufacturer notification

Date published: 01/02/2010 12:08

Type of SPC Change: Revised SPC

Generic drug name: Stavudine

Drug brand name: Zerit

Legal status: POM

Pharmaceutical manufacturer: Bristol-Myers Squibb Pharmaceuticals Ltd

Summary
by: Clare Greenwood

Section 4.8 Undesirable effects has been updated.
A paragraph concerning motor weakness is included:
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.

In the postmarketing section, anaemia and neutropenia are listed under blood and lymphatic system disorders, and diabetes mellitus and hyperglycaemia are listed under metabolic and nutrition disorders.

SPC

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