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.