Sustiva 50mg and 200mg capsules (efavirenz) - Revised SPC

Source: Manufacturer notification

Date published: 01/02/2010 11:53

Type of SPC Change: Revised SPC

Generic drug name: Efavirenz

Drug brand name: Sustiva

Legal status: POM

Pharmaceutical manufacturer: Bristol-Myers Squibb Pharmaceuticals Ltd

Summary
by: Clare Greenwood

Section 4.5 (Interaction with other medicinal products and other forms of interaction) has been updated with information on the use of efavirenz and anticoagulants:
Warfarin/Efavirenz Interaction not studied. Plasma concentrations and effects of warfarin are potentially increased or decreased by efavirenz. Dose adjustment of warfarin may be required.

Section 4.8 (Undesirable effects) has been updated to include flushing, tinnitus and tremor in the post-marketing experience paragraph.

SPC

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