(2003; 14 pages)
LEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
UK. Bristol Myers Squibb has revised the Summary of Product Characteristics (SPC) for their levodopa/carbidopa (Sinemet) preparation to include new warnings about somnolence and sudden onset of sleep. The ‘Special Warnings and Precautions for Use’ section (Section 4.4) has been changed to include a warning that states that levodopa has been associated with somnolence and sudden onset of sleep. Patients must be advised to exercise caution and refrain from driving, if affected. A reduction in dose or discontinuation of treatment may be considered. The sections on ‘Effects on ability to drive and use machines’ and ‘Undesirable effects’ (sections 4.7 and 4.8) have been modified to reflect these additions.
Drug Info Zone, UK Medicines Information Service, 28 May 2003. Available from URL: http://www.druginfozone.nhs.uk