WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) Ver el documento en el formato PDF
Índice de contenido
Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoACETYLSALICYLIC ACID - MHRA confirms labelling change
Ver el documentoACITRETIN - Warnings of depression added to label
Ver el documentoASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
Ver el documentoCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
Ver el documentoDIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
Ver el documentoHUA FO - Presence of tadalafil
Ver el documentoIODINE - Some products contain more than the RDA
Ver el documentoLEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
Ver el documentoLINDANE - Additional warnings and medication guide added to label
Ver el documentoNEFAZODONE - Regulatory status update
Ver el documentoNIMESULIDE - Paediatric preparations banned in Bangladesh
Ver el documentoPERGOLIDE MESYLATE - Risk of cardiac valvulopathy
Ver el documentoREPAGLINIDE - Contraindicated with gemfibrozil
Ver el documentoRISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
Ver el documentoTELITHROMYCIN - Aggravation of myasthenia gravis
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoCURRENT CONCERNS
Abrir esta carpeta y ver su contenidoDRUGS OF INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
 

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.

Reference:
Drug Info Zone, UK Medicines Information Service, 28 May 2003. Available from URL: http://www.druginfozone.nhs.uk

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