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January 6, 2026
Approximately 5 minutes
AEMPS Guidance on Medicines and Safe Driving in Spain
AEMPS Guidance on Medicines and Safe Driving in Spain
1. Introduction and Importance
Certain medicines can cause adverse reactions such as drowsiness, dizziness, or reduced reflexes that impair the ability to drive or operate dangerous machinery. The Spanish Agency for Medicines and Medical Devices (AEMPS) ensures that authorized medicines include necessary information for safe use, particularly regarding effects on driving.
AEMPS Medicamentos y conducción
2. Evaluation and Warnings in Package Leaflets
For every authorized medicine, potential effects on driving and operating machinery are evaluated. If applicable, specific warnings are included in the package leaflet (prospecto) in a dedicated section.
AEMPS Medicamentos y conducción
3. Warning Pictogram on Packaging
Medicines that may reduce driving capacity must display a warning pictogram on the outer packaging (cartonaje). This requirement stems from Real Decreto 1345/2007, with implementation required before 2011.
The pictogram alerts users that the medicine may affect the ability to drive or operate machinery.
AEMPS Medicamentos y conducción
4. Active Substances Requiring the Pictogram
Information on active substances necessitating the pictogram is published progressively on the AEMPS website as therapeutic subgroups are reviewed.
AEMPS Medicamentos y conducción
5. Recommendations for Safe Use
Patients should always read the package leaflet, particularly the section on driving warnings. Healthcare professionals play a key role in informing patients about potential risks.
A consensus document provides further guidance on medicines and driving in Spain.
AEMPS Medicamentos y conducción
6. Additional Resources
For more details, refer to the consensus document on medicines and driving.
Page last updated: February 18, 2017.
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