“…It is compulsory for pharmaceutical companies in the European Union to provide data concerning the effects of each medication on patients' ability to drive and use machines, prior to commercialisation (Summary of Product Characteristics, Section 4.7) (ECD, 1983) The insert provided in a medicine's packaging (ECD, 1983) contains information warning of the possible effects patients may notice when driving or handling dangerous machinery, since there is ample evidence that some of the adverse reactions to medications (somnolence, dizziness, blurred vision) may considerably reduce fitness to drive and increasing the risk of involvement in accidents (Orriols et al, 2009(Orriols et al, , 2010Engeland et al, 2007). However, not all users of a medicine read the package insert (Bernardini et al, 2000;Nathan et al, 2007), and many users do not consider the package insert to be very comprehensible (Barrio-Cantalejo et al, 2008).…”