CRED SMPC 2024

Additional concepts to improve risk communication in PILs

Headlines • To improve access to key information

Guidance on the description of risk/safety advice • Order, format, words, and numbers

Risk in the context of Benefit • To provide overall balance

49

49

Headlines

• Short list of the most important things for patient/user to know

• Presented at the beginning of leaflet as bullet points

• Not a substitute for reading the rest of the PIL

• Only include key messages on safe and appropriate use

50

50

25