Patient Information Leaflet (PIL)
A document written in accessible language included with every medicine that informs patients about the drug's purpose, proper use, side effects, storage, and other essential information. PILs must be consistent with the approved SmPC (EU) or prescribing information (US).
Technical Context
PILs must be written in clear, accessible language (EU readability testing with target patient groups is recommended). Standard PIL sections: what the medicine is and what it is used for, what you need to know before taking it (contraindications, warnings, interactions, pregnancy/lactation), how to take it (dose, administration instructions, duration), possible side effects (listed by frequency: very common ≥1/10, common ≥1/100, uncommon ≥1/1000, rare ≥1/10,000, very rare <1/10,000), and how to store it. For injectable peptide drugs, PILs include illustrated injection instructions (SC injection technique, site rotation, pen device operation, needle disposal). QR codes or URLs linking to video injection guides are increasingly included. PILs are tested for readability with representative patients as part of the marketing authorisation process.