In the EU, medicinal products must be accompanied by outer and/or immediate packaging information (labelling) and a Package Leaflet (PL). The PL should be written in language understandable by the patient and must undergo readability testing. It contains:
- What medicine X is and what it is used for (identification of the medicinal product).
- What you need to know before you take/use X (contraindications and warnings and precautions for use: in children and adolescents; with other medicines; with food, drink, or alcohol; in case of pregnancy, breastfeeding, driving, and using machines; and any excipient warnings, if applicable.)
- How to take/use X (dosage and method/route(s) of administration; use in children and adolescents; frequency of administration; duration of treatment; information in case of overdose and/or missing a dose; and any withdrawal effects if applicable).
- Possible side effects of X
- How to store X (storage conditions; expiry date; warnings against using the product after the expiry date; and warnings against visible signs of deterioration, if applicable).
- Contents of the pack and other information (what X contains; what X looks like; contents of the package; pharmaceutical form; physical description; pack sizes; details of the Marketing Authorisation Holder (MAH) and manufacturer; a list of local representatives (all or none); the date on which the PL was approved; and a section on other sources of information – including product-related website for over-the-counter products if applicable).
Product information templates (latest update: June 2015 (version 9.1)) are published on the EMA website.
