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