Package Leaflet

What is Package Leaflet?

Package Leaflet definition and meaning on Health terms:
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(. . . )

 

reference: https://www.eupati.eu/glossary/

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