Packungsbeilage

Packungsbeilage, commonly translated as patient information leaflet, is the informational document included with a medicinal product in German-speaking markets. Its primary purpose is to provide patients and caregivers with clear, practical guidance for safe and effective use, and how to store, use, and dispose of the medicine. It serves as a lay-oriented companion to the more technical professional labeling.

The leaflet lists essential details such as the product name and active substances, indications for use, recommended dosage and method of administration, duration of treatment, contraindications, warnings and precautions, interactions with other medicines or foods, and advice for special populations (pregnancy, breastfeeding, children, elderly). It also covers possible side effects, symptoms of overdose, what to do in case of adverse reactions, and information on storage conditions, expiry, and disposal. Excipients and packaging details are provided where relevant, along with the name and contact information of the marketing authorization holder and the medicines’ registration number. Sections are tailored to patient comprehension and may be presented in multiple languages.

Regulatory context: in the European Union and Germany, the pack insert is mandatory and must comply with EU pharmacovigilance and labeling rules; it is prepared by the marketing authorization holder and approved by the competent national authority. Updates are issued when new safety information arises. In practice, the Packungsbeilage may be provided as a paper leaflet inside the box and, increasingly, as a digital version via QR code or online portal.