príbalový

Príbalový is a term used in Czech and Slovak pharmaceutical language to describe materials that accompany a medicinal product. The most common use is with the phrase príbalový leták, or package leaflet, which is the patient information leaflet included in the packaging. This leaflet provides essential information to help patients use a medicine safely and effectively.

Regulatory and scope context: In the European Union, medicines placed on the market must be accompanied by a patient information leaflet and related packaging insert. The leaflet is typically derived from the medicine’s Summary of Product Characteristics and translated into the local language. Its purpose is to convey clear, practical guidance to patients and caregivers, alongside the technical SmPC used by healthcare professionals.

Content and structure: A typical príbalový leták covers what the medicine is used for, how to use it (dosage and administration), warnings and precautions, potential drug interactions, possible side effects, pregnancy and lactation considerations, storage instructions, and the date of the last revision. It is designed to be accessible to lay readers and to supplement the professional information found in the SmPC.

Format and updates: Leaflets are commonly printed as a folded sheet or small booklet inside the medicine packaging. They are updated whenever the SmPC is revised or new safety information becomes available, and new language versions must be added to reflect regulatory requirements in each country.

Role and usage: The príbalový leták serves as a primary source of patient-facing information, supporting informed use, adherence, and safety. The term príbalový, in this context, distinguishes packaging-related information from other regulatory or technical documents associated with a medicinal product.