Patient information leaflet (PIL) or package insert is a summarized, patient-oriented version of Summary of Product Characteristics (SPC).
PIL is a digital or printed document featuring specific information on medical conditions, doses, side effects and other medical product details that can be easily understood by patients and users of medical products.
Patient information leaflets are composed by manufacturing companies and delivered with the medical products.
Designed to convey the accurate pharmaceutical data in a manner clear to common users, PILS are translated and localized by experienced multidisciplinary expert teams with the required skills for clear, concise and accurate adaptation of medical and pharmaceutical content to a foreign market.
All PILs at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.