ANALYSIS OF THE MEDICINE PACKAGE LEAFLETS CONTAINING GINKGO BILOBA L. MARKETED IN PATOS DE MINAS, MINAS GERAIS, BRAZIL

Abstract

Industrialized medicines prepared from the dry extract of Ginkgo biloba L. are found in community pharmacy mainly in the forms of capsules and tablets. In acquiring the industrialized medicine, users have the package insert as the main source of printed information and for this information fulfill their purpose, it must be presented in an objective, updated and complete way. Thus, the objective of the study was to analyze the medicine package inserts containing dry extract of Ginkgo biloba L. according to the standards required by Brazilian normative RDC n. 47/2009 of Brazilian Health Surveillance Agency. An
observational study was conducted with analysis of phytomedicines package inserts containing dry extract of Ginkgo biloba L. as single drug in the pharmaceutical form of capsules or tablets, sold in communitarian pharmacies in the city of Patos de Minas in Brazil, considering the topics: Identification of the product, Information for the patient, Legal information and Mandatory
statements. Of the total different pharmaceutical specialties found, two did not have their respective package insert. In 45% of package inserts, some of the Mandatory statements were absent. One package insert brought conflicting information about the actual physical aspect of medicine. About the topic Information to patients, 48% of the package inserts were incomplete, and
among these, with indications not established by law. All package inserts had complete information relating to topics Legal information and Identification of the product. Even under specific legislation, there are still phytomedicines with their package insert out of the established standards. The package inserts may have their primary function diverted when they cease to be an
educational and informational material and become a source of confusion and incentive to misuse.