Quality of the package inserts of phytomedicines in Brazil
DOI:
https://doi.org/10.3395/2317-269x.00677Keywords:
Medicine Package Inserts, Phytomedicines, Health Legislation, Health SurveillanceAbstract
The objective of this study was to assess whether the package inserts of industrialized phytomedicines are in line with current Brazilian legislation or not. Forty-one package inserts of phytomedicines containing artichoke, horse chestnut, ginkgo and senna were accessed in the respective proprietary websites and then analyzed. The analysis aimed to verify the presence of items required by the normative RDC 47/2009 and the usage indication, dosage and side effects compared to standard package inserts and to the scientific literature. Quantitative analysis proved that the package inserts are in accordance with the current legislation. However, in qualitative analysis, all phytomedicines analyzed in this study had at least one error related to dosage, posology or adverse reactions. A gradual improvement of the package inserts of phytomedicines has been noticed but, even with the availability of standard package inserts, some mistakes persist, which can induce the patient to incorrect use.Downloads
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