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Comparison of the Summary of Product Characteristics of Levocetirizine 5 mg According to Safety Criteria for Rational Drug Use

Ozaydin N, Ozaydin AN

Background: Anti-histamine drugs (AHDs) are employed for the treatment of allergic diseases. Second-generation AHDs such as levocetirizine is preferred today because they have fewer side effects than first-generation AHDs. Methods: Content of the Summary of Product Characteristics (SPC) of levocetirizine (5 mg) approved by Health Authority of Turkey (HAT), US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were compared to ascertain if there were differences according to safety criteria of rational drug use (RDU). Results: The SPC of levocetirizine (5 mg) was prepared mainly by using information of the SPC from the EMA as a reference. However, some more vital safety features are present in the SPC from the FDA. Using the properties of the SPC from the FDA will be useful during preparation of the SPC for approval from the HAT with respect to the safety criterion of RDU.