Feilike mixture (capsule) revision of drug instructions increased nausea, abdominal pain and other adverse reactions

2022-06-23 0 By

Beijing News (Reporter Zhang Xiulan) On January 28, the State Food and Drug Administration (SDA) issued a notice to revise the drug instructions of Feili Cough mixture (capsule), adding nausea, vomiting and other adverse reactions.Guizhou Jianxing Pharmaceutical Co., Ltd. is the sole manufacturer of the drug.The state Food and Drug Administration (SFDA) said it decided to revise the “and” in the instructions of Feilike Mixture (capsules) based on the results of an assessment of adverse drug reactions.Among them, items should include: Monitoring data show that the product can see the following adverse reactions: nausea, vomiting, dry mouth, diarrhea, abdominal pain, abdominal distension, abdominal discomfort, gastrointestinal reactions, rash, itching, flushing, allergic reactions, etc.Add “Contraindicated in case of hypersensitivity to this product and its contents”.Guizhou Jianxing Pharmaceutical Co., Ltd. is the only manufacturer of Feili Cough mixture, according to the website of the State Food and Drug Administration. It has workshops for TCM extraction, granule, capsule, mixture, dropping pill and gel, and feili cough mixture (capsule) is its patented product.According to the SFDA, all drug marketing license holders should submit supplementary applications to the provincial drug regulatory authorities for filing before April 24, 2022 in accordance with the requirements of the revised specifications (see attachment) in accordance with the relevant provisions of the Drug Registration Administration measures and other regulations.Proofreading liu Baoqing