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关于芪枣颗粒说明书安全性内容变更的告知函
author:Quality Assurance Department
time:2025-12-11
browse:757
<p style="text-indent: 2em; text-align: left;">Notice of Changes to the Safety Information in the Instructions for Qizao Granules </p><p style="text-indent: 2em; text-align: left;">In order to better guide the safe and rational use of drugs in clinical practice, our company, in accordance with the requirements of the "Special Provisions on the Registration Management of Traditional Chinese Medicine" announced by the National Medical Products Administration (No. 20, 2023), has proactively conducted post-marketing research on the safety information of Qizao Granules, revised the contents of "Adverse Reactions", "Contraindications" and "Precautions" in the instructions and labels, and completed the supplementary application. To ensure that patients are fully informed of the revision of the instructions and facilitate their use, our company has informed the changes in the form of a notice on the company's official website. </p><p style="text-indent: 2em; text-align: left;">The changes to the instruction manual are as follows: </p><p style="text-indent: 2em; text-align: left;">(1) [Adverse Reactions] Changed to: "The following adverse reactions may occur with this product: nausea, dry mouth, hot flushes, dizziness, insomnia, nosebleeds, allergic reactions, etc." </p><p style="text-indent: 2em; text-align: left;">(II) [Contraindications] are changed to "1. Those with yin deficiency and internal heat are prohibited from using. 2. Those allergic to this product and its ingredients are prohibited from using." </p><p style="text-indent: 2em; text-align: left;">(3) Precautions: 1. Patients with exogenous diseases and bleeding should not use it. </p><p style="text-indent: 2em; text-align: left;">Diabetic patients should use with caution. </p><p style="text-indent: 2em; text-align: left;">3. People with allergic constitutions should use with caution. </p><p style="text-indent: 2em; text-align: left;">4. Do not use this product if its appearance changes. </p><p style="text-indent: 2em; text-align: left;">The revised content of the instructions is applicable to the Qizao Granules currently in circulation in the market by our company and will not affect the normal use of the medicine. </p><p style="text-indent: 2em; text-align: left;">III. If the patient has purchased the drug with the unaltered instructions, they can obtain the updated instructions through the pharmacy or hospital where they purchased the drug. If for any reason they are unable to obtain them, please contact our company at the following phone number, and we can provide the updated paper instructions. If you have any other questions, please feel free to call us. (Contact Number: 0592-7266588) </p><p style="text-indent: 2em; text-align: left;">This is to inform you! </p><p style="text-indent: 2em; text-align: left;">Xiamen Chinese Medicine Factory Co., Ltd. </p><p style="text-indent: 2em; text-align: left;">December 3, 2025</p>
Notice on the Change of Safety Content in the Manual of Da Qili SAN
11-03-2025
Notice on the Change of Safety Content in the Manual of Da Qili SAN
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