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Notice on the Changes in the Safety Content of the Instructions for Use of Fu'an Granules
author:Quality Assurance Department
time:2026-02-03
browse:13472
<p style="text-indent: 2em; text-align: left;">In order to better guide clinical safe and rational drug use, our company, in accordance with the requirements of the announcement (No. 20 of 2023) issued by the National Medical Products Administration regarding the "Special Provisions for Drug Registration Management of Traditional Chinese Medicine", has actively carried out a market research on the safety information items of Fu'an Granules. We have revised the contents of the instructions and labels [adverse reactions], [precautions], and [cautions] and completed the supplementary application. To ensure that patients fully understand the revised information in the instructions, and to facilitate their use, we will inform them of the changes in the form of a notification letter on our company's official website. </p><p style="text-indent: 2em; text-align: left;">I. The changes in the instruction manual are as follows: </p><p style="text-indent: 2em; text-align: left;">(1). 【Adverse Reactions】 It has been changed to "The ingredients contained in this product may cause adverse reactions such as rash, itching, and allergic reactions." </p><p style="text-indent: 2em; text-align: left;">(2). 【Precautions】 Have been changed to "1. Pregnant women are prohibited from using. 2. Those who are allergic to this product or its components are also prohibited from using." </p><p style="text-indent: 2em; text-align: left;">(III). [Notes] The indication has been changed to "1. Caution for those with impaired liver or kidney function." </p><p style="text-indent: 2em; text-align: left;">2. Caution is advised for patients with diabetes. </p><p style="text-indent: 2em; text-align: left;">3. Elderly or weak individuals should use with caution. </p><p style="text-indent: 2em; text-align: left;">4. This product should not be used in excessive amounts or for an extended period. </p><p style="text-indent: 2em; text-align: left;">"Use of this product is prohibited if its properties change." </p><p style="text-indent: 2em; text-align: left;">II. The revised content of the manual is applicable to our company's Abian Granules in the market circulation and will not affect the normal use of the medicine. </p><p style="text-indent: 2em; text-align: left;">III. If the medicine purchased by the patient is the original unmodified one, the updated instructions can be obtained from the pharmacy or hospital where the purchase was made. If for any reason it is impossible to obtain the updated instructions, please contact our company according to the following phone number. Our company can provide the updated paper version of the 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 Traditional Chinese Medicine Factory Co., Ltd. </p><p style="text-indent: 2em; text-align: left;">December 19th, 2025</p>
关于芪枣颗粒说明书安全性内容变更的告知函
12-11-2025
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 la
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关于补肾益精丸说明书安全性内容变更的告知函
04-13-2026
为更好地指导临床安全用药、合理用药,我司根据国家药品监督管理局发布《中药注册管理专门规定》的公告(2023年第20号)要求,主动开展补肾益精丸安全性信息项上市研究,变更说明书及标签【不良反应】、【禁忌】和【注意事项】内容并完成补充申请。为使患者充分知悉说明书的修订情况,方便患者使用,我司将变更情况以告知函的形式在公司官方网站予以告知。
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