四川在线记者 魏冯 近日，国家药品监督管理局决定对孟鲁司特制剂（包括孟鲁司特钠片、孟鲁司特钠咀嚼片、孟鲁司特钠 颗粒和孟鲁司特钠口溶膜）说明书内容进行统一修订。警示语方面，说明书修订建议应包含以下内容： 在服用孟鲁司特的各年龄段患者中均报告了神经精神不良反应，其中包括个别严重反应如抑郁和自杀倾 向等。 用药期间需密切看护患者，应详细告知医生既往神经或精神系统相关病史 应对国家药品监督管理局要求增加的相关警示语，重点在于用药过程中的监测与观察。赵艳分析，本次 公告提示的精神系统紊乱包括攻击性行为或敌对性的兴奋、焦虑、抑郁、方向知觉丧失、注意力不集 中、夜梦异常、口吃（结巴）、幻觉、失眠、记忆损伤、精神运动过激（包括易激惹、烦躁不安和震 颤）、梦游、自杀的想法和行为（自杀）、抽搐；神经系统紊乱包括：眩晕、嗜睡、感觉异常触觉减退 及罕见的癫痫发作。 用药期间，家属或家长需密切看护，时刻关注患者的情绪和行为变化，注意有无上述异常情况出现，以 及异常情况的出现与服药有无时间关系。一旦出现疑似神经精神相关不良反应，应及时告知医生并评估 停药，必要时调整治疗方案。 赵艳还提醒，儿童使用孟鲁司特前，家长应详细告知医生既往是否 ...

修订书建议中提出，新版"警示语"中应包括，在服用孟鲁司特的各年龄段患者中均报告了神经精神不良 反应，其中包括个别严重反应如抑郁和自杀倾向等；若不停药，这些症状可能持续存在。在孟鲁司特治 疗期间如出现神经精神症状，应停药并就医。建议患者或看护人警惕神经精神不良反应，在用药期间出 现相关症状时应告知医师。 近日，国家药监局官网发布公告称，根据药品不良反应评估结果，为进一步保障公众用药安全，国家药 监局决定对孟鲁司特制剂（包括孟鲁司特钠片、孟鲁司特钠咀嚼片、孟鲁司特钠颗粒和孟鲁司特钠口溶 膜）说明书内容进行统一修订。 ...

《问药师》创始人冀连梅在社交平台发文指出，孟鲁司特钠并非过敏性鼻炎、哮喘治疗首选药物，儿童 出现脾气暴躁、注意力异常等精神副作用的比例更高，无论成人还是儿童，用药期间一旦出现神经精神 相关症状，需立即停药就医，用药前务必充分评估获益与风险。 （文章来源：北京商报） 修订建议提到，警示语应包含：在服用孟鲁司特的各年龄段患者中均报告了神经精神不良反应，其中包 括个别严重反应如抑郁和自杀倾向等；若不停药，这些症状可能持续存在。在孟鲁司特治疗期间如出现 神经精神症状，应停药并就医。建议患者或看护人警惕神经精神不良反应，在用药期间出现相关症状时 应告知医师。同时要求在不良反应的上市后经验中添加口吃（结巴）。 12月22日，国家药监局发布公告，对孟鲁司特制剂（包括孟鲁司特钠片、孟鲁司特钠咀嚼片、孟鲁司特 钠颗粒和孟鲁司特钠口溶膜）说明书内容进行统一修订。 ...

《问药师》创始人冀连梅在社交平台发文指出，孟鲁司特钠并非过敏性鼻炎、哮喘治疗首选药物，儿童 出现脾气暴躁、注意力异常等精神副作用的比例更高，无论成人还是儿童，用药期间一旦出现神经精神 相关症状，需立即停药就医，用药前务必充分评估获益与风险。 北京商报讯（记者 王寅浩 宋雨盈）12月22日，国家药监局发布公告，对孟鲁司特制剂（包括孟鲁司特 钠片、孟鲁司特钠咀嚼片、孟鲁司特钠颗粒和孟鲁司特钠口溶膜）说明书内容进行统一修订。 修订建议提到，警示语应包含：在服用孟鲁司特的各年龄段患者中均报告了神经精神不良反应，其中包 括个别严重反应如抑郁和自杀倾向等；若不停药，这些症状可能持续存在。在孟鲁司特治疗期间如出现 神经精神症状，应停药并就医。建议患者或看护人警惕神经精神不良反应，在用药期间出现相关症状时 应告知医师。同时要求在不良反应的上市后经验中添加口吃（结巴）。 ...

公告明确，药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药 品使用和安全性问题的宣传培训，指导医师、药师合理用药。临床医师、药师应当仔细阅读上述药品说 明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。 省级药品监督管理部门应当督促行政区域内上述药品的上市许可持有人按要求做好相应说明书修订 和标签、说明书更换及说明书更新信息的告知工作，对违法违规行为依法严厉查处。 国家药监局提醒，患者用药前应当仔细阅读药品说明书，使用处方药的，应当严格遵医嘱用药。 人民网北京12月22日电 （记者孙红丽）国家药监局今日发布公告，根据药品不良反应评估结果， 为进一步保障公众用药安全，国家药监局决定对孟鲁司特制剂（包括孟鲁司特钠片、孟鲁司特钠咀嚼 片、孟鲁司特钠颗粒和孟鲁司特钠口溶膜）说明书内容进行统一修订。 根据公告，所有上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照附 件要求修订说明书，于2026年3月12日前报国家药监局药品审评中心或省级药品监督管理部门备案。 修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在 ...

Group 1 - Company has received the approval notice for the supplementary application of the drug "Xiaolin Baidu San" from the National Medical Products Administration [1] - "Xiaolin Baidu San" is a unique product of the company, primarily used for clearing heat and detoxifying, and treating symptoms related to urinary tract infections [1] - The company has invested approximately 28.15 million RMB in research and development for "Xiaolin Baidu San" and its pill form [1] Group 2 - The company has obtained a change in its drug production license from the Shandong Provincial Drug Administration, allowing for the addition of workshops, production lines, and production scope [4] - The production license now includes the addition of a comprehensive preparation workshop for pill production, enhancing the company's production capabilities [5] - The extension of the entrusted production validity period for various medications will help maintain stable production capacity and meet market demand [6]

Core Viewpoint - Company has received approval from the Shandong Provincial Drug Administration to expand its production capabilities, which is expected to positively impact its future operations [1] Summary by Sections Production License Update - The company has been granted permission to add a new workshop and production line for the production of tablets, specifically in the Heze City location [1] - The new workshop added is the Comprehensive Preparation VI workshop, which will focus on tablet production [1] Contract Manufacturing Extensions - The company has extended its contract manufacturing agreements for various products: - Loratadine tablets and Montelukast chewable tablets until July 16, 2028 - Ibuprofen sustained-release capsules and Ezetimibe tablets until July 16, 2028 - Pregabalin capsules until March 31, 2028 - Donepezil hydrochloride tablets until July 7, 2030 [1] Impact on Operations - The changes in the production license, including the addition of workshops and production lines, are expected to optimize the company's production structure [1] - This will help maintain stable production capacity and meet market demand, leading to a positive impact on the company's future operations [1]

Group 1 - The company is a leading player in the traditional Chinese medicine patch industry, with a stable growth in performance, achieving a revenue of 3.501 billion yuan in 2024 (+5.72%) and a net profit of 723 million yuan (+27.19%) [1] - In Q1 2025, the company reported a revenue of 1.021 billion yuan (+12.29%) and a net profit of 217 million yuan (+13.89%) [1] - The core products showed steady growth, with revenues from patches, tablets, capsules, ointments, and other categories reaching 2.115 billion, 356 million, 752 million, 128 million, and 148 million yuan respectively, with year-on-year growth rates of +3.35%, +35.60%, +5.66%, -7.09%, and -1.20% [1] Group 2 - The company has a strong market presence in external traditional Chinese medicine patches, with annual sales of the Tongluo Pain Relief Patch exceeding 1 billion yuan and the "Two Tigers" series products selling over 1 billion patches annually [1] - The company’s R&D expense ratio for 2024 was 3.76% (+0.45 percentage points), focusing on major diseases and products in orthopedics, respiratory, skin, and digestive systems [2] - The company signed a letter of intent for acquisition with Yingu Holdings Group in December 2024, aiming to acquire a controlling stake in Yingu Pharmaceutical, which aligns with its strategic planning and enhances its product matrix with high-tech nasal sprays and inhalants [2] Group 3 - The company expects net profits for 2025-2027 to be 831 million, 932 million, and 1.056 billion yuan, representing year-on-year growth of +15.0%, +12.2%, and +13.4% respectively [2] - The company maintains a leading brand advantage in the traditional Chinese medicine patch sector, with a solid market share for multiple products, and continues to enhance its product matrix through R&D and acquisitions [2]