步長製藥(603858.SH)修訂腦心通製劑説明書中的不良反應及禁忌
格隆匯4月13日丨步長製藥(603858.SH)公佈,為進一步保障公眾用藥安全,國家藥品監督管理局於2020年4月10日公佈了《國家藥監局關於修訂腦心通製劑説明書的公告》(2020年第51號)。公告要求對腦心通製劑(包括片劑、膠囊劑、丸劑)説明書【不良反應】、【禁忌】和【注意事項】項進行統一修訂,並按規定於2020年6月30日前報省級藥品監管部門備案。
腦心通製劑説明書修訂要求如下:
【不良反應】項應增加:監測數據顯示,腦心通製劑可見以下不良反應:噁心、嘔吐、腹脹、腹痛、腹瀉、腹部不適、便祕、口乾、頭暈、頭痛、皮疹、瘙癢、心悸、呼吸困難、潮紅、過敏反應等。
【禁忌】項應增加:對本品及所含成份過敏者禁用。
【注意事項】項應增加:1.本品建議飯後服用。2.有出血傾向、行經期婦女或使用抗凝、抗血小板治療的患者慎用。3.脾胃虛弱者及過敏體質者慎用。4.不宜與藜蘆同用。
腦心通膠囊主治功能為:益氣活血,化瘀通絡。用於氣虛血滯、脈絡瘀阻所致中風中經絡,半身不遂、肢體麻木、口眼歪斜、舌強語謇及胸痺心痛、胸悶、心悸、氣短;腦梗塞、冠心病心絞痛屬上述證候者。
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