A Chinese translation 中文翻译 of this information is available below.
Consumers and health professionals are advised that Shen Neng Herbal Medicines Group, in consultation with the TGA, is recalling all batches of Jin Gui Shen Qi Wan - 金 匮 肾 气 丸 - (AUST L 217716) due to potential toxicity.
Jin Gui Shen Qi Wan pills are a complementary medicine used in traditional Chinese medicine, and are marketed to help or treat various complaints including mild bronchitis.
Samples of Jin Gui Shen Qi Wan pills tested by the TGA have been found to contain levels of aconitum alkaloids that are higher than the limit permitted for a listed medicine. These substances can pose an unacceptable risk to health.
Aconitum alkaloids are toxic to humans. Poisoning with these compounds may affect the heart, the nervous system and the gastrointestinal system. Children are particularly at risk, as toxicity can occur at normal doses of Jin Gui Shen Qi Wan pills. An accidental overdose could be fatal in a small child.
Information for consumers
If you or someone you provide care for takes Jin Gui Shen Qi Wan pills, stop taking them and return any unused pills to the place of purchase for a refund.
Potential signs or symptoms of aconitum alkaloids poisoning include:
- low blood pressure, palpitations, chest pain, abnormal heart rhythm
- tingling or numbness in the face or limbs, muscle weakness
- nausea, vomiting, abdominal pain, diarrhoea.
If you have taken Jin Gui Shen Qi Wan pills and experience any of the above symptoms, seek medical attention or call the Poisons Information Centre on 13 11 26.
If you have any questions or concerns about this issue, talk to your health professional.
Information for health professionals
Please be aware of the above issue and advise patients accordingly if they seek advice.
If you have any questions or concerns about this issue, contact Shen Neng Herbal Medicines Group on 02 9416 9831.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
金匮肾气丸
(口服丸)
召回 - 潜在毒性
消费者和健康专业人士请注意, 由于潜在毒性的原因，神农有限公司与澳大利亚治疗产品管理局(TGA)经协商，现在召回所有批号的金匮肾气丸(注册号AUST L 217716)
金匮肾气丸是一味传统中成药, 用于帮助或治疗多种病症，包括轻度支气管炎。
金匮肾气丸样品
治疗产品管理局抽样检测发现，金匮肾气丸所含乌头生物碱水平超过在列药物的许可限度。这些物质可能对健康造成不可接受的风险。
乌头生物碱对人体有毒。这类化合物中毒可能影响心脏，神经和胃肠道系统。对儿童尤其危险，即使正常剂量的金匮肾气丸也可能产生毒性。幼儿一次意外服用过量即可致命。
消费者信息
如果您或您提供护理的人服用金匮肾气丸，请停止服用并将未服用的药丸退回购买地点退款。
乌头生物碱中毒可能出现以下症状或体征：
- 低血压，心悸，胸痛，心律失常
- 面部或肢体麻木，肌肉无力
- 恶心，呕吐，腹痛，腹泻
如果您已服用金匮肾气丸，并且出现任何上述症状，请就医或致电13 11 26毒药信息中心。
如果您对此问题有任何疑问或疑虑，请咨询您的健康专业人士。
健康专业人士信息
请注意上述问题并据此向寻求您意见的患者提供建议。
如果您对此问题有任何疑问或疑虑，请致电02 9416 9831联系神农有限公司。
报告问题
治疗产品管理局鼓励消费者和健康专业人士报告药物或疫苗的问题。您的报告将有助于我们对这些产品的监控。
治疗产品管理局无法就个人的疾病状况提供建议。如果您担心可能与药物或疫苗相关的不良反应事件，强烈建议您向健康专业人士咨询。
