1. 除了神經精神方面及與尼古丁戒斷綜合症(nicotine withdrawal symptoms)相關的不良反應外, 藥廠在該藥的說明書中新增了以下警告性資料：
- 嚴重過敏反應, 如需要即時治療的罕見致命性血管水腫, 以及包括史提芬-強生綜合症及多形性紅斑在內罕見的嚴重皮膚反應。
- 應避免服用酒精, 因為可能增加出現精神不良作用的風險。
- 如病人出現或家人及照護者察覺到病人出現神經心理症狀﹑不正常或不典型的行為時, 應停止服藥, 並向醫生求診。
- 如病人出現嚴重皮膚反應或過敏症狀, 應立即停止服用varenicline, 並立即就診。
- 該藥可能引起睡意, 應避免進行有潛在危險的活動, 如駕車或操作機器, 直至病人充分了解varenicline對其影響的程度。
Further to our previous safety alerts faxes Nos. 1059/DAF/07 & 0610/DAF/09 on varenicline (Champix®), a smoking cessation medication, recent release from Health Canada identified new safety issues that were not being covered on our last notifications:
1. Apart from neuropsychiatric adverse events and associated nicotine withdrawal symptoms, new warnings include into the package insert of this drug include:
- serious hypersensitivity reactions, such as rare life-threatening angioedema events requiring urgent medical attention and rare severe cutaneous reactions, including Stevens-Johnson syndrome and erythema multiforme.
- somnolence, dizziness, loss of consciousness, seizures or difficulty concentrating.
2. Prescribers, pharmacists and other healthcare professionals should remind their patients prior to and during vaenicline treatment that they should:
- avoid alcohol as this may increase the risk of patients experiencing psychiatric adverse events.
- stop the medication and contact their physician if they experience or if their families or caregivers observe that neuropsychiatric symptoms or abnormal, atypical behaviors that are not normal for the patient.
- stop varenicline immediately and seek emergency medical care if they experience any signs or symptoms of severe skin or hypersensitivity reactions.
- know that this medication may cause drowsiness, avoid engaging themselves in potentially hazardous activities, such as driving a car or operating dangerous machinery until they know how they may be affected by varenicline.
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