What is WELLBUTRIN SR?
WELLBUTRIN SR is a prescription medicine used to treat adults with a certain type of depressioncalled major depressive disorder.

Who should not take WELLBUTRIN SR?
Do not take WELLBUTRIN SR if you
• have or had a seizure disorder or epilepsy.
• are taking ZYBAN® (used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRIN® Tablets or WELLBUTRIN XL® Extended-Release Tablets. Bupropion is the same active ingredient that is in WELLBUTRIN SR.
• drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden.
• have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL®*(phenelzine sulfate), PARNATE®(tranylcypromine sulfate), or MARPLAN®*(isocarboxazid).
• have or had an eating disorder such as anorexia nervosa or bulimia.
• are allergic to the active ingredient in WELLBUTRIN SR, bupropion, or to any of the inactive ingredients. See the end of this leaflet for a complete list of ingredients in WELLBUTRIN SR.

What should I tell my doctor before using WELLBUTRIN SR?
Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.”
• Tell your doctor about your other medical conditions including if you:
• are pregnant or plan to become pregnant. It is not known if WELLBUTRIN SR can harm your unborn baby.
• are breastfeeding. WELLBUTRIN SR passes through your milk. It is not known if WELLBUTRIN SRcan harm your baby.
• have liver problems, especially cirrhosis of the liver.
• have kidney problems.
• have an eating disorder such as anorexia nervosa or bulimia.
• have had a head injury.
• have had a seizure (convulsion, fit).
• have a tumor in your nervous system (brain or spine).
• have had a heart attack, heart problems, or high blood pressure.
• are a diabetic taking insulin or other medicines to control your blood sugar.
• drink a lot of alcohol.
• abuse prescription medicines or street drugs.
• Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are using WELLBUTRIN SR.

How should I take WELLBUTRIN SR?
• Take WELLBUTRIN SR exactly as prescribed by your doctor.
• Do not chew, cut, or crush WELLBUTRIN SR Tablets. You must swallow the tablets whole. Tell your doctor if you cannot swallow medicine tablets.
• Take WELLBUTRIN SR at the same time each day.
• Take your doses of WELLBUTRIN SR at least 8 hours apart.
• You may take WELLBUTRIN SR with or without food.
• If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time. This is very important. Too much WELLBUTRIN SR can increase your chance of having a seizure.
• If you take too much WELLBUTRIN SR, or overdose, call your local emergency room or poison control center right away.
• Do not take any other medicines while using WELLBUTRIN SR unless your doctor has told you it is okay.
• It may take several weeks for you to feel that WELLBUTRIN SR is working. Once you feel better, it is important to keep taking WELLBUTRIN SR exactly as directed by your doctor. Call your doctor if you do not feel WELLBUTRIN SR is working for you.
• Do not change your dose or stop taking WELLBUTRIN SR without talking with your doctor first.

What should I avoid while taking WELLBUTRIN SR?
• Do not drink a lot of alcohol while taking WELLBUTRIN SR. If you usually drink a lot of alcohol, talk with your doctor before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
• Do not drive a car or use heavy machinery until you know how WELLBUTRIN SR affects you. WELLBUTRIN SR can impair your ability to perform these tasks.

What are possible side effects of WELLBUTRIN SR?
WELLBUTRIN SR can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects.
The most common side effects of WELLBUTRIN SR are loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often.
If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime.
These are not all the side effects of WELLBUTRIN SR. For a complete list, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store WELLBUTRIN SR?
• Store WELLBUTRIN SR at room temperature. Store out of direct sunlight. Keep WELLBUTRIN SR in its tightly closed bottle.
• WELLBUTRIN SR tablets may have an odor.

【药品名称】盐酸安非他酮缓释片
【成份】盐酸安非他酮
【性状】本品为薄膜衣片，除去包衣后显类白色。
【药理毒理】安非他酮是去甲肾上腺素、 5-羟色胺、多巴胺再摄取的弱抑制剂，对单胺氧化酶没有抑制作用。本品抗抑郁作用机制尚不清楚，可能与其抑制去甲肾上腺素和/或多巴胺的作用有关。
【适应症】（1）精神型抑郁症，特别是对用其它抗抑郁药治疗无效或不能耐受的抑郁病人。（2）用于戒烟的辅助治疗。
【用法和用量】（1）对于精神型抑郁症 口服。成人推荐剂量是一次0.15g（1片），一日两次，给药间隔应至少为8小时。该药的起始剂量是一日0.15g（1片），早餐后服用。如果0.15g的耐受性良好，最早可在第4天增加剂量到一日0.3g（2片）。
（2）对于戒烟 口服。用药开始第 1 ～ 3 天为一次 150mg （一片），每日 1 次，连续使用 3 天，随后第 4 ～ 7 天改为一次 150 mg （一片），每日 2 次。两次用药间隔时间大于 8 小时，第 8 天开始为一次 150 mg （一片），每日 1 次或 2 次。疗程 7-12 周或更长，可同时使用尼古丁代用品。本品的最大推荐剂量为一日 300mg （ 2 片），分两次服用。由于连续服药 1 周安非他酮的血药浓度才能达到稳态，所以应该在患者仍然吸烟时就开始给药。在服药的第二周设定一个目标戒烟日（通常是服药第 8 天）。若治疗 7 周后仍不见效则停止使用，停药时无需逐渐减量。在用药期间和停药后对患者进行戒烟的指导和帮助是非常必要的。
【不良反应】常见的不良反应有：激动、口干、失眠、头痛或偏头痛，恶心、呕吐，便秘、震颤、多汗、耳鸣、焦虑。
【禁忌症】
1、癫痫患者忌用；
2、单胺氧化酶（MAOI）抑制剂不能与本品同服，服用本品前至少14天不能使用单胺氧化酶抑制剂；
3、神经性食欲旺盛和厌食患者忌用；
4、本品与ZYBAN及其它含有安非他酮的药物（如ZybanTM）均不能合用；
5、对本品过敏者禁用。
【注意事项】
1、应该在医生指导下服用盐酸安非他酮，且不要超过医生所规定的疗程和随意增加安非他酮的剂量；
2、当开始治疗时期剂量要增加到每日150mg以上时，应划分成两个等剂量以减小癫痫的危险。在用剂量范围100mg-300mg/天治疗时，癫痫发生率大约为0.1%。较低的癫痫发生率是否与不同的配方或较低的剂量尚不明确。在使用本品时应考虑病人的临床状态和同时服用的药物。头部创伤史、以前的癫痫史、中枢神经系统肿瘤和同时服用降低癫痫阈值的药物可能增加癫痫的发生。过量应用乙醇、突然戒断醇或其它镇静剂；对鸦片、可卡因或刺激剂成瘾；应用超剂量刺激剂和anorectices；以及用口服降血糖药物或胰岛素治疗糖尿病等临床状态都可能引起癫痫风险增加；
3、在确信本品对病人执行那些需要判断或需要运动和识别技巧的任务时没有负面影响，否则他们不应该驾驶汽车或操作复杂的带有危险性的机器；
4、服用本品有轻微的肝细胞损伤，本品和它的代谢产物通过肾脏几乎完全排泄，幷且代谢物在尿排泄之前很可能在肝脏中发生结合，使得体内累计可能比正常人高。因此治疗肾脏或肝脏损伤的病人应该以较小的剂量开始；
5、为保证盐酸安非他酮缓释片的释放速率不会改变，应整片吞服。决不要咀嚼，划分或捣碎片剂；
6、本品中含有与用于帮助戒烟治疗的Zyban中相同的活性组分，因此本品不应与Zyban或任何其它含有bupropion的药物组成复方使用；
7、饮酒和停止饮酒都可能改变癫痫阈值，因此酒精的消耗应该减少到最小，如果可能，应该完全避免；
8、抑郁患者的自杀倾向是固有的，除非症状改善，所以处方必需是最小剂量的而且患者要在严密的控制之下；
9、年龄和性别对本品没有影响；
10、使用本品可能会改变患者的食欲或体重，需要考虑。
【药物相互作用】安非他酮可以减少药物代谢酶，改变合用药物的血药浓度。促进性药物如酰胺咪嗪、苯巴比妥、环磷酰胺，抑制性药物如甲青咪胍可影响安非他酮的药物活性。体外试验表明，安非他酮先被细胞色素P450ⅡB6同功酶代谢为吗琳代谢物，所以影响细胞色素P450的药物会影响安非他酮缓释片（如邻甲基苯海拉明和环磷酰胺），氨基苏醇代谢物不是由细胞色素P450系统生成的。动物研究表明，MAO抑制剂如苯乙肼可以提高安非他酮的急性毒性。少数临床资料表明，安非他酮和左氟多巴合用对患者有不利影响，合用时要小心，剂量增加要缓慢。能够降低癫痫发作阈值的药物和治疗因素在使用安非他酮时要非常慎重，使用较低的首剂量，剂量增加要缓慢。
【药物过量】怀疑服用过量后，如果患者是清醒的，则用吐根糖浆诱导呕吐，服用后12小时内每隔6小时服用一次活性碳，要检测基础指针、心电图，并且48小时心电监护，多喝水。如果病人昏迷、痉挛，则推荐使用胃肠插管灌洗，虽然临床过量服用速释性安非他酮后使用灌胃处理的病例很少，安非他酮缓释片没有，但在服用后12小时内药物还未完全吸收，采用此法认为是可行的。基于动物试验，推荐使用适当的苯二氮卓类药物和其它适当的方法治疗癫痫。

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详细处方信息以本药内容附件PDF文件（2009121222234012.pdf）的“原文Priscribing Information”为准
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