To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Safety Information for Patients Taking Zyban (Bupropion) URL: http://www.pslgroup.com/dg/206EA2.htm Doctor's Guide September 24, 2001
MISSISSAUGA, ON -- September 24, 2001 -- GlaxoSmithKline, following discussions with Health Canada, would like to inform consumers about important safety information for Zyban® (bupropion hydrochloride), a medication used to help people stop smoking and available in Canada since August 1998 for this indication, and also sold as Wellbutrin SR for treatment of depression. Wellbutrin SR has been available in Canada since May of 1998. The important safety information below applies to those patients who are taking bupropion.
Zyban is generally well tolerated. However, as with any medication, adverse reactions are possible when taking Zyban. The most common side effects are dry mouth and difficulty sleeping. These effects are usually mild and temporary. Other side effects that have commonly been reported include nausea, constipation, headache, shakiness and altered taste. You may also experience some side effects while taking Zyban, which are also effects associated with stopping smoking. These include having difficulty concentrating, becoming dizzy, confused, anxious, fidgety, irritable, depressed, or rarely, you may have a very marked mood change.
High blood pressure, in some cases severe, has been reported in patients taking Zyban alone and in combination with nicotine replacement therapy (for example, a nicotine patch), used to help patients stop smoking. Tell your doctor if you are using, or plan to use, nicotine replacement therapy. Infrequently, you may experience chest pain, possibly heart related, an increase in heart rate or, rarely, you may faint during treatment with Zyban.
There is a chance that approximately one out of 1000 patients taking Zyban may have a seizure. This risk may increase with some medical conditions or if you are taking certain medications, so it is important to inform your doctor of all the medications you are taking and any medical conditions you may have. Be certain to also discuss your use of alcohol with your doctor prior to using Zyban.
In order to reduce the risk of a seizure, you should not take Zyban if:
- You are currently taking Wellbutrin SR tablets, used to treat depression
- You have a seizure disorder, such as epilepsy
- You have, or ever had, an eating disorder, such as anorexia nervosa or binge eating (bulimia)
- You have been drinking a lot of alcohol or taking benzodiazepine drugs (such as lorazepam, alprazolam, etc.), and then stop abruptly.
Other medical conditions that may increase your risk for seizure include: history of seizures, serious head injury, diabetes that is treated with insulin or other medications, and some liver problems. You can reduce the chance of experiencing a seizure by following your doctor's directions as to how to take Zyban.
You should not take more than 150 mg (one pill) at a time. When you are taking two daily doses of 150 mg each (two pills per day), doses should be taken at least eight hours apart. If you experience a seizure while taking Zyban, go to a doctor or hospital immediately, and do not take any more of the drug.
You should also not take Zyban if you have taken a monoamine oxidase (MAO) inhibitor or thioridazine (Mellaril) within the past 14 days, or if you are allergic to any of the ingredients in Zyban tablets. It is important to be aware of the signs and symptoms of an allergic reaction, which may include skin rash, difficulty breathing, itching, hives, chest pain, and swelling of the mouth or face. If you experience these symptoms, stop taking Zyban immediately and contact your doctor.
Zyban may affect other medicines you are taking. Sometimes the dose of another medicine may need to be adjusted when Zyban is started. You should make sure your doctor knows about all prescription and over-the-counter medicines you are taking or plan to take while taking Zyban.
Other side effects are also possible with Zyban. If you are concerned about any adverse reaction when taking Zyban or Wellbutrin SR, please contact your doctor.
GlaxoSmithKline has recently provided physicians with a similar update about safety information to help ensure that physicians are prescribing the medication optimally.
SOURCE: GlaxoSmithKline Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.