PATIENT INFORMATION

See the patient leaflet at the end of this monograph.

Patients should be made aware that Zyban, used as an aid to smoking cessation, contains the same active ingredient found in Wellbutrin and Wellbutrin SR used to treat depression and that Zyban should not be used in conjunction with Wellbutrin, Wellbutrin SR, or any other medications that contain bupropion HCl.

Physicians Are Advised to Discuss the Following Issues with Patients Treated for Depression

As dose is increased during initial titration to doses above 150 mg/day, patients should be instructed to take bupropion sustained release tablets in two divided doses, preferably with at least eight hours between successive doses, to minimize the risk of seizures. Patients should be told that any CNS-active drug like bupropion HCl may impair their ability to perform tasks requiring judgement or motor and cognitive skills. Consequently, until they are reasonably certain that bupropion HCl does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Patients should be told that the use and the cessation of use of alcohol may alter seizure threshold, and, therefore, that the consumption of alcohol should be minimized, and if possible, avoided completely. Patients should be advised to inform their physicians if they are taking or plan to take any prescription or over-the-counter drugs. Concern is warranted because bupropion HCl and other drugs may affect each other's metabolism. Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy. Patients should be advised to wswallow bupropion HCl sustained release tablets whole so that the release rate is not altered. Do not chew, divide, or crush tablets.

Information for Patients Using Bupropion Sustained Release Tablets as an Aid to Smoking Cessation: See patient information leaflet at the end of this monograph. Physicians are advised to review the leaflet with their patients.

PATIENT PACKAGE INSERT

For Bupropion HCl Sustained Release Tablets Only: Please read this information before you start taking bupropion sustained release tablets for depression or smoking cessation. Also read this leaflet each time you renew your prescription, in case anything has changed. This information is not intended to take the place of discussions between you and your doctor. You and your doctor should discuss bupropion HCl as it related to the treatment of your depression or as party of your plan to stop smoking. Do not let anyone else use your bupropion.

IMPORTANT WARNING: At a dose of 300 mg each day, there is a chance that approximately 1 out of every 1000 people taking bupropion HCl, the active ingredient in bupropion sustained release tablets, will have a seizure. The chance of this happening increases if you

Have a seizure disorder (for example, epilepsy). Have or have had an eating disorder (for example, bulimia or anorexia nervosa). Take more than the recommended amount of bupropion sustained release tablets. Take other medications with the same active ingredient that is in bupropion HCl (such as taking Wellbutrin (bupropion HCl for depression) and taking Zyban (bupropion HCl for smoking cessation).

You can reduce the chance of experiencing a seizure by following your doctor's directions on how to take bupropion HCl. You should also discuss with your doctor whether bupropion HCl is right for you.

What Is Bupropion HCl? Bupropion HCl is a prescription medicine to treat depression. It is also used to help people quit smoking. Studies have wshow that more than one third of people quit smoking for at least 1 month while taking bupropion HCl and participating in a patient support program. For many patients, bupropion reduces withdrawal symptoms and the urge to smoke. Bupropion HCl should be used with a patient support program. It is important to participate in the behavioral program, counseling, or other support program your health care professional recommens.

Who Should Not Take Bupropion? You should not take bupropion if you

Have a seizure disorder (for example, epilepsy). Are already taking any other medications that contain bupropion HCl such as Wellbutrin, Wellbutrin SR, or Zyban. Have or have had an eating disorder (for example, bulimia or anorexia nervosa). Are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI). Are allergic to bupropion.

Are There Special Concerns for Women? Bupropion is not recommended for women who are pregnant or breast-feeding. Women should notify their doctor if they become pregnant or intend to become pregnant while taking bupropion HCl.
How Should I Take Bupropion?

You should take bupropion as directed by your doctor.
The usual recommended dosing is to take one 150-mg tablet in the morning for the first 3 days. As early as the fourth day of treatment, your doctor may increase your dose to one 150-mg tablet in the morning and one 150-mg tablet in the early evening. Doses should be taken at least 8 hours apart.
For Depression: If your depression does not improve after several weeks, your doctor may increase the dose of bupropion HCl to a total of 400 mg each day (taken as 200 mg in the morning and 200 mg in the early evening).
Never take an "extra" dose of bupropion HCl for any reason, even if you miss a dose. If you forget to take a dose, do not take an extra tablet to "catch up" for the dose you forgot. Wait and take you next tablet at the regular time. Do not take more tablets than your doctor prescribed. This is important so you do not increase your chance of having a seizure.
It is important to wswallow bupropion HCl sustained release tablets whole. Do not chew, divide, or crush tablets.
How Long Should I Take Bupropion? For depression, only you and your doctor can determine how long you should take bupropion HCl. You and your doctor should discuss your signs and symptoms of depression regularly to determine how long you should take bupropion HCl. Do not stop taking your medicine or decrease the amount of medicine you are taking without talking to your doctor first. For smoking cessation, most people should take bupropion for 7 to 12 weeks. Follow your doctors instructions.
What Are Possible Side Effects of Bupropion? Like all medications, bupropion may cause side effects

The most common side effects of bupropion HCl in clinical studies are: include dry mouth and difficulty sleeping. At 300 mg/day: Loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, and shakiness. At 400 mg/day:Abdominal (stomach) pain, agitation, anxiety, dizziness, dry mouth, difficultysleeping,clepain,nausea, rapid heart beat, sore throat, sweating, ringing in the ars,andurinatingmore often. The most common side effects that caused people to stop taking bupropion HCl during clinical studies were shakiness, skin rash, nausea, agitation, and migraine (a severe type of headache). The side effects of bupropion HCl are generally mild and often disappear after a few weeks. If you have nausea, you may want to take your medicine with food. If you have difficulty sleeping, avoid taking your medication too close to bedtime. Contact your doctor or health care professional if you have signs of an allergic reaction such as a rash, hives or difficulty in breathing. Discuss any other troublesome side effects with your doctor. Use caution before driving a car or operating complex, hazardous machinery until you know if bupropion affects your ability to perform these tasks.

Will Taking Bupropion HCl Change My Body Weight? In clinical studies with bupropion HCl, some people lost weight and other people gained weight.

For people who lost weight, 14 out of 100 people taking 300 mg/day of bupropion HCl lost more than 5 lbs, 19 out of 100 people taking 400 mg/day lost more than 5 lbs, and 6 out of 100 people taking placebo (a sugar pill) lost more than 5 lbs.

For people who gained weight, 3 out of 100 people taking 300 mg/day of bupropion HCl gained more than 5 lbs, 2 out of 100 people taking 400 mg/day gained more than 5 lbs, and 4 out of 100 people taking placebo (a sugar pill) gained more than 5 lbs.

Since weight change (gain or loss) also can be a symptom of depression, you should discuss with your doctor whether bupropion HCl is right for you.Can I Drink Alcohol While I Am Taking Bupropion? It is best not to drink alcohol at all or to drink very little while

taking bupropion HCl. If you usually drink a lot of alcohol, or if you drink a lot and suddenly stop, you may increase your chance of having a seizure. Therefore, it is important to discuss your use of alcohol with your doctor before you begin taking bupropion HCl.

Will Bupropion Affect Other Medications I Am Taking? Bupropion HCl may affect other medications you're taking. It is important not to take medications that may increase the chance for you to have a seizure. Therefore, you should make sure that your doctor knows about all medicines¾prescription or over-the-counter¾you are taking or plan to take.

Do Bupropion Tablets Have a Characteristic Odor? Bupropion tablets may have a characteristic odor. If present, this odor is normal.

How Should I Store Bupropion

Store bupropion HCl at room temperature, out of direct sunlight. Keep bupropion HCl in a tightly closed container. Keep bupropion HCl out of the reach of children.

Additional Information for Smoking Cessation

When Should I Stop Smoking? It takes about 1 week for bupropion to reach the right levels in your body to be effective. So, to maximize your chance of quitting, you should not stop smoking until you have been taking bupropion HCl for 1 week. You should set a date to stop smoking during the second week you're taking bupropion HCl.

Can I Smoke While Taking Bupropion? It is not physically dangerous to smoke and use bupropion HCl at the same time. However, continuing to smoke after the date you set to stop smoking will seriously reduce you chance of breaking your smoking habit.

Can Bupropion Be Used at the Same Time as Nicotine Patches? Yes, bupropion HCl and nicotine patches can be used at the same time but should only be used together under the supervision of your doctor. Using bupropion HCl and nicotine patches together may raise your blood pressure. Your doctor will probably want to check your blood pressure regularly to make sure that it stays within acceptable levels.

DO NOT SMOKE AT ANY TIME if you are using a nicotine patch or any other nicotine product along with bupropion HCl. It is possible to get too much nicotine and have serious side effects.

This summary provides important information about bupropion. This summary cannot replace the more detailed information that you need from your doctor. If you have any questions or concerns about either bupropion, depression or smoking cessation, talk to your doctor or other health care professional.