ZYBAN (bupropion) is a round purple film coated tablet with the engraving of “ZYBAN 150” on its surface. It is a sustained released tablet manufactured in only a single strength (150 milligrams).

AM I ADDICTED TO CIGARETTES?

You may be addicted to cigarettes if you experience one or more of the following signs:

- You continue to smoke despite the desire to quit.

- You have made a serious, but unsuccessful, attempt to stop using tobacco or permanently reduce the amount you use.

- Your attempts to stop smoking have led to physical withdrawal symptoms, including a craving for tobacco, anxiety, irritability, restlessness, difficulty concentrating, headaches, drowsiness, and stomach upset.

- You develop a "tolerance" for tobacco. Smoking the same number of cigarettes produces less effect over time, making it necessary to increase the number of cigarettes you smoke to achieve the desired sensation.

- You have continued to use tobacco even when you have a serious physical problem (such as heart or lung disease) that you know is worsened by tobacco.

WITHDRAWL:

When smokers who are addicted to cigarettes quit smoking, they may suffer from symptoms that can be psychological, emotional, or physical in nature. This is called withdrawal. They may experience irritability, anxiety, difficulty concentrating, restlessness, or depression.

HOW DOES ZYBAN WORK?

The mechanism by which ZYBAN enhances the ability of patients to abstain from smoking is not totally known. It is presumed that it inhibits specific chemical receptors in the brain that mediate the craving for smoking.

HOW EFFECTIVE IS ZYBAN?

Clinical studies have shown that ZYBAN reduces the craving for cigarettes as well as withdrawal symptoms associated with smoking cessation to a significant degree when compared with placebo. Reductions in the following withdrawal symptoms were most pronounced: irritability, frustration or anger, anxiety, difficulty concentrating, restlessness and depressed mood. In clinical studies it has been demonstrated that ZYBAN achieves the best results in diminishing the withdrawal symptoms of nicotine, significant reduction in craving for cigarettes and an elevated abstinence rate in the long term. In addition, your chances of quitting with ZYBAN greatly depend on your commitment to quitting.

CAN I DO ANYTHING TO MAKE ZYBAN MORE EFFECTIVE?

Yes, ZYBAN while effective medication may work best if you are enrolled in a smoking cessation program or behavioral support program.

HOW SHOULD I TAKE ZYBAN?

- The usual recommended dosage is to take one 150-mg tablet in the morning for the first 3 days. On the fourth day, begin taking 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.

- Never take an "extra" dose of ZYBAN. If you forget to take a dose, do not take an extra tablet to "catch up" for the dose you forgot. Wait and take your next tablet at the regular time. Do not take more tablets than prescribed. This is important so you do not increase your chance of having a seizure.

- It is important to swallow ZYBAN tablets whole. Do not chew, divide, or crush tablets. You may take ZYBAN with or without food.

HOW LONG DO I REMAIN ON ZYBAN?

For most patients, it is recommend that you stay on ZYBAN for at least 7 to 12 weeks to help support long-term success. It may be necessary to stay on ZYBAN for a longer period, depending upon the rapidity with which you withdraw from nicotine. You've probably been smoking for some time, and your body has become accustomed to it. ZYBAN helps reduce withdrawal symptoms as you remove cigarettes from your life. It's important to remain on ZYBAN for at least 7 to 12 weeks but it may require up to 6 months of therapy if your dependence on nicotine is great.

WHEN SHOULD I STOP SMOKING?

It takes about 1 week for ZYBAN 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 ZYBAN for 1 week. You should set a date to stop smoking during the second week you're taking ZYBAN.

CAN I DRINK OR SMOKE WHILE TAKING ZYBAN?

It is best not to drink alcohol at all, or to drink very little, while taking ZYBAN. People who drink a lot of alcohol and then suddenly stop drinking, may increase their risk of developing a seizure.

It is not physically dangerous to smoke and use ZYBAN at the same time. However, continuing to smoke after the date you set to stop smoking will seriously reduce your chance of breaking the smoking habit.

CAN I TAKE ZYBAN IF I HAVE MILD-TO-MODERATE CHRONIC BRONCHITIS AND/OR EMPHYSEMA?

Yes, ZYBAN combined with a behavior modification program has been shown to help people with COPD quit smoking. It is important to participate in the behavior program, counseling, or other support program that is offered in your community.

ARE THERE ANY SPECIAL CONCERS FOR WOMEN?

ZYBAN is not recommended for women who are pregnant or breast-feeding. Women should probably not begin a smoking cessation program with ZYBAN if they are breast-feeding or intend to become pregnant.

ARE THERE ANY SPECIAL CONCERS FOR PATIENTS WITH LIVER OR KIDNEY PROBLEMS?

If you have liver or kidney problems, let us know on your medical history/personal profile before taking ZYBAN. Depending on the severity of your condition, the dosage of the drug my need to be adjusted.

CAN ZYBAN BE USED AT THE SAME TIME AS NICOTENE PATCHES?

Yes, ZYBAN and nicotine patches can be used at the same time but should only be used together under the supervision of your healthcare professional. Using ZYBAN and nicotine patches together may raise your blood pressure. Your healthcare professional 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 the nicotine patch or any other nicotine product along with ZYBAN. It is possible to get too much nicotine and experience serious side effects.

CAN I SMOKE WHILE USING ZYBAN?

It is not physically dangerous to smoke and use ZYBAN at he same time. However, continuing to smoke after the date you set to stop smoking will seriously reduce your chances of breaking the smoking habit.

ZYBAN AND SLEEPING:

If you have trouble sleeping, try not to take your medication too close to bedtime. If you're taking two tablets each day, take one early in the day and the second one in the late afternoon or very early evening. Be sure that you take them at least 8 hours apart. Also, try to avoid drinking any beverages that contain caffeine in the late afternoon or evening. This includes coffee, tea, and many sodas.

ZYBAN AND SEIZURES:

There is an increased risk of developing a seizure when taking ZYBAN, although this risk is quite small. Nonetheless, it is important to let us know on your medical history/personal profile about any other prescription or over-the-counter medications that you are taking.

SIDE EFFECTS OF ZYBAN:

The most common side effects from ZYBAN are dry mouth and some difficulty sleeping. If you experience dry mouth while you're taking ZYBAN, you may be more comfortable if you drink plenty of water. Also, some people find that sucking on lozenges or chewing sugarless gum helps keep your mouth moist.

The most common side effects that caused people to stop taking ZYBAN during clinical studies were shakiness and skin rash. Stop taking ZYBAN if you have signs of an allergic reaction such as a rash, hives, or difficulty in breathing.

WHO SHOULD NOT TAKE ZYBAN:

You should not take ZYBAN if you:

- are taking WELLBUTRIN (bupropion HCl) Tablets or WELLBUTRIN SR (bupropion HCl) Sustained-Release Tablets.

- are taking any other medicines that contain bupropion HCl.

- have or have had a seizure disorder (for example, epilepsy).

- have or have had an eating disorder.

- are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI).

- are allergic to bupropion HCl.