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Wellbutrin Patient, Information, Instructions - Bupropion

Wellbutrin Patient, Information, Instructions - Bupropion

Information for the Patient
ZYBAN^® (bupropion hydrochloride) Sustained-Release Tablets

Please read this information before you start taking ZYBAN. 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 ZYBAN as part of your plan to stop smoking. Your doctor has prescribed ZYBAN for your use only. Do not let anyone else use your ZYBAN.

IMPORTANT WARNING:

There is a chance that approximately 1 out of every 1,000 people taking bupropion hydrochloride, the active ingredient in ZYBAN, will have a seizure

The chance of this happening increases if you:

• have or have had a seizure disorder (for example, epilepsy);
• have or have had an eating disorder (for example, bulimia or anorexia nervosa);
• are abruptly discontinuing use of alcohol or sedatives (including benzodiazepines);
• take more than the recommended amount of ZYBAN; or
• take other medicines with the same active ingredient that is in ZYBAN, such as WELLBUTRIN^® (bupropion hydrochloride) Tablets, WELLBUTRIN SR^® (bupropion hydrochloride) Sustained-Release Tablets, and WELLBUTRIN XL (bupropion hydrochloride extended-release tablets). (These medicines are used to treat depression.)

You can reduce the chance of experiencing a seizure by following your doctor.s directions on how to take ZYBAN. If you experience a seizure while taking ZYBAN, stop taking the tablets immediately, contact your doctor, and do not restart ZYBAN. In addition, tell your doctor if you have or have had other medical conditions. You should also discuss with your doctor whether ZYBAN is right for you.

Important information I should know and share with my family about taking antidepressants.

Although ZYBAN is not a treatment for depression, it contains the same active ingredient as WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL that are used for depression. Therefore, you should be aware of the following information. Patients taking antidepressants, and their families, should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your doctor.

1. What is ZYBAN?
ZYBAN is a prescription medicine to help people quit smoking. Studies have shown that more than one third of people quit smoking for at least 1 month while taking ZYBAN and participating in a patient support program. For many patients, ZYBAN reduces withdrawal symptoms and the urge to smoke. ZYBAN 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 recommends.

2. Who should not take ZYBAN?
You should not take ZYBAN if you:

• have or have had a seizure disorder (for example, epilepsy);
• are already taking WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, or any other medicines that contain bupropion hydrochloride;
• have or have had an eating disorder (for example, bulimia or anorexia nervosa);
• are abruptly discontinuing use of alcohol or sedatives (including benzodiazepines);
• are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI); or
• are allergic to bupropion.

3. Can I take ZYBAN if I have mild-to-moderate chronic bronchitis and/or emphysema (also called chronic obstructive pulmonary disease or COPD)?
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 your health care professional recommends.

4. Are there special concerns for women? ZYBAN is not recommended for women who are pregnant or breastfeeding. Women should notify their doctor if they become pregnant or intend to become pregnant while taking ZYBAN.

5. Are there any concerns for patients with liver or kidney problems?
If you have liver or kidney problems, tell your doctor before taking ZYBAN. Depending on the severity of your condition, your doctor may need to adjust your dosage.

6. How should I take ZYBAN?

• You should take ZYBAN as directed by your doctor. The usual recommended dosing 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 your doctor 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.

7. How long should I take ZYBAN?
Most people should take ZYBAN for at least 7 to 12 weeks. Some people may need to take ZYBAN for a longer period of time to assist in their smoking cessation efforts. Follow your doctor.s instructions.

8. 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.

9. Can I smoke while taking ZYBAN?
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 your smoking habit.

10. Can ZYBAN be used at the same time as nicotine patches?
Yes, ZYBAN and nicotine patches can be used at the same time but should only be used together under the supervision of your doctor. Using ZYBAN and nicotine patches together may raise your blood pressure, sometimes severely. Tell your doctor if you are planning to use nicotine replacement therapy because 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 ZYBAN. It is possible to get too much nicotine and have serious side effects.

11. What are possible side effects of ZYBAN?
Like all medicines, ZYBAN may cause side effects. Do not rely on this summary alone for information about side effects. Your doctor can discuss with you a more complete list of side effects that may be relevant to you.

• Hypertension (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, see Question #10).
• The most common side effects include dry mouth and difficulty sleeping. These side effects are generally mild and often disappear after a few weeks. If you have difficulty sleeping, avoid taking your medicine too close to bedtime.
• The most common side effects that caused people to stop taking ZYBAN during clinical studies were shakiness and skin rash.
• Stop taking ZYBAN and contact your doctor or health care professional if you have signs of an allergic reaction such as a rash, hives, or difficulty in breathing. It is not possible to predict whether a mild rash will develop into a more serious reaction. Therefore, if you experience a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, or swelling of lips or tongue, tell a doctor immediately, since these symptoms may be the first signs of a serious reaction. Discuss any other troublesome side effects with your doctor.
• Use caution before driving a car or operating complex, hazardous machinery until you know if ZYBAN affects your ability to perform these tasks.

12. Can I drink alcohol while I am taking ZYBAN?
It is best to not drink alcohol at all or to drink very little while taking ZYBAN. If you drink a lot of alcohol and suddenly stop, you may increase your chance of having a seizure. Some people have reported lower alcohol tolerance during treatment with ZYBAN. Therefore, it is important to discuss your use of alcohol with your doctor before you begin taking ZYBAN.

13. Will ZYBAN affect other medicines I am taking?
ZYBAN may affect other medicines you.re taking. It is important not to take medicines that may increase the chance for you to have a seizure. Therefore, you should make sure that your doctor knows about all medicines.prescription or over-the-counter.you are taking or plan to take.

14. Do ZYBAN Tablets have a characteristic odor?
ZYBAN Tablets may have a characteristic odor. If present, this odor is normal.

15. How should I store ZYBAN?

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

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

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