ZYBAN (bupropion hydrochloride) Sustained Release Tablets

Your doctor has prescribed ZYBAN as part of a program to help you quit smoking. Please read this information before you start taking ZYBAN. Also, read this section of the website 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. Be sure to discuss any questions you may have with your doctor. Remember, this medication is for you alone. Only a doctor can prescribe it for you. Never give it to someone else, because they could have serious side effects from it.

 

The active ingredient in ZYBAN is bupropion, a drug also used to treat depression. Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.

New or Worsened Emotional or Behavioural Problems

Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm, or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation.

 

IMPORTANT WARNINGS ABOUT THE RISK OF SEIZURES FOR PATIENTS TAKING ZYBAN. ZYBAN tablets should NOT be used if you are taking the antidepressant WELLBUTRIN XL, WELLBUTRIN SR or any other medications containing bupropion hydrochloride, because this will increase the likelihood of you experiencing a seizure. 

 

There is a chance that approximately 1 out of every 1,000 people taking bupropion, the active ingredient in ZYBAN, will have a seizure. The chance increases if you:

·        Have a seizure disorder (for example, epilepsy) or a history of seizures

·        Have or have had an eating disorder; for example, anorexia nervosa or bulimia (binge eating).

·        Take more than the recommended dose of ZYBAN

·        Take other medications that may increase your chance of a seizure, including drugs for depression and some antibiotics

·        Have liver problems

·        Have had serious head injury

·        Take other medicines with the same active ingredient that is in ZYBAN, such as WELLBUTRIN SR or WELLBUTRIN XL tablets (used to treat depression)

·        Use over-the-counter diet aids

·        Have diabetes which is treated with insulin or other medications

It is best not to 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. Be sure to discuss your use of alcohol with your doctor before you begin taking ZYBAN. 

You can reduce the chance of experiencing a seizure by following your doctor’s directions as to how to take ZYBAN.

 

If You Experience a Seizure:

If you experience a seizure while taking ZYBAN, contact your doctor or go to a hospital emergency ward immediately. Stop taking ZYBAN, and do not restart the medication at any later time, as you may suffer more seizures. In addition, you should not take any other medications that contain bupropion, such as the antidepressants WELLBUTRIN XL and WELLBUTRIN SR, due to the risk of more seizures.

 

Drinking Alcohol:

It is best not to drink alcohol at all while taking ZYBAN . You may be more sensitive to the effects of alcohol while taking ZYBAN. In addition, reports of other serious side effects with this combination have been received. Be sure to discuss your use of alcohol with your doctor before you begin taking ZYBAN. See also information about alcohol and seizures (Important Warning about the Risk of Seizures) and alcohol and allergic reactions (Side Effects to Watch For).

 

What  is ZYBAN?

·        ZYBAN is an oral prescription medication, to help motivated people quit smoking. 

·        ZYBAN helps to reduce withdrawal symptoms and the urge to smoke. 

·        ZYBAN should be used with a support program recommended by your health care professional, such as behavioural modification or counseling.

·        ZYBAN does not contain nicotine, unlike nicotine patches or nicotine gum. 

·        Studies have shown that more than one third of people quit smoking for at least 1 month, and more than one in five people quit smoking for at least one year while taking ZYBAN and participating in a support program.

 

Is ZYBAN right for everyone?

Only your doctor can decide if ZYBAN is right for you. You should not take ZYBAN if any of the following applies to you:

·        have a seizure disorder (for example, epilepsy);

·        previously had a seizure while taking ZYBAN or the antidepressants WELLBUTRIN SR or WELLBUTRIN XL;

·        are taking WELLBUTRIN SR or WELLBUTRIN XL tablets, or any other medicines that contain bupropion hydrochloride;

·        have or have had an eating disorder, for example bulimia (binge eating) or anorexia;

·        you have been drinking a lot of alcohol or taking benzodiazepine drugs (such as lorazepam, alprazolam, etc), and then stop abruptly;

·        are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI);

·        are allergic to bupropion.

 

How do I take ZYBAN?

Take ZYBAN as directed by your doctor. 

 

Usual recommended dosing:

·        Day 1-3: one 150 mg tablet every morning

·        Day 4 through end of treatment: one 150 mg tablet twice a day (one in the morning, and one in the early evening)

·        Be sure to take your doses at least 8 hours apart
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 taken ZYBAN for 1 week.  You should set a date to stop smoking during the second week you are taking ZYBAN.  Never take an "extra" dose of ZYBAN.  Never increase the dose of ZYBAN you, or those in your care if you are a caregiver or guardian, are taking unless your doctor tells you to. If you miss a dose of ZYBAN, do not double the next dose.  Wait and take your next tablet at the regular time.   Taking more medication than your doctor prescribed may increase the chance of having a seizure.  ZYBAN is usually prescribed for 7-12 weeks.  You may need to take ZYBAN for a longer period of time to prevent you from returning to previous smoking behaviour.  Your doctor will tell you how long you should take it according to your individual needs. 

·        Take ZYBAN with or without food. 

·        Be sure to swallow ZYBAN tablets whole.  Do not crush, cut or chew the tablets as doing so may increase the chance of side effects.

 

Is ZYBAN addictive?  

ZYBAN does not contain nicotine. When told by their doctors that it is time to stop taking ZYBAN, patients have simply been able to stop.

 

What are the possible side effects of ZYBAN and how can I manage them?

Medications affect different people in different ways. The most common side effects of ZYBAN are dry mouth and difficulty sleeping. These side effects that may occur are usually mild and temporary. 

·        If your mouth is dry, try sucking on sugarless candy or ice chips, or chewing sugarless gum.

·        If you have trouble sleeping, take your medication a few hours earlier in the evening. Remember to take your morning dose and evening dose at least 8 hours apart.

·        The most common side effects that caused people to stop taking ZYBAN during clinical trials were shakiness and skin rash. 

·        If you have signs of an allergic reaction such as a skin rash, or difficulty in breathing, stop taking ZYBAN and immediately contact your doctor or health care professional.  Some skin rashes, particularly when associated with a sore mouth and/or sore eyes may be serious, and can result in hospitalisation.  Rash with fever, joint pain or muscle pain may also be symptoms of an allergic reaction.  An anti-allergy treatment may need to be administered. The allergic reaction may persist for a while even after ZYBAN has been discontinued. Alcohol may trigger or worsen the allergic reactions, so do not consume alcohol while you are taking ZYBAN.

·       Very rarely, cases of hallucinations have been reported in association with the use of ZYBAN.  It is extremely unlikely that you will experience this side effect, but if you do, tell your doctor immediately.  You should also discuss any other troublesome side effects with your doctor. 

·        Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, consult your doctor immediately.

·        It is advised that you find out if ZYBAN affects your ability to drive a car or operate complicated or hazardous machinery before you attempt to do so. 

 

Will ZYBAN affect other medicines I am taking?

ZYBAN may affect other medicines you are taking.  While you are taking ZYBAN, it is important not to take other medicines that may increase the chance for you to have a seizure, because the combination with ZYBAN will further increase the seizure risk.  Therefore, you should make sure that your doctor knows about all medicines both prescription and over the counter that you are taking or plan to take. 

 

Are there special concerns for women?
ZYBAN 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 ZYBAN. Post-marketing reports indicate that some newborns whose mother took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressant, such as ZYBAN , during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

If you are pregnant and taking an SSRI, or other newer anti-depressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting with your doctor.

Are there any concerns for patients with liver or kidney disease?
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. 

Can ZYBAN be used at the same time as nicotine patches?
ZYBAN does not contain nicotine, therefore, 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.  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. 

Can I smoke while taking ZYBAN?

Because ZYBAN doesn’t contain nicotine, smoking while taking ZYBAN does not put you at risk of getting too much nicotine. However, your goal should be to give up cigarettes completely. Continuing to smoke after the date you set to stop smoking will seriously reduce your chance of breaking your smoking habit. 

 

When should I stop smoking?

You should set a date to stop smoking during the second week you're taking ZYBAN. 

 

Do ZYBAN Tablets have a characteristic odour?

ZYBAN tablets may have a characteristic odour. If present, this odour is normal. 

 

How should I store ZYBAN? 

Store ZYBAN at room temperature (15°C to 25°C), out of direct sunlight. Keep ZYBAN in a tightly closed container. Keep ZYBAN out of the reach of children. 
 
What is in ZYBAN?

ZYBAN contains 150 mg of bupropion hydrochloride. The tablets also contain carnauba wax, cysteine hydrochloride, hydroxylpropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, FD&C Blue No. 2 Lake, FD&C Red No. 40 Lake, polysorbate 80, and are printed with edible black ink.

 

Who markets ZYBAN?  
Biovail Pharmaceuticals Canada
7150 Mississauga Road
Mississauga, Ontario
L5N 8M5

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.

By deciding, with the help of your doctor, to take ZYBAN, you have taken the first step to becoming a non-smoker. Congratulations! It is one of the best things you can do for your health.  To make the most of your commitment to quit smoking, we encourage you to access ZYBAN^®Net at www.ZybanNet.com or by calling (800) 489-8424. Good Luck!

ZYBAN (bupropion hydrochloride) is a registered trademark of GlaxoSmithKline Group of Companies and is used under license by Biovail Pharmaceuticals Canada. ™ The appearance, namely the colour, shape and size, of the ZYBAN tablet is a trademark, used under license by Biovail Pharmaceuticals Canada. WELLBUTRIN SR (bupropion hydrochloride) is a registered trademark of GlaxoSmithKline Group of Companies and is used under license by Biovail Pharmaceuticals Canada. WELLBUTRIN XL (bupropion hydrochloride) is a registered trademark of GlaxoSmithKline Group of Companies and is used under license by Biovail Pharmaceuticals Canada.

Last Revised: November 14, 2008

Product information on this page is intended for residents of Canada only. Residents of the U.S. should return to the User Profile Selection page and select accordingly.