Zyban: Uses, Side Effects and Dosage

Serious warnings and precautions box

What ZYBAN is used for:

ZYBAN is used in motivated adults to help quit smoking when combined with:

• a support program such as counselling; or
• a nicotine replacement therapy (e.g., patches, gum, lozenges, etc.).

A nicotine replacement therapy alone should be considered before trying ZYBAN.

How ZYBAN works:

It is not known exactly how ZYBAN works. It is thought to increase chemicals in the brain called noradrenaline and dopamine. This may help reduce withdrawal symptoms and the urge to smoke.

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

The ingredients in ZYBAN are:

Medicinal ingredient: bupropion hydrochloride.

Non-medicinal ingredients: Carnauba Wax, Cysteine Hydrochloride, FD&C Blue No. 2 Lake, FD&C Red No. 40 Lake, Hydroxypropyl-Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide. Tablets are printed with edible black ink.

ZYBAN comes in the following dosage forms:

Tablets; 150 mg of bupropion hydrochloride.

Do not use ZYBAN if:

• you know that you are allergic to bupropion or any of the other ingredients of ZYBAN.
• you are taking any other medicines which contain bupropion hydrochloride, such as WELLBUTRIN XL, WELLBUTRIN SR, or CONTRAVE®.
• you have been diagnosed with a seizure disorder (for example epilepsy) or have a history of seizures or fits.
• you previously had seizures while taking ZYBAN or the antidepressants WELLBUTRIN^® SR or WELLBUTRIN^® XL.

• you have, or have had, an eating disorder, such as:

  • bulimia (binge eating and then purging so you don’t gain weight);
  • anorexia (eating very little).
• you are a heavy drinker, have recently stopped drinking alcohol, and have withdrawal symptoms.
• you have suddenly stopped taking benzodiazepines or other sedatives (medicines used to treat anxiety and sleep disorders) and have withdrawal symptoms.
• you are taking or have recently taken in the last 14 days medications called monoamine oxidase inhibitors (MAOIs), for depression (such as phenelzine, moclobemide, and tranylcypromine) or for Parkinson’s disease (such as selegiline).
• you are taking or have recently taken in the last 14 days thioridazine (an antipsychotic medicine that is typically used to treat schizophrenia and psychosis).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZYBAN. Talk about any health conditions or problems you may have, including if you:

• are at a higher risk of seizures. This includes if you:

  • are taking other medicines containing bupropion, such as WELLBUTRIN XL, WELLBUTRIN SR, and CONTRAVE^®.
  • have ever had any fits or seizures in the past.
  • have had a serious head injury.
  • have or have had a tumour in your brain or spinal cord.
  • have liver problems.
  • are addicted to opioids, cocaine or other drugs that stimulate your central nervous system.
  • excessively drink alcohol. It is best not to drink alcohol at all. If you drink a lot of alcohol and suddenly stop, you may increase your risk of having a seizure. Be sure to discuss your use of alcohol with your healthcare professional before you start taking ZYBAN.
  • have diabetes and take insulin or other medicines to control your blood sugar.

  • take other medications that may increase your risk of having a seizure, such as:

    • medicines used to treat depression or other mental disorders (e.g., serotonergic agents);
    • medicines used to treat psychotic symptoms;
    • medicines used to treat malaria;
    • lithium, a medicine used to treat bipolar disorder;
    • amantadine, a medicine used to treat Parkinson’s Disease;
    • theophylline, a medicine used to treat asthma and other lung diseases;
    • steroids, which are medicines used to treat inflammation;
    • some antibiotics (e.g., quinolones);
    • over-the-counter stimulants (e.g., diphenhydramine, dextromethorphan, or pseudoephedrine); or
    • diet aids.
• have bipolar disorder.
• are using nicotine patches to help you stop smoking.
• have recently had a heart attack or have heart disease.
• are taking tamoxifen, a medicine used to treat breast cancer.
• are 65 years of age or older.
• are taking medicines that are known to lower the level of sodium in your blood (e.g., thiazide diuretics, a type of “water pill”).
• have kidney problems.
• have or have had a speech disorder where you stammer or stutter (dysphemia). Taking ZYBAN may cause your speech disorder to come back or worsen.

Other warnings you should know about:

ZYBAN can cause serious side effects including:

• Seizures (fits): Your risk of seizures increases when you take ZYBAN, even if you have never had one before. Factors that increase your risk of seizures while taking ZYBAN:

  • when your dose of ZYBAN increases;
  • if you do not take ZYBAN as prescribed;
  • if you take certain medicines at the same time;
  • if you are already at higher than usual risk of seizures.

• Serotonin toxicity (also known as serotonin syndrome): ZYBAN can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take ZYBAN with certain anti-depressants or migraine medications.

  Serotonin toxicity symptoms include:

  • fever, sweating, shivering, diarrhea, nausea, vomiting;
  • muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
  • fast heartbeat, changes in blood pressure;
  • confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

• Severe allergic reactions:

  • ZYBAN XL may cause an allergic reaction. Symptoms may include skin rash, hives, swelling of the face or throat, muscle pain, joint pain, difficulty breathing, severe skin reactions, chest pain, or fever.
  • If you have an allergic reaction while taking ZYBAN XL, your symptoms may not go away even after you stop taking it.

• Severe skin reactions: Taking ZYBAN may cause serious skin reactions. This includes Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening, and erythema multiforme. The following symptoms may be related to these skin reactions:

  • Early warnings for patients:

    • fever
    • severe skin rash
    • swelling, swollen lymph glands
    • flu-like feeling
    • itching
    • body aches
    • blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body

  • Later developments:

    • yellow skin or eyes
    • shortness of breath
    • dry cough
    • chest pain or discomfort
    • feeling thirsty
    • urinating less often, less urine

Stop taking ZYBAN and contact your healthcare professional immediately if you experience these symptoms.

• Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): ZYBAN has been associated with new or worsening symptoms in patients susceptible to SLE and CLE. These are autoimmune diseases where your body’s immune system attacks your own tissues and organs. Talk to your healthcare professional right away if you have blotchy rashes mainly on the face, fatigue, joint pain, swelling in the joints, muscle pain, rash, swelling, fever, nausea, or loss of appetite.

• Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): ZYBAN can cause an acute attack of glaucoma. Having your eyes examined before you take ZYBAN could help identify if you are at risk of having angle-closure glaucoma. Get immediate medical help if you experience:

  • eye pain;
  • changes in vision;
  • swelling or redness in or around the eye.

• Brugada syndrome (serious heart problem): ZYBAN may reveal a hidden heart problem you did not know you had, a problem called Brugada syndrome. Brugada syndrome can be serious and cause sudden death. Get immediate medical help if you experience fainting, dizziness, heart palpitations or abnormal heartbeat while taking ZYBAN.

  Before you start taking ZYBAN, tell your healthcare professional if you:

  • have Brugada syndrome.
  • have unexplained fainting, or a family history of Brugada syndrome or unexplained sudden death before 45 years of age. This could mean you may have Brugada syndrome.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Alcohol: ZYBAN lowers your alcohol tolerance. This means you may feel the effects of alcohol when taking less alcohol than usual. Drinking alcohol while taking ZYBAN may increase your risk of having seizures and allergic reactions. It is best not to drink alcohol at all while taking ZYBAN to avoid side effects.

Misuse: ZYBAN is intended for oral use only. Taking ZYBAN by any other route may lead to seizure, overdose or even death.

Pregnancy:

• If you are pregnant, your healthcare professional will determine if ZYBAN is right for you. They will also discuss the risks of birth defects and complications after birth if you take ZYBAN during pregnancy.

• If you have been prescribed ZYBAN during pregnancy, be ready to seek immediate medical help for your newborn if they:

  • have trouble breathing or feeding;
  • have muscle stiffness, or floppy muscles (like a rag doll);
  • have seizures (fits);
  • are shaking (jitteriness);
  • are constantly crying.
• Tell your healthcare professional right away if you become pregnant while taking ZYBAN. It is very important that you do not stop taking ZYBAN without first consulting with your healthcare professional.

Breastfeeding: ZYBAN passes into breastmilk and could harm a breastfed baby. You and your healthcare professional will decide if you should take ZYBAN or breastfeed. You should not do both.

Urine drug screening test: If you take a urine drug screening test, ZYBAN may give a positive test result for amphetamines. Tell the laboratory technician that you are taking ZYBAN. They can do a more specific drug screening test for you.

Driving or using machines: ZYBAN may impair your ability to do tasks requiring judgement, thinking, or motor skills. You should not drive or use machines until you know how ZYBAN affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions:

The following may also interact with ZYBAN:

• medicines used to treat depression and other mental illnesses, such as citalopram, paroxetine, venlafaxine, nortriptyline, imipramine, desipramine, fluoxetine, sertraline, haloperidol, or risperidone.
• medicines used to treat Parkinson’s Disease, such as levodopa, amantadine, or orphenadrine.
• medicines used to prevent epilepsy or seizures, such as carbamazepine, phenytoin, or phenobarbital.
• medicines used to treat cancer, such as cyclophosphamide or ifosfamide.
• medicines used to treat HIV infection, such as ritonavir, lopinavir, or efavirenz.
• beta blockers, which are used to lower your blood pressure. This includes metoprolol, bisoprolol, or carvedilol.
• medicines used to regulate your heart rhythm, such as propafenone, or flecainide.
• medicines used to reduce blood clots, such as ticlopidine or clopidogrel.
• nicotine patches, which are used to help you stop smoking.
• tamoxifen, a medicine used to treat breast cancer.
• digoxin, a medicine used to treat various heart conditions.
• theophylline, a medicine used to treat asthma and other lung diseases.
• lithium, a medicine used to treat bipolar disorder.
• steroids, which are used to treat inflammation, such as prednisone.
• alcoholic beverages.

How to take ZYBAN:

• Never take an “extra” dose of ZYBAN.
• Never take more than one tablet at a time, or more than 2 tablets in one day.
• ZYBAN can be taken with or without food.
• Swallow ZYBAN tablets whole. Do not crush, cut or chew the tablets.
• If you have trouble sleeping while taking ZYBAN, take the second tablet earlier in the evening (but at least 8 hours after the first tablet).
• ZYBAN tablets may have a distinctive odour; this is normal.
• It takes about 1 week for ZYBAN to reach the right levels in your body to be effective. Therefore, to maximize your chance of quitting, you should not stop smoking until you have taken ZYBAN for 1 week. Your target date to stop smoking should be during the second week of taking ZYBAN.

Using ZYBAN at the same time as nicotine patches:

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, sometimes severely. Tell your healthcare professional if you are planning to use nicotine replacement therapy so that your blood pressure can be checked regularly.

Smoking while taking ZYBAN:

It is not dangerous to smoke while taking ZYBAN. If you continue to smoke after the date you set to quit while taking ZYBAN this will lower your chances of success in breaking your smoking habit.

Usual dose:

Your healthcare professional will determine the right dose for you. The usual adult dose is listed in this table:

ZYBAN is usually taken for 7 to 12 weeks. You may need to take ZYBAN for a longer period of time to prevent you from returning to your previous smoking behaviour. You and your healthcare professional will decide how long you should take ZYBAN according to your individual needs.

Overdose:

The symptoms of an overdose include:

• drowsiness;
• fainting;
• respiratory arrest (breathing stops);
• amnesia (loss of memories);
• seizures;
• irregular heartbeat, which can be life-threatening;
• serotonin syndrome, which is a serious condition that can be life-threatening. See the Serious side effects and what to do about them table for more details.

Missed Dose:

If you forget or miss a dose of ZYBAN skip the missed dose and take the next dose as scheduled. Do not double the dose to make up for the missed dose.

Possible side effects from using ZYBAN:

These are not all the possible side effects you may have when taking ZYBAN. If you experience a side effect not listed here, tell your healthcare professional.

Side effects may include:

• difficulty sleeping,
• dry mouth,
• stuffy or runny nose,
• dizziness,
• nausea,
• constipation,
• trouble concentrating,
• feeling anxious,
• joint aches.

Even if you do not take medicine to help you quit smoking you might feel depressed, short-tempered, frustrated, angry, nervous and impatient while trying to quit. Your appetite might also increase, and you may gain weight.

Serious side effects and what to do about them:

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store ZYBAN at 15^oC - 25^oC. Store in a dry place, protected from light.

Keep out of reach and sight of children.

If you want more information about ZYBAN:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschhealth.ca, or by calling 1-800-361-4261.

Bausch Health, Canada Inc.

2150 St. Elzear Blvd., West,

Laval, QC, H7L 4A8

www.bauschhealth.ca

Date of Authorization: 2025-05-16