Bupropion HCl SR: Uses, Side Effects and Dosage

Serious warnings and precautions box

New or worsened emotional or behavioural problems:

• When you first start taking BUPROPION HCL SR or when your dose is adjusted, you may feel worse instead of better. This can include new or worsened feelings of agitation, hostility, anxiety, or impulsivity.
• It is important that you and your healthcare professional talk regularly during your treatment about how you are feeling.

• You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:

  • think your depression is getting worse, or
  • are worried about changes in your behaviour.
• If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away. Do not stop taking your medicine as it takes time for BUPROPION HCL SR to work.

Self-harm or suicide

• Antidepressants, such as BUPROPION HCL SR, can increase the risk of suicidal thoughts or actions.
• If you have thoughts of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. You will be closely monitored by a healthcare professional in this situation.

What BUPROPION HCL SR is used for:

BUPROPION HCL SR is used in adults to relieve the symptoms of:

• Depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)

How BUPROPION HCL SR Works:

BUPROPION HCL SR belongs to a group of medicines called antidepressants. BUPROPION HCL SR is thought to block reuptake of chemicals in the brain called noradrenaline and dopamine. This helps to relieve your symptoms of depression.

The ingredients in BUPROPION HCL SR are:

Medicinal ingredient: Bupropion Hydrochloride.

Non-medicinal ingredients: Carnauba Wax, Cysteine Hydrochloride, Edible Black Ink, FD&C Blue No. 2 Lake, FD&C Red No. 40 Lake, Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide.

BUPROPION HCL SR comes in the following dosage forms:

Sustained-release tablets: 150 mg.

Do not use BUPROPION HCL SR if:

• you are allergic to bupropion or any of the other ingredients in BUPROPION HCL SR tablets.
• you are taking any other medicines which contain bupropion hydrochloride, such as WELLBUTRIN XL, ZYBAN^® and CONTRAVE^®.
• you have been diagnosed with epilepsy or have a history of seizures or fits.
• you previously had seizures while taking the antidepressants WELLBUTRIN^® XL, the smoking cessation medication ZYBAN® or the weight-loss medication CONTRAVE®.

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

  • bulimia (binge eating and throwing up 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 monoamine oxidase inhibitor (MAOI) antidepressants, such as phenelzine, moclobemide, and tranylcypromine.
• 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 BUPROPION HCL SR. 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, ZYBAN^® 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 BUPROPION HCL SR.
  • 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 BUPROPION HCL SR may cause your speech disorder to come back or worsen.

Other warnings you should know about:

BUPROPION HCL SR can cause serious side effects, including:

• Seizures (fits): Your risk of seizures increases when you take BUPROPION HCL SR, especially:

  • if your dose of BUPROPION HCL SR increases;
  • if you do not take BUPROPION HCL SR as prescribed;
  • if you take certain medicines at the same time;
  • if you are already at higher than usual risk of seizures.
• Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): BUPROPION HCL SR can cause an acute attack of glaucoma. Having your eyes examined before you take BUPROPION
• HCL SR 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.
• Liver disorders: This includes hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes).
• Hallucinations, delusions, paranoia (sensing or believing things that are not there).
• Mania: Antidepressants, such as BUPROPION HCL SR, may trigger manic episodes in patients with bipolar disorder during the depressed state of their illness or psychosis in other susceptible patients.
• Hypertension (high blood pressure): Your healthcare professional may monitor your blood pressure, especially if you are using nicotine patches while you are taking BUPROPION HCL SR.
• Hyponatremia (low sodium in the blood).

• Serotonin toxicity (also known as serotonin syndrome): BUPROPION HCL SR 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 BUPROPION HCL SR with certain anti-depressants or migraine medications.

  Serotonin toxicity symptoms include:

  • fever, sweating, shivering, diarrhea, nausea, vomiting
  • muscles shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination, flushing
  • fast heartbeat, changes in blood pressure
  • confusion, agitation, restlessness, hallucinations, mood changes unconsciousness, anxiety and coma
• Severe allergic reactions:
• BUPROPION HCL SR 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 BUPROPION HCL SR, your symptoms may not go away even after you stop taking it.
• Severe skin reactions: Taking BUPROPION HCL SR may cause serious skin reactions. These include 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 BUPROPION HCL SR and contact your healthcare professional immediately if you experience these symptoms.

• Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): BUPROPION HCL SR 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.
• Brugada syndrome (serious heart problem): BUPROPION HCL SR 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 BUPROPION HCL SR.

Before you start taking BUPROPION HCL SR, 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 for more information on these and other serious side effects.

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

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

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

Driving and using machines:

• BUPROPION HCL SR may impair your ability to do tasks requiring judgement, thinking or motor skills.
• You should not drive or use machines until you know how BUPROPION HCL SR affects you.

Pregnancy:

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

• If you have been prescribed BUPROPION HCL SR 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 BUPROPION HCL SR. It is very important that you do not stop taking BUPROPION HCL SR without first consulting with your healthcare professional.

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

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

Serious drug interactions:

Serious drug interactions with BUPROPION HCL SR include:

• medicines that contain bupropion hydrochloride (e.g., WELLBUTRIN XL, ZYBAN^® and CONTRAVE^®)
• monoamine oxidase inhibitors (MAOI) taken within the last 14 days, which are used to treat depression (e.g., phenelzine, moclobemide, and tranylcypromine)
• medicines that contain thioridazine taken within the last 14 days, which are typically used to treat schizophrenia and psychosis

Do not take BUPROPION HCL SR if you are taking any of these medicines. Ask your healthcare professional if you are unsure

The following may also interact with BUPROPION HCL SR:

• Medicines used to treat depression and other mental illnesses, such as citalopram, paroxetine, venlafaxine, nortriptyline, imipramine, desipramine, fluoxetine, sertraline, phenelzine, 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 medicines 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 BUPROPION HCL SR:

• BUPROPION HCL SR sustained-release tablets should not be confused with other bupropion formulations.

• To minimize your risk of seizures:

  • Take BUPROPION HCL SR exactly as directed by your healthcare professional. If you have any problems with your dosing routine, contact your healthcare professional.
  • Never take more than 150 mg of BUPROPION HCL SR at one time.
  • Never increase the dose of BUPROPION HCL SR unless your healthcare professional tells you to.
  • If you are prescribed 300 mg a day, take your BUPROPION HCL SR doses at least 8 hours apart, at about the same times each day. If you have trouble sleeping while taking BUPROPION HCL SR, take the second tablet earlier in the evening (but at least 8 hours after the first tablet).
  • BUPROPION HCL SR tablets must be taken orally. Swallow your BUPROPION HCL SR tablets whole, with water. Do not crush, cut or chew tablets.
  • BUPROPION HCL SR can be taken with or without food.

  • The effects of your medicine may not be noticeable in the first few days of treatment and improvement may take several weeks. If you are concerned that your medicine is not working:

    • continue taking your medicine as it takes time for BUPROPION HCL SR to work, and
    • discuss this with your healthcare professional.
  • You should talk to your healthcare professional before you stop taking your medication on your own. You may experience unwanted side effects if you suddenly stop taking BUPROPION HCL SR.

Usual dose:

• The usual adult dose is one 150 mg tablet once daily.
• Your dose may be increased to one 150 mg tablet twice daily (i.e. 300 mg per day) after 1 week. Be sure to take your doses at least 8 hours apart.

Overdose:

The symptoms of an overdose include:

• Drowsiness
• Fainting
• Respiratory arrest (breathing stops)
• Amnesia (loss of memories)
• Seizures
• Irregular heartbeat, which may be life-threatening.

• Serotonin syndrome, which is a serious condition and may be life-threatening (see the

  Serious side effects and what to do about them table for more details).

If you think you, or a person you are caring for, have taken too much BUPROPION HCL SR contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you forget or miss a dose of BUPROPION HCL SR, 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 BUPROPION HCL SR:

These are not all the possible side effects you may have when taking BUPROPION HCL SR. If you experience any side effects not listed here, tell your healthcare professional.

The side effects of BUPROPION HCL SR may include:

• Very common side effects (may affect more than 1 in 10 people)

  • constipation,
  • dry mouth,
  • headache,
  • insomnia (a sleeping disorder that makes it hard to fall asleep),
  • nausea,
  • dizziness,

• Common side effects (may affect up to 1 in 10 people)

  • abnormal dreams,
  • acne,
  • blocked or stuffy nose,
  • decreased weight,
  • feeling jittery,
  • flatulence,
  • hot flush,
  • memory loss,
  • muscle spasms,
  • painful periods or menstrual cramps,
  • panic attack,
  • ringing in ears,
  • shakiness,
  • taste is altered,
  • thirsty,
  • tremor,

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store BUPROPION HCL SR at room temperature (15ºC to 25ºC).
• Keep container tightly closed.
• If your healthcare professional tells you to stop taking BUPROPION HCL SR, please return any leftover medicine to your pharmacist.
• Keep out of reach and sight of children.

If you want more information about BUPROPION HCL SR:

• 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) or by calling 1-800-361-4261.

Date of Authorization: 2025-11-25