Contrave: Uses, Side Effects and Dosage

Serious Warnings and Precautions

New or worsened emotional or behavioural problems:

• Bupropion, one of the ingredients in CONTRAVE, is also used to treat depression. When you first start taking CONTRAVE or when your dose is adjusted, you may experience new or worsened feelings of depression, 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 taking this medicine to help you manage your weight. Ask them to read this leaflet. You might ask them to tell you if they are worried about changes in your behaviour.
• If you experience changes in your behaviour, tell your healthcare professional right away.

Self-harm or Suicide:

• Bupropion, one of the ingredients in CONTRAVE, 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 is CONTRAVE used for?

CONTRAVE is used in adults together with a reduced-calorie diet and increased physical activity to manage weight in adults who are:

• obese; or

• overweight and who have at least one weight-related problem, such as:

  • high blood pressure that is controlled by medicine,
  • type 2 diabetes, or
  • high levels of lipids in the blood (e.g., cholesterol or other types of fat).

It is not known if it is safe to take CONTRAVE with other weight loss products. Other products include prescription drugs, over the counter drugs, and natural health products. It is also not known if CONTRAVE changes your risk of heart or blood vessel problems (e.g., stroke) or of death due to heart or blood vessel problems.

CONTRAVE is not for use in patients younger than 18 years of age.

How does CONTRAVE work?

CONTRAVE contains two ingredients, naltrexone hydrochloride and bupropion hydrochloride. These medicines work on two separate areas of the brain to help control eating (appetite and cravings).

What are the ingredients in CONTRAVE?

Medicinal ingredients: Naltrexone Hydrochloride and Bupropion Hydrochloride.

Non-medicinal ingredients: Colloidal Silicon Dioxide, Crospovidone, Edetate Disodium, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Lactose Monohydrate, L-Cysteine Hydrochloride, Macrogol/Peg, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol-Part Hydrolyzed, Talc, and Titanium Dioxide.

CONTRAVE comes in the following dosage forms:

Extended-release tablets: 8 mg of naltrexone hydrochloride and 90 mg of bupropion hydrochloride for each tablet. The tablets are blue, round, and have “NB-890” on one side.

Do not use CONTRAVE if:

• you are allergic to naltrexone, bupropion, or any of the other ingredients in CONTRAVE.
• you have high blood pressure that cannot be controlled by medicine.
• you have severe liver problems.
• you have end-stage kidney failure (kidney failure where the kidneys do not work enough to support the needs of your body).
• you have or had seizures.
• you are taking thioridazine, an antipsychotic medicine that is typically used to treat schizophrenia and psychosis. An ingredient in CONTRAVE may cause the level of thioridazine in your blood to increase.
• you are taking any other medicines which contain bupropion hydrochloride, such as WELLBUTRIN^® SR, WELLBUTRIN^® XL and ZYBAN^®.

• you have or had an eating disorder such as:

  • anorexia (eating very little),
  • bulimia (eating too much and throwing up so you don’t gain weight).
• you are dependent on opioid pain medicines or use medicines to help stop taking opioids (e.g., methadone or buprenorphine), or are in opioid withdrawal.
• you drink a lot of alcohol and abruptly stop drinking.
• you take medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them all of a sudden.

• you are taking medicines called monoamine oxidase inhibitors (MAOIs).

  • Ask your healthcare professional if you are not sure if you take an MAOI.
  • Do not start CONTRAVE until you have stopped taking your MAOI for at least 14 days.
• you are pregnant or planning to become pregnant. Tell your healthcare professional right away if you become pregnant while taking CONTRAVE.

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

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

  • have had a serious head injury.
  • have ever had any fits or seizures in the past, especially if you have ever had a seizure while taking CONTRAVE, WELLBUTRIN^® SR, WELLBUTRIN^® XL, or ZYBAN^®;
  • have or have had a tumour or infection in your brain or spinal cord;
  • have had a stroke (bleeding or blood clot in the brain);
  • have blood vessel problems;
  • have low sodium or low sugar levels in your blood;
  • have low oxygen levels in your body;
  • have liver problems;
  • are addicted to cocaine or other drugs that stimulate your central nervous system;
  • excessively take sedatives or have withdrawal symptoms from discontinuing sedatives;
  • excessively drink alcohol;
  • have diabetes and take insulin or other medicines to control your blood sugar (e.g., sulfonylureas and meglitinides);
  • are taking medications that lower the seizure threshold (e.g., medicines used to treat depression and other mental health problems, theophylline, and systemic steroids).
• have or had depression or other mental health problems.
• have bipolar disorder or are at a higher risk for bipolar disorder (e.g., family history of bipolar disorder, suicidal thoughts or actions, or depression).
• have suicidal thoughts or actions or have attempted suicide in the past.
• have or had liver problems.
• have high blood pressure that is controlled by medicine or have a higher risk of developing high blood pressure.
• have or had a heart attack.
• have kidney problems.
• are over 65 years of age.

• are lactose intolerant or have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in CONTRAVE.

• are dependent on alcohol or being treated for alcohol dependence.
• have significant weight loss.
• have systemic lupus erythematosus (SLE), an autoimmune disease where your body’s immune system attacks your own tissues and organs.
• have anatomically narrow angles (the space or angle between the cornea and iris is abnormally small).
• have or have had a speech disorder where you stammer or stutter (dysphemia). Taking CONTRAVE may cause your speech disorder to come back or worsen.

Other warnings you should know about:

CONTRAVE can cause the following serious side effects:

• Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): One of the ingredients in CONTRAVE, bupropion, can cause an acute attack of glaucoma. Having your eyes checked before you take CONTRAVE 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
• Blood pressure and heart rate increases: You may be more at risk if you already have high blood pressure.

• Brugada syndrome (serious heart problem): Bupropion, one of the ingredients in CONTRAVE, 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 CONTRAVE.

  Before you start taking CONTRAVE, 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.
• Hallucinations, delusions, paranoia (seeing, sensing or believing things that are not there).
• Hypoglycemia (low blood sugar): You may be more at risk of developing hypoglycemia if you have type 2 diabetes, and you lose weight while taking CONTRAVE. This applies only if you take medicines to treat type 2 diabetes such as insulin or sulphonylureas. You may need a change in your medicine used to treat your diabetes.
• Liver problems: This includes hepatitis (inflammation of the liver) and liver dysfunction.

• Seizures (fits): The risk of having a seizure while taking CONTRAVE is related to the dose. It is important that you take CONTRAVE exactly as your healthcare professional tells you to. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and get immediate medical help.

  Your risk of seizures increases if you take CONTRAVE, especially:

  • if your dose of CONTRAVE increases;
  • if you do not take CONTRAVE as directed;
  • if you take CONTRAVE with high-fat meals;
  • if you take certain medicines at the same time;
  • if you are already at a higher than usual risk of seizures.

• Serotonin toxicity (also known as serotonin syndrome): CONTRAVE 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. It is more likely to develop serotonin toxicity when you start taking CONTRAVE or when your dose is increased. It may also occur if you take CONTRAVE with certain antidepressants or migraine medications.

  Serotonin toxicity symptoms include:

  • fever, sweating, shivering, diarrhea, nausea, vomiting;
  • muscle 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 reaction:

  • CONTRAVE 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 your symptoms may not go away even after you stop taking CONTRAVE.

• Severe skin reactions: Taking CONTRAVE may cause serious skin reactions. This included Stevens-Johnson Syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), and erythema multiforme. Stop taking CONTRAVE and get immediate medical help if you experience:

  • severe skin rash
  • peeling of the skin
  • blisters around the mouth, eyes or genitals
  • itching
  • chest pain
  • swelling
  • shortness of breath
  • body aches
  • fever
• Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): CONTRAVE 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.

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

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

Pregnancy and Breastfeeding:

• Do not take CONTRAVE if you are pregnant. Tell your healthcare professional right away if you become pregnant while taking CONTRAVE. They will discuss the risks of birth defects and complications after birth if you take CONTRAVE during pregnancy.
• Talk to your healthcare professional if you are breastfeeding or thinking of breastfeeding. CONTRAVE passes into breastmilk. You should not breastfeed while you are taking CONTRAVE.

Opioid overdose: If you take opioids while taking CONTRAVE, the ingredient naltrexone in CONTRAVE can increase your chance of having an opioid overdose. Examples of opioids or medicines that contain opioids include heroin, prescription pain medicines, and methadone.

You can accidentally overdose in two ways:

• Naltrexone blocks the effects of opioids. Because of this, do not take large amounts of opioids to try to overcome the opioid-blocking effects of naltrexone. It can lead to serious injury, coma, or death.

• After you take naltrexone, its blocking effect slowly decreases and goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with CONTRAVE can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:

  • after you have gone through detoxification
  • when your next dose of CONTRAVE is due
  • if you miss a dose of CONTRAVE
  • after you stop CONTRAVE treatment

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

Opioid withdrawal: You should not use any type of opioid for at least 7 to 10 days before starting CONTRAVE. This includes street drugs, prescription pain medicines (including tramadol), cough, cold, diarrhea medicines that contain opioids, or opioid dependence treatments (e.g., buprenorphine or methadone). Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare professional if you are taking CONTRAVE before a medical procedure or surgery.

Testing and Check-Ups: Your healthcare professional may perform certain tests (e.g., blood tests) to monitor:

• your blood pressure and heart rate before and regularly during your treatment with

  • CONTRAVE, especially if you have type 2 diabetes.
• your blood sugar and red blood cell levels before and during your treatment with CONTRAVE, especially if you have type 2 diabetes.
• any emotional and behavioural changes for the first few months after you start your treatment, and when your dose changes. This can include the feelings of depression, anxiety, agitation, irritability, behavioural changes, or suicidal thoughts and behaviour.
• if your kidneys are working properly.
• if your liver is working properly.

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

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

Serious drug interactions with CONTRAVE include:

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

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

The following may interact with CONTRAVE:

• alcohol.
• cimetidine, a medicine used to treat ulcers of the stomach and intestines.
• digoxin, a medicine used to treat various heart conditions.
• lithium, a medicine used to treat bipolar disorder.
• medicines used to help you to sleep (e.g., sedatives such as diazepam).
• medicines used to lower your blood pressure (e.g., valsartan, clonidine, or beta blockers such as metoprolol).
• medicines used to prevent epilepsy or seizures (e.g., carbamazepine, phenobarbital, phenytoin, or valproate).
• medicines used to regulate your heart rhythm (e.g., propafenone or flecainide).
• medicines used to treat cancer (e.g., cyclophospamide, ifosphamide, or tamoxifen).
• medicines used to treat diabetes by helping to control sugar levels in the blood (e.g., metformin, insulin, sulphonylureas, glyburide, glibenclamide, nateglinide or repaglinide).
• medicines used to treat depression and other mental health problems (e.g., citalopram, desipramine, venlafaxine, haloperidol, risperidone, selective serotonin reuptake inhibitors [SSRIs], imipramine, or paroxetine).
• medicines used to treat hay fever, itch, swelling, and other allergic reactions (e.g., antihistamines or steroids).
• medicines used to treat heart disease or stroke (e.g., ticlopidine, digoxin, or clopidogrel).
• medicines used to treat HIV infection and AIDS (e.g., ritonavir, lopinavir, efavirenz, or orphenadrine).
• medicines used to treat infections (e.g., quinolones such as ciprofloxacin).
• medicines used to treat Parkinson’s Disease (e.g., levodopa and amantadine).
• nifedipine, a medicine used to treat chest pain or high blood pressure.

• opioids and medicines that contain opioids, used to treat:

  • cough and cold (e.g., mixtures containing dextromethorphan or codeine);
  • opiate addiction (e.g., methadone);
  • pain (e.g., morphine, codeine, or tramadol);
  • diarrhea (e.g., loperamide).
• theophylline, a medicine used to treat asthma and other lung diseases.

How to take CONTRAVE:

• CONTRAVE must be taken with a reduced calorie-diet and increased physical activity.
• Take CONTRAVE exactly as your healthcare professional tells you to.
• Do not change your CONTRAVE dose without talking with your healthcare professional They will change your dose if needed. Your risk of seizures may increase if you take more CONTRAVE than your healthcare professional tells you to.
• If you have not lost a certain amount of weight after 16 weeks of treatment, your healthcare professional may tell you to stop taking CONTRAVE.
• CONTRAVE must be taken orally by mouth. Swallow CONTRAVE tablets whole. Do not cut, chew, or crush the tablets. Tell your healthcare professional if you cannot swallow CONTRAVE tablets whole.
• Take each dose of CONTRAVE with food. Do not take CONTRAVE with high-fat meals as it may increase your risk of seizures.
• Do not drink a lot of alcohol while taking CONTRAVE. Talk with your healthcare professional if you drink a lot of alcohol. If you suddenly stop drinking alcohol, you may increase your chance of having a seizure.

Usual dose:

Your healthcare professional will determine the right dose for you based on your health, your condition, and how you react to CONTRAVE. Your dose may be increased by your healthcare professional based on a weekly schedule. Never take more than you are prescribed per day.

The table below explains how the usual adult dose of CONTRAVE will be slowly increased over the first 4 weeks:

The maximum dose for CONTRAVE should not be exceed:

• Do not take more than 2 tablets at the same time; and
• Do not take more than 4 tablets in one day (e.g., 2 tablets in the morning and 2 tablets in the evening).

Overdose:

If you take too many CONTRAVE tablets, you may increase your risk of having serious and life-threatening effects, including:

• seizures,
• hallucinations (seeing or believing thing that are not there),
• loss of consciousness or coma,
• irregular heartbeat,
• fever,
• muscle rigidity or muscle breakdown,
• low blood pressure,
• stupor,
• difficulty breathing,
• heart problems,
• serotonin toxicity (also known as 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.

If you think you, or a person you are caring for, have taken too much CONTRAVE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of CONTRAVE, do not take the missed dose. Instead, take the next dose at the usual scheduled time. Do not double the dose to make up for the missed dose.

What are possible side effects from using CONTRAVE?

These are not all the possible side effects you may feel when taking CONTRAVE. If you experience any side effects not listed here, tell your healthcare professional.

The common side effects of CONTRAVE include:

• nausea;
• constipation;
• diarrhea;
• dizziness;
• feeling off balance or like everything is spinning (vertigo);
• dry mouth;
• headache or migraine;
• trouble sleeping;
• vomiting;
• abdominal pain;
• upset stomach;
• shaking (tremor);
• foul, salty, rancid or metallic taste in the mouth;
• sleepiness, feeling tired, lack of energy;
• trouble paying attention;
• abnormal dreams;
• flu;
• excessive sweating more than usual;
• itching;
• rash;
• hair loss;
• ringing in the ear;
• blurred vision.

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 (https://www.canada.ca/en/health‐canada/services/drugshealth‐products/medeffect‐canada/adverse‐reaction‐reporting.html) 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 CONTRAVE at room temperature between 15°C to 25°C.
• Keep container tightly closed.
• If your healthcare professional tells you to stop taking CONTRAVE, return any leftover medicine to your pharmacist.
• Keep out of reach and sight of children.

If you want more information about CONTRAVE:

• 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

Last Revised: SEP 19, 2025