Important Safety Information

What are the serious warnings and precautions about CONTRAVE®?

One of the ingredients in CONTRAVE® is bupropion. When you first start taking CONTRAVE®, 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 relatives or close friends that you are taking this medicine to help you manage your weight. 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.

If you have thoughts of harming or killing yourself or others at any time, tell your healthcare professional or go to a hospital right away. Close observation by a healthcare professional is necessary in this situation.

When should I not use CONTRAVE®?

Do not use CONTRAVE® if you are:

Do not use CONTRAVE® if you have:

Do not use CONTRAVE® if you drink a lot of alcohol and may abruptly stop drinking, or use medicines called sedatives (medicines that make you sleepy), benzodiazepines, or anti-seizure medicines and you may stop using them all of a sudden.

How can I help avoid side effects and ensure that I use CONTRAVE® properly?

CONTRAVE® can have potential side effects. Talk about any health conditions or problems you may have to your doctor before you take CONTRAVE®, including if you have:

Talk to you doctor if you are:

What other warnings should I know about?

CONTRAVE® can cause the following:

What should I know about pregnancy during CONTRAVE® treatment?

Tell your doctor right away if you become pregnant while taking CONTRAVE®. Your doctor will determine if CONTRAVE® is right for you.

What should I know about opioid overdose during CONTRAVE® treatment?

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.

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.

What should I know about opioid withdrawal during CONTRAVE® treatment?

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, or 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 doctor if you are taking CONTRAVE® before a medical procedure or surgery.

Will I need to do testing and check-ups?

Your doctor may perform certain tests (e.g., blood tests) to monitor:

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®. A more specific drug screening test can be made available for you.

Are there any drug interactions with CONTRAVE®?

Serious drug interactions with CONTRAVE® include:

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

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

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, contact your doctor.

The common side effects of CONTRAVE® include:

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

Serious side effects and what to do about them

Talk to your healthcare professional if you have any of the following side effects:

Stop taking CONTRAVE® and get immediate medical help if you have any of the following side effects:

Please consult the consumer information leaflet contained in your product package for complete details regarding possible serious side effects.

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