Bupropion Hydrochloride (bue-PROE-pee-on hye-droe-KLOR-ide), Naltrexone Hydrochloride (nal-TREX-one hye-droe-KLOR-ide)

Used with diet and exercise to help you lose weight.

Brand Name(s):

Contrave

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• It is best to take this medicine with food or milk. However, do not take this medicine with high-fat meals. This may increase your risk of seizures.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not take an extra dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine and an MAO inhibitor (MAOI) within 14 days of each other. Do not take this medicine if you are using or have used heroin or other opioid drugs (including buprenorphine, codeine, methadone, or other habit-forming painkillers) within the past 7 to 10 days. Do not use naltrexone/bupropion if you are also using Zyban® to quit smoking or Aplenzin® or Wellbutrin® for depression, because they also contain bupropion.
• Tell your doctor if you take barbiturates, benzodiazepines, antiseizure medicine, or sedatives, or if you have recently stopped taking them.
• Some medicines can affect how naltrexone/bupropion works. Tell your doctor if you are using any of the following:
  • Amantadine, amiloride, cimetidine, clopidogrel, digoxin, dopamine, famotidine, levodopa, memantine, metformin, metoprolol, oxaliplatin, pindolol, ranitidine, theophylline, ticlopidine, varenicline
  • Insulin or diabetes medicine
  • Medicine to treat depression (including SSRIs, TCAs)
  • Medicine to treat mental illness (including haloperidol, risperidone, thioridazine)
  • Medicine to treat heart rhythm problems (including flecainide, procainamide, propafenone)
  • Medicine to treat HIV or AIDS (including efavirenz, lopinavir, ritonavir)
  • Medicine for pain, diarrhea, cough, or colds
  • Steroid medicine
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed while you are using this medicine, unless your doctor says it is okay.
• Tell your doctor if you have kidney disease, liver disease, diabetes, glaucoma, heart disease, mental problems (including bipolar disorder), or high blood pressure. Tell your doctor if you have a history of head injury, infection, seizures, stroke, eating disorder, or drug or alcohol use.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  • Increased risk of seizures
  • High blood pressure or heart rate
  • Serious skin reactions (including Stevens-Johnson syndrome)
  • Liver problems, including hepatitis
  • Changes in mood or behavior
  • Increased risk of hypoglycemia (low blood sugar) in patients with diabetes
• You have a higher risk of accidental poisoning, serious injury, or death if you use heroin or any other opioid medicine while you are being treated with this medicine. Also, naltrexone prevents you from feeling the effects of heroin if you use it.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Chest pain, trouble breathing, fast, slow, or pounding heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Eye pain, vision changes, seeing halos around lights
• Muscle or joint pain, fever with rash
• Seeing or hearing things that are not there, feeling like people are against you
• Seizures
• Sudden increase in energy, racing thoughts, trouble sleeping
• Thoughts of hurting yourself, worsening depression, severe agitation or confusion

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Dry mouth
• Headache, dizziness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088