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BUNAVAIL- buprenorphine and naloxone film

  1. Patient Information
  2. What Is Bunavail?
  3. Who Should Not Take Bunavail?
  4. Bunavail May Not Be Right For You. Before Taking Bunavail, Tell Your Doctor If You:
  5. Bunavail Can Cause Serious Side Effects Including:
  6. How Should I Dispose Of Unused Bunavail?
  7. Active Ingredients:
  8. Inactive Ingredients:
  9. Manufactured For:

Patient Information 

Advise patients to read the FDA-approved patient labeling (Medication Guide).

Safe Use

Before initiating treatment with BUNAVAIL, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time BUNAVAIL is dispensed because new information may be available.

  • BUNAVAIL must be administered whole. Advise patients not to chew or swallow BUNAVAIL.
  • Inform patients and caregivers that potentially fatal additive effects may occur if BUNAVAIL is used with benzodiazepines or other CNS depressants, including alcohol. Counsel patients that such medications should not be used concomitantly unless supervised by a healthcare provider[

    • BUNAVAIL can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if:
      • You feel faint, dizzy or confused
      • Your breathing gets much slower than is normal for you.

      These can be signs of an overdose or other serious problems.

    • Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine that may be different than other buprenorphine containing medicines you may have been taking.
    • BUNAVAIL contains an opioid that can cause physical dependence.
      • Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
      • Physical dependence is not the same as drug addiction.
      • BUNAVAIL is not for occasional or "as needed" use.
    • An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using BUNAVAIL. Ask your doctor what you should do if you are taking one of these.
    • Call a doctor or get emergency help right away if you:
      • Feel sleepy and uncoordinated
      • Have blurred vision
      • Have slurred speech
      • Cannot think well or clearly
      • Have slowed reflexes and breathing
    • Do not inject ("shoot-up") BUNAVAIL.
      • Injecting BUNAVAIL may cause life-threatening infections and other serious health problems.
      • Injecting BUNAVAIL may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
    • In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with BUNAVAIL.

What Is Bunavail? 

  • BUNAVAIL is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal), as part of a complete treatment program that also includes counseling and behavioral therapy.
BUNAVAIL is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your BUNAVAIL in a safe place to protect it from theft. Never give your BUNAVAIL to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.
  • It is not known if BUNAVAIL is safe or effective in children.

Who Should Not Take Bunavail? 

Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone.

Bunavail May Not Be Right For You. Before Taking Bunavail, Tell Your Doctor If You: 

  • Have trouble breathing or lung problems
  • Have an enlarged prostate gland (men)
  • Have a head injury or brain problem
  • Have problems urinating
  • Have a curve in your spine that affects your breathing
  • Have liver or kidney problems
  • Have gallbladder problems
  • Have adrenal gland problems
  • Have Addison's disease
  • Have low thyroid (hypothyroidism)
  • Have a history of alcoholism
  • Have mental problems such as hallucinations (

    • Always take BUNAVAIL exactly as your doctor tells you. Your doctor may change your dose after

      • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you.Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take BUNAVAIL.
      • You should not drink alcoholwhile using BUNAVAIL, as this can lead to loss of consciousness or even death.

Bunavail Can Cause Serious Side Effects Including: 

    • Store BUNAVAIL at room temperature between 68 F to 77 F (20 C to 25 C).
    • Keep BUNAVAIL dry.
    • Do not freeze BUNAVAIL.
    • Do not use BUNAVAIL buccal film if the foil package has been damaged.
    • Keep BUNAVAIL in a safe place, out of sight and reach of children.

How Should I Dispose Of Unused Bunavail? 

  • Dispose of unused BUNAVAIL buccal film as soon as you no longer need them.
  • Remove the unused BUNAVAIL buccal film from the foil packages.
  • Drop the BUNAVAIL buccal films into the toilet and flush.
  • Do not flush the BUNAVAIL foil packages or cartons down the toilet. If you need help with disposal of BUNAVAIL, call 1-800-469-0261.

General information about the safe and effective use of BUNAVAIL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BUNAVAIL for a condition for which it was not prescribed. Do not give BUNAVAIL to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about BUNAVAIL. If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for health professionals.

For more information, call 1-800-469-0261.

Active Ingredients: 

buprenorphine hydrochloride, naloxone hydrochloride dihydrate

Inactive Ingredients: 

carboxymethylcellulose sodium, citric acid, citrus blend flavor, dibasic sodium phosphate, blue ink, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, polycarbophil, propylene glycol, propylparaben, yellow iron oxide, sodium benzoate, sodium hydroxide, sodium saccharin, vitamin E acetate, and purified water. The blue ink contains FD&C blue #1, ethanol, purified shellac, acetone, ammonium hydroxide and water.

Manufactured For: 

BioDelivery Sciences International, Inc., Raleigh, North Carolina 27612 USA


Issued: February 2018

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