MEDICATION GUIDE

Buprenorphine ( bue” pre nor’ feen) and Naloxone ( nal ox’ one)

Sublingual Film for sublingual or buccal administration (CIII)

IMPORTANT:

Keep buprenorphine and naloxone sublingual film in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes buprenorphine and naloxone sublingual film, get emergency help or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children. 

What is the most important information I should know aboutbuprenorphine and naloxone sublingual film?

• Buprenorphine and naloxone sublingual film contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life‐threatening breathing problems, especially if you take or use certain other medicines or drugs.
• Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of buprenorphine and naloxone sublingual film by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid.
• Buprenorphine and naloxone sublingual film may cause serious and life‐threatening breathing problems. Get emergency help right away if you:

  feel faint feel dizzy are confused feel sleepy or uncoordinated

  have blurred vision have slurred speech are breathing slower than normal cannot think well or clearly

• Do not takebuprenorphine and naloxonesublingual film with certain medicines. Takingbuprenorphine and naloxone sublingual film  with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Do not inject (“shoot‐up”)buprenorphine and naloxone.Injecting buprenorphine and naloxone may cause life‐threatening infections and other serious health problems. Injecting buprenorphine and naloxone may cause sudden serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
• Do not switch from buprenorphine and naloxone sublingual film to other medicines that contain buprenorphinewithout talking with your healthcare provider. The amount of buprenorphine in a dose of buprenorphine and naloxone sublingual film is not the same as in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of buprenorphine and naloxone sublingual film that may be different than other buprenorphine containing medicines you may have been taking.
• Do not stop taking buprenorphine and naloxone sublingual film suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine (physical dependence). Physical dependence is not the same as drug addiction.
• In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with buprenorphine and naloxone sublingual film.
• Never give anyone else your buprenorphine and naloxone sublingual film. They could die from taking it. Selling or giving away buprenorphine and naloxone sublingual film is against the law.
• Store buprenorphine and naloxone sublingual film securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

What is buprenorphine and naloxone sublingual film?

• Buprenorphine and naloxone sublingual film is a prescription medicine used to treat opioid addiction in adults and is part of a complete treatment program that also includes counseling and behavioral therapy. 
  Who should not take buprenorphine and naloxone sublingual film?
  Do not take buprenorphine and naloxone sublingual filmif you are allergic to buprenorphine or naloxone.  
  Before taking buprenorphine and naloxonesublingual film, tell your healthcare provider about all your medical conditions, including if you have:

  trouble breathing or lung problems a curve in your spine that affects your breathing Addison’s disease

  an enlarged prostate (men) problems urinating liver, kidney, or gallbladder problems alcoholism

  a head injury or brain problem mental health problems adrenal gland or thyroid gland problems tooth problems, including a history of cavities

Tell your healthcare provider if you are:

• pregnant or plan to become pregnant.If you take buprenorphine and naloxone sublingual film while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life‐threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Breastfeeding or plan to breastfeed.Buprenorphine and naloxone can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take buprenorphine and naloxone sublingual film. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with buprenorphine and naloxone sublingual film.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, or herbal supplements.  

How should I take buprenorphine and naloxone sublingual film?

Read the Instructions for Use at the end of this Medication Guide for detailed instructions on how to take buprenorphine and naloxone sublingual film.

• Take buprenorphine and naloxone sublingual film exactly as prescribed by your healthcare provider. Your healthcare provider may change your dose after seeing how it affects you. Do not change your dose unless your healthcare provider tells you to change it.
• Do not take buprenorphine and naloxone sublingual film more often than prescribed by your healthcare provider.
• Buprenorphine and naloxonesublingual film is not for occasional or “as needed” use.
• When you are beginning treatment, take buprenorphine and naloxone sublingual film only under the tongue (sublingual administration).
• After a few days, you can choose whether you will take buprenorphine and naloxone sublingual film on the inside of your cheek (buccal administration) or under the tongue (sublingual administration).
• After buprenorphine and naloxone sublingual film is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.
• Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking buprenorphine and naloxone sublingual film.
• Take the entire buprenorphine and naloxone sublingual film. Do not cut, tear, chew, or swallow buprenorphine and naloxone sublingual film because the medicine will not work as well.
• If you miss a dose of buprenorphine and naloxone sublingual film, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
• Dispose of expired, unwanted, or unused buprenorphine and naloxone sublingual film by removing buprenorphine and naloxone sublingual film from the foil packaging, and promptly flushing down the toilet (if a drug take‐back option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
• If you take too much buprenorphine and naloxonesublingual filmor overdose, call Poison Control or get emergency medical help right away.

What should I avoid while taking buprenorphine and naloxone sublingual film?

• Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how buprenorphine and naloxone sublingual film affects you. Buprenorphine can cause drowsiness and slow reaction times. Buprenorphine can cause drowsiness and slow reaction times. Buprenorphine and naloxone sublingual film can make you sleepy, dizzy, or lightheaded.
• You should not drink alcoholor take prescription or over‐the‐counter medicines that contain alcohol while taking buprenorphine and naloxone sublingual film, because this can lead to loss of consciousness or even death.

What are thepossiblesideeffectsofbuprenorphineandnaloxonesublingualfilm?

Buprenorphineandnaloxone sublingualfilmcancauseserious side effects,including:

• Trouble breathing.Taking buprenorphine and naloxone sublingual film with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants can cause breathing problems that can lead to coma and death.
• Sleepiness, dizziness, and problems with coordination.
• Physical dependency or abuse.
• Liver problems. Call your healthcare provider right away if you notice any of these symptoms:

• Your healthcare provider should do blood tests to check your liver before you start taking and while you take buprenorphine and naloxone sublingual film.
• Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, low blood pressure, or loss of consciousness. Call your healthcare provider or get emergency help right away.
• Opioid withdrawal.Call your healthcare provider right away if you get any of these symptoms:

• Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
• The most common side effects of buprenorphine and naloxone sublingual film include:

• Buprenorphine and naloxone sublingual film may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of buprenorphine and naloxone sublingual film. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‐800‐FDA‐1088.

General information about the safe and effective use of buprenorphine and naloxone sublingual film.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take buprenorphine and naloxone sublingual film for a condition for which it was not prescribed. Do not give buprenorphine and naloxone sublingual film to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

You can ask your doctor or pharmacist for information that is written for health professionals.  

For more information, call 1-877-748-1970 .

This Medication Guide has been approved by the U.S. Food and Drug Administration.  

Buprenorphine and Naloxone Sublingual Film

8 mg/2 mg and 12 mg/3 mg

Revised: April 2023