Class Name(s):

• 28:08.12 Opioid Partial Agonists

Pronunciation:

• (bue'' pre nor' feen)

Brand Name(s):

• Belbuca^®

IMPORTANT WARNING:

Buprenorphine may be habit-forming. This may occur at recommended doses or if it is misused or abused. Do not apply more buprenorphine buccal films, use the buccal films more often, or use the buccal films differently than prescribed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness.

Buprenorphine may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours and any time that your dose is increased. If you have any of the following symptoms, call your doctor immediately: difficulty breathing, shortness of breath, extreme drowsiness, fainting, or loss of consciousness.

Taking certain medications, drinking alcohol, or using street drugs with buprenorphine may increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully.

Buprenorphine may cause serious harm or death if used by other people, especially children. Store buprenorphine in a safe place so that no one else can use it accidentally or on purpose.

Tell your doctor if you are pregnant or plan to become pregnant. If you use buprenorphine regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of using buprenorphine.

WHY is this medicine prescribed?

Buprenorphine is used to relieve severe and persistent pain. Buprenorphine is in a class of medications called opiate partial agonists. It works by changing the way the brain and nervous system respond to pain.

HOW should this medicine be used?

Buprenorphine comes as a buccal film to apply inside the cheek. Apply twice a day. Apply buprenorphine at around the same times every day.

Use buprenorphine buccal exactly as directed.

Your doctor will probably start you on a low dose of buprenorphine, either once daily or every 12 hours, and gradually increase your dose, not more than once every 4 days. Your doctor may decrease your dose if you experience side effects. Tell your doctor if you feel that your pain is not controlled or if you experience side effects during your treatment with buprenorphine.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while using buprenorphine buccal. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available from a community-based program, over the counter, or with a prescription. Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Do not stop using buprenorphine without talking to your doctor. If you suddenly stop using buprenorphine, you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, teary eyes, runny nose, yawning, sweating, chills, muscle and back aches, large pupils (black circles in the center of the eyes), irritability, anxiety, difficulty falling asleep or staying asleep, diarrhea, nausea, vomiting, decreased appetite, stomach cramps, pain in the joints, weakness, fast heartbeat, or rapid breathing.

Buprenorphine is sealed in a foil package. Do not open the package until ready to use. Do not apply buprenorphine if the package seal is broken or the buccal film is cut, damaged, or changed in any way.

Tell your doctor if your pain increases or gets worse or if you have new pain or an increased sensitivity to pain, especially after using buprenorphine. Do not use more of it or use it more often than prescribed by your doctor.

To apply the buccal film, follow these steps:

1. Fold along the dotted line at the top of the foil package. Keep folded and tear down or cut with scissors at the notch in the direction of the scissors on the dotted line. Tear all the way to the bottom. Be careful to avoid cutting and damaging the buccal film when using scissors.
2. Use your tongue to wet the inside of your cheek or rinse your mouth with water to moisten the area in your mouth where you will apply the buccal film. Avoid placing the buccal film in areas with open sores.
3. Remove the buccal film from the package and hold it with clean, dry fingers with the yellow side facing up.
4. Immediately place the yellow side of the buccal film against the inside of your moistened cheek. Press and hold the buccal film in place for 5 seconds and then take your finger away.
5. The buccal film should stick against your cheek. Leave the buccal film in place until it has completely dissolved, usually within 30 minutes after you apply it. Avoid touching or moving the buccal film with your tongue or fingers after you apply it. Do not eat or drink anything until the buccal film has dissolved completely. Do not chew or swallow the buccal film.
6. After the buccal film has dissolved, take a sip of water, swish it around your teeth and gums, and then swallow. Do not brush your teeth for at least one hour after the buccal film has dissolved.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using buprenorphine,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with buprenorphine. Make sure you have discussed any medications you are currently taking or plan to take before starting buprenorphine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking buprenorphine, please get the advice of your doctor or pharmacist.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.
• the following nonprescription or herbal products may interact with buprenorphine: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking this medications before you start using buprenorphine. Do not start this medication while using buprenorphine without discussing it with your healthcare provider.
• tell your doctor if you have or ever had slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems, paralytic ileus (condition in which food does not move through the intestines) or a blockage in the stomach or intestines. Your doctor may tell you not to use buprenorphine.
• tell your doctor if you or an immediate family member have or have ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death); and if you have or have ever had a slow or irregular heartbeat; heart failure; low blood pressure; diabetes; any condition that causes difficulty urinating; seizures; tooth problems, including dental cavities; mouth sores; or gallbladder, pancreas, kidney, thyroid, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking buprenorphine call your doctor immediately. You should not breastfeed while taking buprenorphine.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using buprenorphine.
• you should know that buprenorphine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that buprenorphine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that buprenorphine may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using buprenorphine.
• you should know that buprenorphine may cause serious problems with your teeth, including dental cavities, dental infections, tooth fracture, and tooth loss. Be sure to have regular dental checkups during your treatment with buprenorphine and call your dentist immediately if you have a toothache, mouth pain, or any other problems with your teeth or gums.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Buprenorphine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• dry mouth
• sleepiness
• headache
• decreased sexual desire, inability to get or keep an erection

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• chest pain, changes in heartbeat
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• rash, hives, swelling of your face, tongue or throat, or swelling of the face, mouth, tongue, lips, or throat
• worsening pain, increased sensitivity to pain, or new pain, especially after using buprenorphine
• unusual snoring or long pauses during breaths during sleep
• difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area

Buprenorphine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• slow or shallow breathing or difficulty breathing, unusual snoring
• extreme sleepiness or drowsiness
• unable to respond or wake up
• slow heartbeat
• cold, clammy skin
• muscle weakness
• narrowing or widening of the pupils (black circles in the center of the eye)

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of any medication as soon as it becomes outdated or is no longer needed. Immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, then remove any unused films from their foil packages and flush them down the toilet. Throw away the foil packaging in the trash. Do not flush buprenorphine down the toilet in the foil packages or cartons.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using buprenorphine.

Do not let anyone else use your medication. Buprenorphine is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2026.