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Generic Name: buprenorphine (oral/buccal) (BUE pre NOR feen (OR al / BUK al))
Brand Names: Belbuca

What is Belbuca?

Belbuca (buprenorphine) is an opioid medication. An opioid is sometimes called a narcotic.

Belbuca buccal films are used for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines. This medicine is not for use on an as-needed basis for occasional pain.

Buccal administration is where a Belbuca film is held in the buccal area (in the cheek) and the buprenorphine passes through the tissues which line the mouth and enters directly into the bloodstream.

Belbuca is NOT used to treat pain that is not around-the-clock.

Important information

Belbuca can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Buprenorphine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using Belbuca without a prescription.

Buprenorphine may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Before taking this medicine

You should not use Belbuca if you have used another narcotic drug within the past 4 hours, if you are allergic to buprenorphine, or if you have:

  • severe asthma or trouble breathing; or

  • a blockage in your digestive tract, including a bowel obstruction called paralytic ileus.

Some medicines can interact with buprenorphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure Belbuca is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • liver disease (especially hepatitis B or C);

  • kidney disease;

  • enlarged prostate, urination problems;

  • problems with your gallbladder, pancreas, or thyroid;

  • long QT syndrome, or if you take heart rhythm medication;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • mouth sores caused by cancer;

  • a history of head injury, brain tumor, or seizures;

  • a history of drug abuse, methadone use, alcohol addiction, or mental illness; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

It is not known whether Belbuca will harm an unborn baby. If you use Belbuca while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Belbuca.

Belbuca is not approved for use by anyone younger than 18 years old.

How should I take Belbuca?

Use Belbuca exactly as prescribed by your doctor. Follow all directions on your prescription label. Buprenorphine can slow or stop your breathing. Never use Belbuca in larger amounts, or for longer than prescribed. Your doctor may occasionally change your dose to make sure you get the best results. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Buprenorphine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Belbuca is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

To use a Belbuca buccal film:

  • wet the inside of your cheek with your tongue or rinse your mouth with water to moisten the area in your mouth before you place a film;

  • hold the buccal film with clean, dry fingers with the yellow side facing up;

  • using a finger, place the yellow side of the buccal film against the inside of your moistened cheek. Press and hold the Belbuca buccal film in place for 5 seconds and then take your finger away;

  • the buccal film will stick to the inside of your cheek;

  • leave the buccal film in place until it has completely dissolved, usually within 30 minutes after you apply it.

Avoid eating food or drinking liquids until buccal film has completely dissolved in your mouth. Avoid touching or moving the buccal film with your tongue or finger after it is in place. Do not chew or swallow Belbuca. Do not chew or cut a film, and do not swallow it whole.

While using Belbuca, you may need frequent blood tests to check your liver function.

If you need surgery, tell the surgeon ahead of time that you are using Belbuca. You may need to stop using the medicine for a short time.

Do not stop using Belbuca suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Belbuca.

Store at room temperature away from moisture and heat. Keep the medicine in a place where a child cannot get to it. Keep track of the amount of medicine used from each new bottle. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover Belbuca films. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.

Dosage Information (comprehensive)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A buprenorphine overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, muscle weakness, pinpoint pupils, fainting, slow heart rate, weak pulse, deep sighs, snoring that is new or unusual, weak or shallow breathing (breathing may stop).

What should I avoid while taking Belbuca?

Avoid applying the buccal film to an area where you have a mouth sore.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with buprenorphine. Check your food and medicine labels to be sure these products do not contain alcohol.

Belbuca may impair your thinking or reactions. Avoid driving or operating machinery until you know how Belbuca will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Belbuca side effects

Get emergency medical help if you have signs of an allergic reaction to Belbuca: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

  • chest pain, fast heart rate, trouble breathing;

  • weak or shallow breathing, feeling like you might pass out;

  • severe constipation;

  • infertility, missed menstrual periods;

  • impotence, sexual problems, loss of interest in sex;

  • low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness;

  • opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain; or

  • liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Common Belbuca side effects may be more likely to occur, such as:

  • constipation, nausea, vomiting;

  • headache, dizziness, drowsiness;

  • increased sweating;

  • sleep problems (insomnia); or

  • pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

What other drugs will affect Belbuca?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications - opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

  • drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Belbuca.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Belbuca only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 1.03. Revision Date: 2016-09-28, 1:36:30 PM.