Generic Name: Buprenorphine Buccal Film (byoo pre NOR feen)
Brand Name: Belbuca
- This medicine may be habit-forming with long-term use.
- This medicine is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of buprenorphine buccal film can lead to overdose and death. Talk with your doctor.
- You will be watched closely to make sure you do not misuse, abuse, or become addicted to this medicine.
- Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
- This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
- The chance of very bad and sometimes deadly breathing problems may be greater when you first start buprenorphine buccal film or anytime your dose is raised.
- Even one dose of this medicine may be deadly if it is taken by someone else or by accident, especially in children. If buprenorphine buccal film is taken by someone else or by accident, get medical help right away.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- This medicine has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
- Many drugs interact with this medicine and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use buprenorphine buccal film with all of your drugs.
- Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
- Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
- Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
- Misuse or abuse of buprenorphine buccal film by chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Uses of Buprenorphine Buccal Film:
- It is used to ease very bad pain.
- It is only to be used when around-the-clock (continuous) care is needed for a long time. It is also only to be used when other pain drugs do not treat your pain well enough or you cannot take them.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Buprenorphine Buccal Film?
- If you have an allergy to buprenorphine or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
- If you have liver disease.
- If you or a family member have a long QT on ECG.
- If you are taking any of these drugs: Butorphanol, nalbuphine, or pentazocine.
- If you are taking another drug that has the same drug in it.
- If you are taking any of these drugs: Certain drugs to treat a heartbeat that is not normal like amiodarone, disopyramide, dofetilide, procainamide, quinidine, or sotalol.
- If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking buprenorphine buccal film within 14 days of those drugs can cause very bad high blood pressure.
- If you are taking any of these drugs: Linezolid or methylene blue.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take buprenorphine buccal film with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Buprenorphine Buccal Film?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how buprenorphine buccal film affects you.
- To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop buprenorphine buccal film, you will want to slowly stop it as ordered by your doctor.
- If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if buprenorphine buccal film stops working well. Do not take more than ordered.
- This medicine may cause withdrawal symptoms if you are dependent or addicted to narcotics. Talk with your doctor.
- Do not take this medicine with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
- If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
- Very bad and sometimes deadly liver problems have happened with buprenorphine buccal film. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
- This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking buprenorphine buccal film.
- If you are 65 or older, use this medicine with care. You could have more side effects.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking buprenorphine buccal film, call your doctor right away.
- Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.
- This medicine is not approved for use in children. Talk with the doctor.
How is this medicine (Buprenorphine Buccal Film) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- To gain the most benefit, do not miss doses.
- Take buprenorphine buccal film at the same time of day.
- Do not use if the pouch that holds this medicine is torn, open, or not sealed all the way.
- Do not use for fast pain relief or on an as needed basis.
- Do not use for pain relief after surgery if you have not been taking drugs like buprenorphine buccal film.
- Do not use this medicine if it is cut, damaged, or changed in any way.
- Do not put buprenorphine buccal film on any areas with sores.
- Use right after opening.
- Wash your hands before use.
- Be sure your hands are dry before you touch this medicine.
- Wet the inside of your cheek with your tongue or water.
- Place the film inside the mouth on a wet cheek. Place the yellow side of the film against the inside of the cheek. Hold for 5 seconds so it sticks to the cheek. Let it melt.
- Do not touch or move buprenorphine buccal film with your tongue or finger after it has been placed.
- Do not eat or drink until this medicine has melted all the way.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Trouble breathing, slow breathing, or shallow breathing.
- Very bad dizziness or passing out.
- Too much sweat.
- Fast or slow heartbeat.
- A heartbeat that does not feel normal.
- Feeling confused.
- Very hard stools (constipation).
- Feeling very tired or weak.
- Feeling nervous and excitable.
- Fever or chills.
- Sore throat.
- Change in balance.
- Mood changes.
- Very bad belly pain.
- Extra muscle action or slow movement.
- Slurred speech.
- Swelling in the arms or legs.
- Change in eyesight.
- A burning, numbness, or tingling feeling that is not normal.
- Trouble speaking.
- Chest pain or pressure.
- Trouble passing urine.
- Hallucinations (seeing or hearing things that are not there).
- Muscle or joint pain.
- Memory problems or loss.
- Very bad headache.
- Feeling very sleepy.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take buprenorphine buccal film with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
- Taking an opioid drug like this medicine may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
What are some other side effects of Buprenorphine Buccal Film?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Hard stools (constipation).
- Feeling sleepy.
- Upset stomach or throwing up.
- Belly pain.
- Feeling tired or weak.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Buprenorphine Buccal Film?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Store in foil pouch until ready for use.
- Check with your pharmacist about how to throw out unused drugs.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time buprenorphine buccal film is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take buprenorphine buccal film or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to buprenorphine buccal film. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: December 6, 2017
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