Buprenorphine Buccal, Oral

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KEY POINTS

• This medicine is used to treat long-term, around-the-clock, severe pain. Take it exactly as directed. Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death.
• This medicine may cause serious or life-threatening breathing problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with alcohol or other medicines that make you sleepy or slow your breathing can cause coma or death. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: partial narcotic (opioid) agonist

Generic and brand names: buprenorphine hydrochloride buccal, oral; Belbuca

What is this medicine used for?

This medicine is taken by mouth to treat long-term, around-the-clock, severe pain. This medicine is NOT used for mild pain, pain that you have once in a while, or pain that is expected to last a short time (such as after surgery).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• A stroke, head injury, or brain tumor
• Addison's disease
• Heart disease or irregular heartbeat
• Liver or kidney disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Low blood pressure
• Low levels of potassium or magnesium in your blood
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Mental health problems such as depression or bipolar disorder
• Mouth sores from cancer treatment
• Pancreas or gallbladder problems
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. Long-term use of this medicine during pregnancy can cause withdrawal symptoms in your newborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider.

Do not switch from this medicine to other medicines that contain buprenorphine without talking with your healthcare provider. The amount in this medicine is not the same as in other medicines.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine comes as a buccal (between cheek and gum) film (thin sheet). Carefully follow the instructions included in the medicine package for how to use this medicine. Do not put the film on a sore or scratched area in your mouth.

Do not cut, chew, or swallow the medicine. The medicine will not work if chewed or swallowed and may cause withdrawal symptoms. Do not eat or drink anything until the medicine dissolves (usually within 30 minutes).

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness; pinpoint pupils; confusion; trouble breathing or breathing that stops, cold and clammy skin; muscle weakness; irregular or slow heartbeat; fainting; seizures; coma.

What should I watch out for?

Do not take other medicines unless you check with your healthcare provider first. Taking this medicine with alcohol or medicines that make you sleepy or slow your breathing can cause life-threatening side effects. Tell your healthcare if you take any kind of sleeping pill, pain medicine, muscle relaxant, nausea medicine, or medicine to treat anxiety, depression, or seizures. This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as migraine medicines, some cough medicines, St. John’s wort, and others. Make sure that your healthcare providers know ALL of the medicines that you take.

This medicine may cause life-threatening or fatal breathing problems. Taking this medicine for a long time may also cause a rare but very serious adrenal gland problem or decreased sex hormone levels. Talk with your healthcare provider about this.

Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine increases your chance of side effects. If you use this medicine regularly for a long time or in high doses, ask your healthcare provider how to reduce your dose gradually. Follow your provider’s instructions about how to stop taking the medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else. Keep this medicine away from children. Accidental use by a child can cause death.

Your healthcare provider will want to check you regularly while you are receiving this medicine. You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may lessen this effect.

This medicine may make you constipated. Drinking lots of water, exercising, and taking more fiber may help. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing; slow or shallow breathing; extreme sleepiness; confusion; seizures; hallucinations (seeing or hearing things that are not there); fast, slow, or irregular heartbeat; yellowing of your skin or eyes; dark urine; light-colored bowel movements; severe stomach pain; severe nausea or vomiting; severe constipation; severe dizziness or fainting; problems walking or talking; unusual mood changes, unexplained swelling in arm or legs; trembling; pinpoint pupils; blurred vision.

Other: Nausea, vomiting, headache, constipation, mild drowsiness or dizziness, trouble sleeping, sweating, flushing, nervousness, decreased appetite, change in sexual desire or ability, runny nose, sore throat, mouth numbness or burning.

What products might interact with this medicine?

This medicine may interact with MANY other medicines and cause life-threatening side effects. This list does not include all possible medicines that may interact. Do not start or stop ANY medicine unless you check with your healthcare provider or pharmacist first. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Tell your healthcare provider all the products you take, for example:

• Alcohol
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), rifampin (Rifadin), telithromycin (Ketek), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), and others
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), mirtazapine (Remeron), nefazodone, trazodone, and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), gabapentin (Neurontin), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), and others
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), verapamil (Calan, Covera, Verelan), and others
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), nilotinib (Tasigna), and others
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and others
• Doxepin (Silenor)
• Eluxadoline (Viberzi)
• Flibanserin (Addyi)
• Heart medicines such as digoxin (Lanoxin), dronedarone (Multaq), quinidine, and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Linezolid (Zyvox)
• Lorcaserin (Belviq)
• Lumacaftor/ivacaftor (Orkambi)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines that block or may partially block the effect of narcotic pain medicines such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv), bupropion/naltrexone (Contrave), naltrexone (ReVia, Vivitrol), and others
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta), and others
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), naratriptan (Amerge), sumatriptan (Alsuma, Imitrex, Sumavel), and others
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), tizanidine (Zanaflex), and others
• Naloxegol (Movantik)
• Narcotic allergy, cold, or cough medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), promethazine/codeine (Phenergan with codeine), and others
• Natural remedies such as gotu kola, kava, St. John's wort, valerian, and others
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), promethazine, and others
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Rasagiline (Azilect)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Tedizolid (Sivextro)

DO NOT drink alcohol while you are taking this medicine.

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

When you have finished treatment with this medicine, ask your pharmacist or healthcare provider how to safely dispose of the medicine.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.