Buprenorphine Buccal Film

What is this medication?

BUPRENORPHINE (byoo pre NOR feen) treats severe, chronic pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by blocking pain signals in the brain. It belongs to a group of medications called opioids. This medication is long-acting. Do not use it to treat sudden pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Belbuca

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Brain tumor
• Dental or gum disease
• Drug abuse or addiction
• Gallbladder disease
• Head injury
• Heart disease
• If you often drink alcohol
• Irregular heartbeat or rhythm
• Liver disease
• Low adrenal gland function
• Lung disease, asthma, or breathing problem
• Mouth sores
• Pancreatic disease
• Seizures
• Stomach or intestine problems
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to buprenorphine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label. Wet the inside of your cheek with tongue or rinse mouth with water before use. Open package with dry hands just before you are ready to use. Use the tip of a dry finger to put the film in the mouth with the yellow side facing the cheek. Hold it in place for 5 seconds. Then, allow it to dissolve which usually takes 30 minutes. Do not move or touch the film with fingers or tongue. Do not eat or drink until the film has dissolved. Do not cut, chew, or swallow the film. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Safinamide
• Samidorphan
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Certain antibiotics like clarithromycin, erythromycin
• Certain antivirals for hepatitis or HIV
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression or psychotic disorders
• Certain medications for fungal infections like fluconazole, ketoconazole, posaconazole
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for nausea or vomiting like dolasetron, ondansetron, palonosetron
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles like cyclobenzaprine, metaxalone
• Methylene blue (injected into a vein)
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)
• Other narcotic medications for pain or cough
• Phenothiazines like chlorpromazine, prochlorperazine
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a nonmedical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

If you take other medications that also cause drowsiness such as other narcotic pain medications, benzodiazepines, or other medications for sleep, you may have more side effects. Give your care team a list of all medications you use.

Talk to your care team about naloxone and how to get it. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other medications or substances, such as alcohol. Know the symptoms of an overdose, such as trouble breathing, being unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

Tell your dentist that you are taking this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Tooth decay—change in tooth color, bad breath, sensitive gums or teeth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it, or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, remove it from the packaging and flush it down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.