Medication Guide
BUNAVAIL® (bue-nah-vale) (buprenorphine and naloxone buccal film), CIII |
| IMPORTANT: Keep BUNAVAIL in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally uses BUNAVAIL, get emergency help or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children. |
What is the most important information I should know about BUNAVAIL?
- BUNAVAIL contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.
- Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of BUNAVAIL by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid.
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BUNAVAIL may cause serious and life-threatening breathing problems. Get emergency help right away if you:
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- feel faint
- feel dizzy
- are confused
- feel sleepy or uncoordinated
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- have blurred vision
- have slurred speech
- are breathing slower than normal
- cannot think well or clearly
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Do not take BUNAVAIL with certain medicines. Taking BUNAVAIL with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
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Do not inject ("shoot-up") BUNAVAIL. Injecting BUNAVAIL may cause life-threatening infections and other serious health problems. Injecting BUNAVAIL may cause sudden serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
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Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking to your healthcare provider. The amount of buprenorphine in a dose of BUNAVAIL may not be the same as in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of BUNAVAIL that may be different than other buprenorphine containing medicines you may have been taking.
- Do not stop taking BUNAVAIL suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine (physical dependence). Physical dependence is not the same as drug addiction.
- In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with BUNAVAIL.
- Never give anyone else your BUNAVAIL. They could die from taking it. Selling or giving away BUNAVAIL is against the law.
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Store BUNAVAIL securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
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What is BUNAVAIL?
- BUNAVAIL is a prescription medicine used to treat opioid addiction in adults and is part of a complete treatment program that also includes counseling and behavioral therapy.
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Who should not take BUNAVAIL?
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Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone.
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| Before taking BUNAVAIL, tell your healthcare provider about all of your medical conditions, including if you have: |
- trouble breathing or lung problems
- a curve in your spine that affects your breathing
- Addison's disease
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- an enlarged prostate (men)
- problems urinating
- liver, kidney, or gallbladder problems
- alcoholism
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- a head injury or brain problem
- mental health problems
- adrenal gland or thyroid gland problems
- tooth problems, including a history of cavities
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Tell your healthcare provider if you are:
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pregnant or plan to become pregnant. If you take BUNAVAIL while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life-threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
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breastfeeding. BUNAVAIL can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take BUNAVAIL. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with BUNAVAIL.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. |
How should I take BUNAVAIL?
- After BUNAVAIL is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.
- Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking BUNAVAIL.
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Read the Instructions for Use at the end of this Medication Guide for detailed instructions on how to take BUNAVAIL.
- Take BUNAVAIL exactly as prescribed by your healthcare provider. Your healthcare provider may change your dose after seeing how it affects you. Do not change your dose unless your healthcare provider tells you to change it.
- Do not take BUNAVAIL more often than prescribed by your healthcare provider.
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BUNAVAIL is not for occasional or "as needed" use.
- Use the entire BUNAVAIL sublingual film. Do not cut, tear, chew, or swallow the sublingual film.
- If you miss a dose of BUNAVAIL, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
- Dispose of expired, unwanted, or unused BUNAVAIL by removing BUNAVAIL from the foil packaging, and promptly flushing down the toilet (if a drug take-back option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
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If you take too much BUNAVAIL or overdose, get emergency medical help right away.
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What should I avoid while taking BUNAVAIL?
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Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you. BUNAVAIL can cause drowsiness and slow reaction times. BUNAVAIL can make you sleepy, dizzy, or lightheaded.
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You should not drink alcohol or use prescription or over-the-counter medicines that contain alcohol while using BUNAVAIL, because this can lead to loss of consciousness or even death.
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What are possible side effects of BUNAVAIL?
BUNAVAIL can cause serious side effects including:
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Trouble breathing. Taking BUNAVAIL with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants can cause breathing problems that can lead to coma and death.
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Sleepiness, dizziness, and problems with coordination.
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Physical dependence or abuse.
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Liver problems. Call your healthcare provider right away if you notice any of these symptoms:
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- your skin or the white part of your eyes turns yellow (jaundice)
- dark or "tea-colored" urine
- light colored stools (bowel movements)
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- loss of appetite
- pain, aching, or tenderness on the right side of your stomach area
- nausea
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| Your healthcare provider should do blood tests to check the liver before you start taking and while you take BUNAVAIL. |
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Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, low blood pressure, or loss of consciousness. Call your healthcare provider or get emergency help right away.
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Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms:
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- shaking
- sweating more than normal
- feeling hot or cold more than normal
- runny nose
- watery eyes
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- goose bumps
- diarrhea
- vomiting
- muscle aches
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Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
The most common side effects of BUNAVAIL include: |
- headache
- nausea
- vomiting
- constipation
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- pain
- increased sweating
- decrease in sleep (insomnia)
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BUNAVAIL sublingual film may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of BUNAVAIL.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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General information about the safe and effective use of BUNAVAIL.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BUNAVAIL for a condition for which it was not prescribed. Do not give BUNAVAIL to other people, even if they have the same symptoms you have. It may harm them, and it is against the law. You can ask your pharmacist or healthcare provider or for information that is written for health professionals. |