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BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM- buprenorphine and naloxone film


  1. What Is The Most Important Information I Should Know About Buprenorphine And Naloxone Sublingual Film?
  2. What Is Buprenorphine And Naloxone Sublingual Film?
  3. Who Should Not Take Buprenorphine And Naloxone Sublingual Film?
  4. Buprenorphine And Naloxone Sublingual Film May Not Be Right For You. Before Taking Buprenorphine And Naloxone Sublingual Film, Tell Your Doctor If You:
  5. Buprenorphine And Naloxone Sublingual Film Include:
  6. How Should I Store Buprenorphine And Naloxone Sublingual Film?
  7. Buprenorphine And Naloxone Sublingual Film?
  8. Active Ingredients:
  9. Inactive Ingredients:
  10. Patient Information

What Is The Most Important Information I Should Know About Buprenorphine And Naloxone Sublingual Film? ⮝

  • Buprenorphine and naloxone sublingual film can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if:
    • You feel faint, dizzy, or confused
    • Your breathing gets much slower than is normal for you
    These can be signs of an overdose or other serious problems.

  • Do not switch from buprenorphine and naloxone sublingual film to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine and naloxone sublingual film is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine and naloxone sublingual film that may be different than other buprenorphine containing medicines you may have been taking.

  • Buprenorphine and naloxone sublingual film contains an opioid that can cause physical dependence.
    • Do not stop taking buprenorphine and naloxone sublingual film without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
    • Physical dependence is not the same as drug addiction.
    • Buprenorphine and naloxone sublingual film is not for occasional or as needed use.

  • An overdose and even death can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using buprenorphine and naloxone sublingual film. Ask your doctor what you should do if you are taking one of these.

  • Call a doctor or get emergency help right away if you:
    • Feel sleepy and uncoordinated
    • Have blurred vision
    • Have slurred speech
    • Cannot think well or clearly
    • Have slowed reflexes and breathing

  • Do not inject ( shoot-up ) buprenorphine and naloxone sublingual film.
    • Injecting buprenorphine and naloxone sublingual film may cause life-threatening infections and other serious health problems.
    • Injecting buprenorphine and naloxone sublingual film may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

  • In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with buprenorphine and naloxone sublingual film.

What Is Buprenorphine And Naloxone Sublingual Film? ⮝

Buprenorphine and naloxone sublingual film is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

Buprenorphine and naloxone sublingual film is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your buprenorphine and naloxone sublingual film in a safe place to protect it from theft. Never give your buprenorphine and naloxone sublingual film to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

It is not known if buprenorphine and naloxone sublingual film is safe or effective in children.

Who Should Not Take Buprenorphine And Naloxone Sublingual Film? ⮝

Do not take buprenorphine and naloxone sublingual film if you are allergic to buprenorphine or naloxone.

Buprenorphine And Naloxone Sublingual Film May Not Be Right For You. Before Taking Buprenorphine And Naloxone Sublingual Film, Tell Your Doctor If You: ⮝

  • Have liver or kidney problems
  • Have trouble breathing or lung problems
  • Have an enlarged prostate gland (men)
  • Have a head injury or brain problem
  • Have problems urinating
  • Have a curve in your spine that affects your breathing
  • Have gallbladder problems
  • Have adrenal gland problems
  • Have Addison's disease
  • Have low thyroid (hypothyroidism)
  • Have a history of alcoholism
  • Have mental problems such as hallucinations (
  • Respiratory problems. You have a higher risk of death and coma if you take buprenorphine and naloxone sublingual film with other medicines, such as benzodiazepines.
  • Sleepiness, dizziness, and problems with coordination
  • Dependency or abuse
  • Liver problems. Call your doctor right away if you notice any of these signs of liver problems: Your skin or the white part of your eyes turning yellow (jaundice), urine turning dark, stools turning light in color, you have less of an appetite, or you have stomach (abdominal) pain or nausea. Your doctor should do tests before you start taking and while you take buprenorphine and naloxone sublingual film.
  • Allergic reaction. You may have a rash, hives, swelling of the face, wheezing, or a loss of blood pressure and consciousness. Call a doctor or get emergency help right away.
  • Opioid withdrawal.This can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, and muscle aches. Tell your doctor if you develop any of these symptoms.
  • Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.

Common side effects of

Buprenorphine And Naloxone Sublingual Film Include: ⮝

  • Nausea
  • Vomiting
  • Drug withdrawal syndrome
  • Headache
  • Sweating
  • Numb mouth
  • Constipation
  • Swollen and/or painful tongue
  • The inside of your mouth is more red than normal
  • Intoxication (feeling lightheaded or drunk)
  • Disturbance in attention
  • Irregular heart beat (palpitations)
  • Decrease in sleep (insomnia)
  • Blurred vision
  • Back pain
  • Fainting
  • Dizziness
  • Sleepiness

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of buprenorphine and naloxone sublingual film. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Buprenorphine And Naloxone Sublingual Film? ⮝


  • Store buprenorphine and naloxone sublingual film at 25 C (77 F); excursions permitted to 15 C to 30 C (59 to 86 F).
  • Keep buprenorphine and naloxone sublingual film in a safe place, out of the sight and reach of children.

How should I dispose of unused

Buprenorphine And Naloxone Sublingual Film? ⮝

  • Dispose of unused buprenorphine and naloxone sublingual film as soon as you no longer need them.
  • Unused films should be removed from the foil pouch and flushed down the toilet.
  • Do not flush the buprenorphine and naloxone sublingual film foil pouch down the toilet.

If you need help with disposal of buprenorphine and naloxone sublingual film, call 1-866-770-3024.

General information about the safe and effective use ofbuprenorphine and naloxone sublingual film.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take buprenorphine and naloxone sublingual film for a condition for which it was not prescribed. Do not give buprenorphine and naloxone sublingual film to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about buprenorphine and naloxone sublingual film. If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for health professionals.

For more information call 1-866-770-3024.

Active Ingredients: ⮝

buprenorphine and naloxone.

Inactive Ingredients: ⮝

polyethylene oxide, maltitol, citric acid monohydrate, sodium citrate dihydrate, acesulfame potassium, FD&C yellow #6, lime flavor and white ink. The white ink contains ethyl alcohol, propylene glycol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, and ammonium hydroxide, and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Made in USA

Distributed by
Alvogen, Inc.
Pine Brook, NJ 07058 USA

PL355-01
Rev. 12/2018

Patient Information ⮝

Advise patients to read the FDA-approved patient labeling (Medication Guide).

Safe Use

Before initiating treatment with buprenorphine and naloxone sublingual film, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time buprenorphine and naloxone sublingual film is dispensed because new information may be available.

Buprenorphine and naloxone sublingual film must be administered whole. Advise patients not to cut, chew, or swallow buprenorphine and naloxone sublingual film.
Inform patients and caregivers that potentially fatal additive effects may occur if buprenorphine and naloxone sublingual film is used with benzodiazepines or other CNS depressants, including alcohol. Counsel patients that such medications should not be used concomitantly unless supervised by a health care provider[see Warnings and Precautions (5.2,5.3),Drug Interactions (7)].
Advise patients that buprenorphine and naloxone sublingual film contains an opioid that can be a target for people who abuse prescription medications or street drugs. Caution patients to keep their films in a safe place, and to protect them from theft.
Instruct patients to keep buprenorphine and naloxone sublingual film in a secure place, out of the sight and reach of children. Accidental or deliberate ingestion by a child may cause respiratory depression that can result in death. Advise patients to seek medical attention immediately if a child is exposed to buprenorphine and naloxone sublingual film.
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications[see Drug Interactions (7)].
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms[see Warnings and Precautions (5.6)].
Advise patients to never give buprenorphine and naloxone sublingual film to anyone else, even if he or she has the same signs and symptoms. It may cause harm or death.
Advise patients that selling or giving away this medication is against the law.
Caution patients that buprenorphine and naloxone sublingual film may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving or operating machinery. Caution should be taken especially during drug induction and dose adjustment and until individuals are reasonably certain that buprenorphine therapy does not adversely affect their ability to engage in such activities[see Warnings and Precautions (5.13)].
Advise patients not to change the dosage of buprenorphine and naloxone sublingual film without consulting their healthcare provider.
Advise patients to take buprenorphine and naloxone sublingual film once a day.
Advise patients that if they miss a dose of buprenorphine and naloxone sublingual film they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at the regular time.
Inform patients that buprenorphine and naloxone sublingual film can cause drug dependence and that withdrawal signs and symptoms may occur when the medication is discontinued.
Advise patients seeking to discontinue treatment with buprenorphine for opioid dependence to work closely with their healthcare provider on a tapering schedule and inform them of the potential to relapse to illicit drug use associated with discontinuation of opioid agonist/partial agonist medication-assisted treatment.
Advise patients that, like other opioids, buprenorphine and naloxone sublingual film may produce orthostatic hypotension in ambulatory individuals[see Warnings and Precautions (5.14)].
Advise patients to inform their healthcare provider if any other prescription medications, over-the-counter medications, or herbal preparations are prescribed or currently being used[see Drug Interactions (7)].
Advise women that if they are pregnant while being treated with buprenorphine and naloxone sublingual film, the baby may have signs of withdrawal at birth and that withdrawal is treatable[see Warnings and Precautions (5.5),Use in Specific Populations (8.1)].
Advise women who are breastfeeding to monitor the infant for drowsiness and difficulty breathing[see Use in Specific Populations (8.2)].
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible[seeUse in Specific Populations (8.3)].
Advise patients to inform their family members that, in the event of emergency, the treating healthcare provider or emergency room staff should be informed that the patient is physically dependent on an opioid and that the patient is being treated with buprenorphine and naloxone sublingual film.

Disposal of Unused Buprenorphine and Naloxone Sublingual Films

Unused buprenorphine and naloxone sublingual films should be disposed of as soon as they are no longer needed. Unused films should be flushed down the toilet.

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