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BUPRENORPHINE AND NALOXONE film


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

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 healthcare provider[seeWarnings 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[seeDrug 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[seeWarnings 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[seeWarnings 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[seeWarnings 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[seeDrug 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[seeWarnings and Precautions (5.5),Use in Specific Populations (8.1)].
Advise women who are breastfeeding to monitor the infant for drowsiness and difficulty breathing[seeUse 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.

Important: 

Keep buprenorphine and naloxone sublingual film 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 buprenorphine and naloxone sublingual film, get emergency help right away.

Read this Medication Guide that comes with buprenorphine and naloxone sublingual film before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor. Talk to your doctor or pharmacist if you have questions about buprenorphine and naloxone sublingual film.

Share the important information in this Medication Guide with members of your household.

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:
o
You feel faint, dizzy, or confused
o
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.
o
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.
o
Physical dependence is not the same as drug addiction.
o
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:
o
Feel sleepy and uncoordinated
o
Have blurred vision
o
Have slurred speech
o
Cannot think well or clearly
o
Have slowed reflexes and breathing
Do not inject ( shoot-up ) buprenorphine and naloxone sublingual film.
o
Injecting buprenorphine and naloxone sublingual film may cause life-threatening infections and other serious health problems.
o
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 (

Always take buprenorphine and naloxone sublingual film exactly as your doctor tells you. Your doctor may change your dose after

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you.Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take buprenorphine and naloxone sublingual film.
You should not drink alcoholwhile using buprenorphine and naloxone sublingual film, as this can lead to loss of consciousness or even death.

Buprenorphine And Naloxone Sublingual Film Can Cause Serious Side Effects, Including: 

Store buprenorphine and naloxone sublingual film at room temperature between 20 to 25 C (68 to 77 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 1-877-446-3679 (1-877-4-INFO-RX).

General information about the safe and effective use of buprenorphine 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 Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

Active Ingredients: 

buprenorphine and naloxone.

Inactive Ingredients: 

polyethylene oxide, polyethylene glycol, hypromellose, maltitol, acesulfame potassium, lemon-lime flavor, citric acid anhydrous, trisodium citrate dihydrate, FD&C Yellow No. 6, and white ink. In addition, the white imprinting ink contains titanium dioxide and hypromellose.

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

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 5/2018
BNSF:R3



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