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BUPRENORPHINE HCL AND NALOXONE HCL- buprenorphine and naloxone tablet


  1. Manufactured By:
  2. Distributed By:
  3. Important:
  4. Uprenorphine And Naloxone Sublingual Tablets?
  5. Uprenorphine And Naloxone Sublingual Tablets, Tell Your Doctor If You:
  6. Can Cause Serious Side Effects Including:
  7. Uprenorphine And Naloxone Sublingual Tablets Include:
  8. Active Ingredients:
  9. Inactive Ingredients:
  10. Patient Information

Manufactured By: 

Amneal Pharmaceuticals of New York, LLC

Hauppauge, NY 11788

Distributed By: 

Amneal Pharmaceuticals LLC

Glasgow, KY 42141

Rev. 01-2018-08

Important: 

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

Read this Medication Guide that comes with buprenorphine and naloxone sublingual tablets 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 tablets.

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

What is the most important information I should know about b

Uprenorphine And Naloxone Sublingual Tablets? 

  • Buprenorphine and naloxone sublingual tablets 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 tablets to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine and naloxone sublingual tablets may not be 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 tablets that may be different than other buprenorphine containing medicines you may have been taking.
  • Buprenorphine and naloxone sublingual tablets contain an opioid that can cause physical dependence.
    • Do not stop taking buprenorphine and naloxone sublingual tablets 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 tablets are 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 tablets. 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 tablets.
    • Injecting buprenorphine and naloxone sublingual tablets may cause life-threatening infections and other serious health problems.
    • Injecting buprenorphine and naloxone sublingual tablets may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
  • In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with buprenorphine and naloxone sublingual tablets.
  • Never give anyone else your buprenorphine and naloxone sublingual tablets. They could die from taking it. Selling or giving away buprenorphine and naloxone sublingual tablets is against the law.
  • Store buprenorphine and naloxone sublingual tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

What are b

Uprenorphine And Naloxone Sublingual Tablets, 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 tablets 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 tablets.
      • You should not drink alcoholwhile using buprenorphine and naloxone sublingual tablets, as this can lead to loss of consciousness or even death.

      What are the possible side effects of b

Can Cause Serious Side Effects Including: 

  • Respiratory problems.You have a higher risk of death and coma if you take buprenorphine and naloxone sublingual tablets 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 tablets.
  • 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 b

Uprenorphine And Naloxone Sublingual Tablets 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 tablets. 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 b

Active Ingredients: 

buprenorphine hydrochloride, USP and naloxone hydrochloride dihydrate, USP

Inactive Ingredients: 

acesulfame potassium, anhydrous citric acid, artificial lemon flavor, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, mannitol, povidone, sodium citrate and starch (corn starch).

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

Manufactured by:
Amneal Pharmaceuticals of New York, LLC
Hauppauge, NY 11788

Distributed by:
Amneal Pharmaceuticals LLC
Glasgow, KY 42141

Rev. 10-2019-09

Patient Information 

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

Storage and Disposal

Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Buprenorphine and Naloxone Sublingual Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home[seeWarnings and Precautions (5.1,5.4),Drug Abuse and Dependence(9.2)]. Inform patients that leaving Buprenorphine and Naloxone Sublingual Tablets unsecured can pose a deadly risk to others in the home.

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Buprenorphine and Naloxone Sublingual Tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Safe Use

Before initiating treatment with Buprenorphine and Naloxone Sublingual Tablets, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time buprenorphine and naloxone sublingual tablets are dispensed because new information may be available.

  • Buprenorphine and Naloxone Sublingual Tablets must be administered whole. Advise patients not to cut, chew, or swallow Buprenorphine and Naloxone Sublingual Tablets.
  • Inform patients and caregivers that potentially fatal additive effects may occur if Buprenorphine and Naloxone Sublingual Tablets are 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[seeWarnings and Precautions (5.2,5.3),Drug Interactions (7)].
  • Advise patients that Buprenorphine and Naloxone Sublingual Tablets contain an opioid that can be a target for people who abuse prescription medications or street drugs, to keep their tablets in a safe place, and to protect them from theft.
  • Instruct patients to keep Buprenorphine and Naloxone Sublingual Tablets 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 Tablets.
  • 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 Tablets 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 Tablets 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 Tablets without consulting their healthcare provider.
  • Advise patients that if they miss a dose of Buprenorphine and Naloxone Sublingual Tablets 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.
  • Advise patients to take Buprenorphine and Naloxone Sublingual Tablets once a day.
  • Inform patients that Buprenorphine and Naloxone Sublingual Tablets 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 Tablets 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 Tablets, 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 Tablets.


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