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Buprenorphine and naloxone film

Generic Name: buprenorphine and naloxone (BUE-pre-NOR-feen & nal-OX-one)
Brand Name: Bunavail

Buprenorphine and naloxone film is used for:

Treating opioid dependence. It should be used as part of a complete treatment plan. It may also be used for other conditions as determined by your doctor.

Buprenorphine and naloxone film is an opioid (narcotic) partial agonist-antagonist. It works in the brain and nervous system to help prevent withdrawal symptoms in someone who has stopped taking narcotics.

Do NOT use buprenorphine and naloxone film if:

  • you are allergic to any ingredient in buprenorphine and naloxone film

Contact your doctor or health care provider right away if any of these apply to you.

Before using buprenorphine and naloxone film:

Some medical conditions may interact with buprenorphine and naloxone film. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of blood or electrolyte problems, breathing or lung problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), low blood oxygen levels, high blood carbon dioxide levels, curvature of the spine (eg, kyphoscoliosis), certain heart problems (eg, cor pulmonale), thyroid problems, adrenal gland problems (eg, Addison disease), liver problems (eg, hepatitis B or C), abnormal liver enzyme tests, kidney problems, an enlarged prostate gland, trouble urinating, a blockage of your bladder or urethra, seizures, or gallbladder problems
  • if you have a history of stomach or bowel problems (eg, inflammatory bowel disease), blockage, or surgery
  • if you have slow or shallow breathing, severe drowsiness, stomach problems, or poor health
  • if you have a history of recent head injury, growths in the brain (eg, tumor, lesion), or increased pressure in the brain
  • if you have a history of mental or mood problems (eg, hallucinations), suicidal thoughts or behaviors, or drug or alcohol abuse; or if you are in alcohol withdrawal
  • if you have never taken buprenorphine or an opioid (narcotic) pain medicine before

Some MEDICINES MAY INTERACT with buprenorphine and naloxone film. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole, voriconazole), benzodiazepines (eg, diazepam), boceprevir, delavirdine, HIV protease inhibitors (eg, atazanavir, ritonavir), macrolide antibiotics (eg, erythromycin), narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), or telaprevir because they may increase the risk of buprenorphine and naloxone film's side effects
  • Carbamazepine, efavirenz, etravirine, nevirapine, phenobarbital, phenytoin, or rifamycins (eg, rifampin) because they may decrease buprenorphine and naloxone film's effectiveness or withdrawal symptoms may occur
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if buprenorphine and naloxone film may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use buprenorphine and naloxone film:

Use buprenorphine and naloxone film as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Buprenorphine and naloxone film comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get buprenorphine and naloxone film refilled.
  • Before you place the film, use your tongue to wet the inside of your cheek. You may also rinse your mouth with water.
  • Do not cut, tear, chew, or swallow the film whole. To place the film, hold it with the text facing up. Place the side of the film with the writing against the inside of your cheek. Press and hold the film in place for 5 seconds. Keep the film in place and allow it to completely dissolve. Do not eat or drink while the film is dissolving.
  • Do not touch the film with your tongue or finger once it has been placed.
  • Do not remove the film from the foil package until you are ready to take buprenorphine and naloxone film. Make sure that your hands are dry when you open the foil package.
  • To open the foil pouch, fold along the dotted line and tear down at the slit or cut with scissors along the arrow.
  • If your doctor tells you to use more than 1 film at the same time, place the additional film on the inside of your cheek on the opposite side from the first film. If you need to use several films to make up your dose, do not place more than 2 films on the inside of 1 cheek at a time.
  • Do not suddenly stop taking buprenorphine and naloxone film without checking with your doctor. You may experience withdrawal symptoms, such as pain, cramps, vomiting, diarrhea, anxiety, sleeping problems, and cravings. If you need to stop buprenorphine and naloxone film, your doctor may need to gradually lower your dose.
  • Buprenorphine and naloxone film should only be taken by mouth. Life-threatening and sometimes fatal side effects may occur if buprenorphine and naloxone film is administered by injection.
  • Take buprenorphine and naloxone film on a regular schedule to get the most benefit from it.
  • Taking buprenorphine and naloxone film at the same time each day will help you remember to take it.
  • Buprenorphine and naloxone film should be disposed of properly if it is no longer needed. Ask your doctor, nurse, or pharmacist how to appropriately dispose of buprenorphine and naloxone film.
  • If you miss a dose of buprenorphine and naloxone film, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless your doctor tells you to. If you are not sure what to do if you miss a dose, check with your doctor.

Ask your health care provider any questions you may have about how to use buprenorphine and naloxone film.

Important safety information:

  • Buprenorphine and naloxone film may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use buprenorphine and naloxone film with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using buprenorphine and naloxone film.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using buprenorphine and naloxone film; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not inject buprenorphine and naloxone film. Doing so may cause severe withdrawal symptoms, severe breathing problems, and death.
  • Buprenorphine and naloxone film may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do NOT change your dose, use more often than prescribed, or suddenly stop taking buprenorphine and naloxone film without checking with your doctor.
  • Do not switch to another doseform of buprenorphine and naloxone film without talking to your doctor.
  • Tell your doctor or dentist that you take buprenorphine and naloxone film before you receive any medical or dental care, emergency care, or surgery.
  • Accidental exposure of buprenorphine and naloxone film may cause death. Keep away from children. If buprenorphine and naloxone film is taken by accident, get medical help right away.
  • CHILDREN may be at greater risk of severe and possibly fatal breathing problems. If a child takes buprenorphine and naloxone film, seek medical attention immediately.
  • Severe and sometimes fatal liver problems have happened with buprenorphine and naloxone film. Call your doctor right away if you have symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-upper stomach pain, unusual nausea, yellowing of the eyes or skin).
  • Lab tests, including liver function, may be performed while you use buprenorphine and naloxone film. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use buprenorphine and naloxone film with caution in the ELDERLY; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using buprenorphine and naloxone film while you are pregnant. Use of buprenorphine and naloxone film during pregnancy may cause dependence in the fetus or newborn. This can lead to withdrawal in the newborn baby. Discuss any questions or concerns with your doctor. Buprenorphine and naloxone film is found in breast milk. If you are or will be breast-feeding while you use buprenorphine and naloxone film, check with your doctor. Discuss any possible risks to your baby.

Some people who use buprenorphine and naloxone film for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking buprenorphine and naloxone film suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; and vomiting.

Possible side effects of buprenorphine and naloxone film:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; mild stomach pain; nausea; sweating; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); blurred vision; confusion; fainting; feeling of intoxication (feeling drunk); loss of coordination; mental or mood changes (eg, anxiety, depression); persistent trouble sleeping; severe tiredness or weakness; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent constipation; slow, shallow, or difficult breathing; slowed reflexes; sluggishness; slurred speech.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of buprenorphine and naloxone film:

Store buprenorphine and naloxone film at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store in the original package, away from heat, moisture, and light. Do not store in the bathroom. Do not use if the foil pouch has been damaged. Keep buprenorphine and naloxone film out of the reach of children and away from pets.

General information:

  • If you have any questions about buprenorphine and naloxone film, please talk with your doctor, pharmacist, or other health care provider.
  • Buprenorphine and naloxone film is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take buprenorphine and naloxone film or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about buprenorphine and naloxone film. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to buprenorphine and naloxone film. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using buprenorphine and naloxone film.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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