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WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; and WITHDRAWAL SYNDROME IN NEWBORNS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially by a child, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant)

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare professional if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death

  • Get emergency help right away if you take too much Butrans (overdose)

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law

  • Accidental exposure, especially by a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch)

  • Tell your healthcare professional if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated

  • Tell your healthcare professional if you are breast-feeding, because Butrans passes into breast milk and may harm your baby

  • Tell your healthcare professional about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death

  • Using Butrans with alcohol or certain medicines, such as sleeping pills, medicines for anxiety, tranquilizers, or other opioids, may cause sleepiness, coma, breathing problems, or death. Do not use these types of medicines unless you are supervised by a healthcare professional

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma

  • Do not stop using Butrans without talking to your healthcare professional

  • Tell your healthcare professional if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death

  • Seek emergency medical help if you have trouble breathing or feel short of breath; if you have a fast heartbeat or chest pain; if you experience swelling of your face, tongue, or throat; or if you experience extreme drowsiness, become lightheaded when changing positions, or feel faint while using Butrans

  • Butrans may make seizures worse in people who experience seizures. Tell your healthcare professional if you have a history of seizures

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare professional if you have any of these symptoms and they are severe

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indications and Usage
What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant)

Important Safety Information
IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; and WITHDRAWAL SYNDROME IN NEWBORNS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially by a child, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare professional if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death

  • Get emergency help right away if you take too much Butrans (overdose)

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law

  • Accidental exposure, especially by a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch)

  • Tell your healthcare professional if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated

  • Tell your healthcare professional if you are breast-feeding, because Butrans passes into breast milk and may harm your baby

  • Tell your healthcare professional about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death

  • Using Butrans with alcohol or certain medicines, such as sleeping pills, medicines for anxiety, tranquilizers, or other opioids, may cause sleepiness, coma, breathing problems, or death. Do not use these types of medicines unless you are supervised by a healthcare professional

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma

  • Do not stop using Butrans without talking to your healthcare professional

  • Tell your healthcare professional if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death

  • Seek emergency medical help if you have trouble breathing or feel short of breath; if you have a fast heartbeat or chest pain; if you experience swelling of your face, tongue, or throat; or if you experience extreme drowsiness, become lightheaded when changing positions, or feel faint while using Butrans

  • Butrans may make seizures worse in people who experience seizures. Tell your healthcare professional if you have a history of seizures

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare professional if you have any of these symptoms and they are severe

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; and WITHDRAWAL SYNDROME IN NEWBORNS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially by a child, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant)

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare professional if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death

  • Get emergency help right away if you take too much Butrans (overdose)

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law

  • Accidental exposure, especially by a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch)

  • Tell your healthcare professional if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated

  • Tell your healthcare professional if you are breast-feeding, because Butrans passes into breast milk and may harm your baby

  • Tell your healthcare professional about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death

  • Using Butrans with alcohol or certain medicines, such as sleeping pills, medicines for anxiety, tranquilizers, or other opioids, may cause sleepiness, coma, breathing problems, or death. Do not use these types of medicines unless you are supervised by a healthcare professional

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma

  • Do not stop using Butrans without talking to your healthcare professional

  • Tell your healthcare professional if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death

  • Seek emergency medical help if you have trouble breathing or feel short of breath; if you have a fast heartbeat or chest pain; if you experience swelling of your face, tongue, or throat; or if you experience extreme drowsiness, become lightheaded when changing positions, or feel faint while using Butrans

  • Butrans may make seizures worse in people who experience seizures. Tell your healthcare professional if you have a history of seizures

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare professional if you have any of these symptoms and they are severe

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.