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Important Safety Information (ISI)

SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) is indicated for the treatment of opioid dependence.

It is extremely dangerous to take benzodiazepines or other depressants while taking SUBOXONE. A serious overdose and death may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as SUBOXONE.

SUBOXONE has potential for abuse and produces dependence of the opioid type, with a milder withdrawal syndrome than full agonists.

Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.

Allergic reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients taking buprenorphine.

There are no adequate and well-controlled studies of SUBOXONE (a Category C medication) in pregnancy.

Caution should be exercised when driving cars or operating machinery.

Always store buprenorphine-containing medications safely and out of the reach and sight of children. Destroy any unused medication appropriately.

The most commonly reported adverse events with SUBOXONE include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%). Please see full Prescribing Information for a complete list.

To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full US Prescribing Information for SUBOXONE.

I have read and understood the Important Safety Information.

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Talking with your doctor

An experienced doctor who is certified to treat opioid dependence will understand what you're going through. You might begin the conversation by telling your doctor how you've been feeling lately. Explain that you're concerned about your use of opioids and think you may have become dependent.

It's important that you are open and honest so your doctor can give you the best care. Be specific. Tell your doctor:

  • When you began misusing opioids, what you take, how much, and how often
  • If you got prescriptions from several doctors
  • If you crushed the tablets to take them in another form, such as snorting or injecting
  • If you've tried to stop using opioids and felt ill (you may have experienced withdrawal symptoms)
  • If you have found yourself using illicit drugs, including heroin
  • Anything else that might help your doctor understand what you've been experiencing

Get all of your questions answered

Create a list of questions to ask the doctor, and bring them along so you don't forget anything. You might be wondering:

  • Do I need treatment?
  • Can treatment help me?
  • Will I experience withdrawal?
  • How long does treatment typically last?
  • How will counseling help me?
  • What is my role in treatment? What are my responsibilities?

Questions your doctor may ask you

In order to understand the exact nature of your medical condition and recommend the best treatment, your doctor will have questions. Here are some you might hear:

  • Do you still have a medical reason to use prescription pain medication, such as a need for pain relief?
  • Do you take the medicine the way it was prescribed—the right number of tablets and at the right times during the day?
  • Have you ever used anyone else's prescription?
  • Have you ever sought pain medicine from several doctors at the same time?
  • Have you ever felt the need to cut down on your use of prescription opioid pain medication?
  • Have you ever given up activities to use prescription opioid pain medications?
  • Are you spending more time on activities to get prescription opioid pain medications?
  • Do you feel sick if you can't get enough drugs, and only feel normal when you do get them?
  • Do you use prescription opioid pain medication despite negative consequences?
  • Do you use any illicit drugs (eg, heroin)?

Feel free to speak frankly and honestly. Remember, what you tell your doctor is private and will not be shared without your explicit permission.

Remember, opioid dependence is a serious, long-term medical condition that needs care as much as any other chronic disease. That's why talking with your doctor is so important.

Print the Guide

Still looking for the right doctor? Let us help you make your first appointment with a doctor certified to treat opioid dependence in the privacy of his or her office: call 866-973-HERE (4373).

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SUBOXONE (buprenorphine HCl/naloxone HCl dihydrate) CIII sublingual tablets

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This site is sponsored by Reckitt Benckiser Pharmaceuticals Inc. and intended for residents of the United States.
SUBOXONE® and Here to Help® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.
This site is provided for educational and informational purposes only and is not intended
as a substitute for direct consultation with a qualified mental health professional.
Patient quotes are hypothetical.
© 2009 Reckitt Benckiser Pharmaceuticals Inc.

Important Safety Information (ISI)

SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) is indicated for the treatment of opioid dependence.

It is extremely dangerous to take benzodiazepines or other depressants while taking SUBOXONE. A serious overdose and death may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as SUBOXONE.

SUBOXONE has potential for abuse and produces dependence of the opioid type, with a milder withdrawal syndrome than full agonists.

Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.

Allergic reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients taking buprenorphine.

There are no adequate and well-controlled studies of SUBOXONE (a Category C medication) in pregnancy.

Caution should be exercised when driving cars or operating machinery.

Always store buprenorphine-containing medications safely and out of the reach and sight of children. Destroy any unused medication appropriately.

The most commonly reported adverse events with SUBOXONE include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%). Please see full Prescribing Information for a complete list.

To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full US Prescribing Information for SUBOXONE.