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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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What to expect from SUBOXONE®
(buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII)

SUBOXONE is an opioid with special characteristics

SUBOXONE is itself an opioid. But unlike opioid prescription painkillers and heroin, which are "full opioid agonists," SUBOXONE is a "partial opioid agonist." That means it attaches to the same receptors in the brain that the other opioids attach to, but it doesn't have the same maximal effect. Because SUBOXONE binds tightly to the body's opioid receptors, it can block, depending on the dose, the effects of other opioids.

When medication-assisted treatment is combined with counseling, the likelihood of success is increased.

People who want to stop taking opioids can find it very difficult. Their need to satisfy cravings or avoid withdrawal can be so intense that they feel desperate and overwhelmed. At the right dose, and with psychosocial intervention (eg, counseling) SUBOXONE can suppress opioid withdrawal symptoms and suppress cravings to help you continue treatment and avoid illicit opioid use.

How you take SUBOXONE

SUBOXONE is a small orange tablet that is placed under the tongue. As it dissolves, it is absorbed into your bloodstream. SUBOXONE should not be chewed or swallowed. Take SUBOXONE only as directed by a specially certified physician.

SUBOXONE can begin to help you after the first dose

SUBOXONE therapy usually begins in a doctor's office. You need to be in a moderate state of withdrawal for SUBOXONE to work properly. If you are not already experiencing withdrawal symptoms when you use SUBOXONE at this stage, your therapy has the potential to cause withdrawal symptoms.

A short time after your first dose—about 30 to 60 minutes—your doctor should check to see how well SUBOXONE is controlling your withdrawal symptoms. If necessary, the doctor may adjust your dose.

In the beginning, the doctor will probably want to check your progress every day or so. Then, when your doctor has determined a dose that is right for you, you can both decide when you need to come in again. Your doctor may have already given you a prescription at this point, so you can begin to take SUBOXONE at home. He or she should also have talked to you about initiating counseling as part of your treatment.

Why counseling is important

When medication-assisted treatment is combined with counseling, the likelihood of success is increased. This is why counseling was always a part of therapy when the effectiveness of SUBOXONE was studied in clinical trials.

With counseling, you can learn how to recognize events that can trigger the use of opioids. You can also learn ways to cope with events or social situations associated with past drug use, and learn skills that can help you recognize triggers that can stimulate cravings, to prevent relapse as you rebuild your life.

Combining counseling with SUBOXONE

Opioid dependence causes long-term changes to the structure and function of the brain. While SUBOXONE is working on the physical aspects of the disease, you can begin to make changes in your behavior and lifestyle that will help keep you focused on your treatment goals.

Because opioid dependence is a chronic medical condition, relapse can happen—but your healthcare professionals can help you get back on track. Their goals are yours:

  • Get through all the stages of your SUBOXONE therapy
  • Learn how to identify high-risk situations that may trigger relapse and have coping mechanisms in place
  • Create positive behavior
  • Make meaningful lifestyle changes

See Support for more on counseling—including help finding a counselor near you.

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

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I kept thinking, I am really going to suffer. But before I knew it, I was following my treatment plan every day.

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.