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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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About the Here to Help Program

Some essential questions are answered below.

Q.
What is the Here to Help Program?

A.

Once you're in SUBOXONE treatment for opioid dependence, the Here to Help Program gives you exclusive access to powerful tools and resources that can help you set new goals and stay motivated as you work to get your life back on track.

The Here to Help Program gives you:

  • Support during your SUBOXONE treatment for opioid dependence
  • Telephone access to a personal Care Coach ready to offer guidance and encouragement
  • 24/7 online access to tools and information
  • Supportive e-mails to inspire you
  • Help finding the right counseling options
  • Links to peer support and educational resources

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Q.
How do I register?

A.

It's easy. Register at www.HereToHelpProgram.com, or call 866-973-HERE (4373). Then be sure to visit daily to download motivational tools, find answers to your questions, and get the support you need as you follow your treatment plan.

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Q.
How is this program different?

A.

Treatment and support work best together. So the Here to Help Program gives you the extra support you might need to manage your treatment—including useful tools and resources, your own personal Care Coach, and help finding a counseling option that's right for you.

We understand it's not easy to stand up and face the challenge of overcoming opioid dependence. But you've already done the hardest part—getting started. Over the next days, weeks, and months, we'll be here for you as you work to reach your goals.

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Q.
What's a Care Coach?

A.

Your Here to Help Care Coach is a trained professional who's just a phone call away. He or she can help you find a physician, counselor, or other resources that can help you manage your recovery day by day.

Plus, your Care Coach can answer questions, or direct you to someone who can. Call 866-973-HERE (4373) to tap into this valuable resource.

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Q.
What's the Everyday Success Planner?

A.

If you haven't tried it yet, the Here to Help Everyday Success Planner can help you organize questions and concerns to discuss with your counselor. It's also a great way track your progress between appointments. To use the Everyday Success Planner, simply log on to the Tools section of HereToHelpProgram.com using your username and password.

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Q.
What other kinds of support are available?

A.

When it's time to explore your counseling options, your Care Coach can help. Call 866-973-HERE (4373) for assistance and advice.

There's also a lot you can do right here.

The Here to Help Program gives you support during your SUBOXONE treatment for opioid dependence, including full access to this website, www.HereToHelpProgram.com. The website gives members 24/7 access to information and resources, along with useful tools and tips on ways to get the most from your treatment, including:

  • Helpful Tools: Find motivation, set new goals, and plan for success
  • Treatment information: Know what to expect from your medication every step of the way
  • Community connections: Link to other people who've been there; hear inspiring real-life stories
  • Counseling Support: Find a counseling option that works for you: private, online, or group
  • Help Living Well: Learn how to create more balance in your life, physically and emotionally
  • Learning: Be informed

Here to Help brings you crucial support as you follow your treatment plan and get your life back on track.

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Q.
What happens if I want to change doctors?

A.

If you want assistance finding another doctor, your Care Coach may be able to help you find one in your area. Also, be sure to keep your Care Coach in the loop on any changes to your care.

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

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© 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.