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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.
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When you're in treatment for opioid dependence, having the support of your friends and family can make an enormous difference. A trusted friend or family member can give you valuable perspective on how well you're doing, and offer constructive advice, companionship, and encouragement along the way. Often, all you need to do to get that support is to ask for it.
The same is true if you want to offer your own support, or simply talk with someone you care about so you can understand what he or she is going through: it starts with a conversation.
If you're in treatment or beginning treatment and want your friend or your loved one's support, let him or her know.
If your friend or loved one is in treatment or beginning treatment and you want to help, find out how.
Opioid misuse can affect your family, and may put a burden on your relationships. But getting treatment is a positive thing to do. And so is letting someone you care about know you've made a commitment to doing what you need to do to deal with your opioid dependence.
How do you start? Tell your friend or loved one you want to have a talk about where you are now, where you want to be, and how you plan to get there: your treatment.
Let us help you make your first appointment: call 866-973-HERE (4373)
We're Here to Help you through every stage of your treatment. Enroll in the Here to Help™ Program to get the most out of your SUBOXONE treatment. You'll have exclusive access to a Care Coach ready to support and encourage you along the way. You'll also get online tools, counseling options, and e-mails to help you stay motivated as you work to get your life back on track.
Drug misuse can affect a family, and may put a burden on relationships. But getting treatment is a positive thing to do: it means the person you care about has made a commitment to doing what needs to be done to get his or her life back on track.
How do you start? Tell your friend or loved one you want to have a talk about their struggle with opioid dependence—and to get the help he or she needs.
Let your friend or loved one know to call 866-973-HERE (4373) for help setting up a first appointment.
Find help here. The person you care about can get exclusive access to a Care Coach ready to support and encourage him or her along the way. Tell your friend or loved one about the online tools, counseling options, and e-mails that can help him or her stay motivated—all part of the Here to Help Program.
