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Important Safety Information

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

It is extremely dangerous to self-administer non-prescribed 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 sweating (14%, placebo 10%). 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.

I have read and understood the Important Safety Information.

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Treatment Options and Success

Some essential questions are answered below.

Q.

A.

The goal of all treatments for opioid dependence is to enable individuals to manage their disease and gain control of their dependence. Each person's case is different, and the doctor who treats your dependence should work with you to create a treatment plan that is right for you.

Q.

A.

According to the National Institute on Drug Abuse and the Center for Substance Abuse Treatment, substance dependence treatment is typically more effective when:

  • You remain in treatment for an adequate period of time
  • You engage in counseling and other behavioral therapies—like people with diabetes or heart disease, people in treatment for drug addiction will need to change behavior to adopt a more healthful lifestyle
  • You find a counselor or therapist with whom you can develop a strong therapeutic relationship
  • You engage in services that help you take care of multiple needs. For instance, if you have another medical or psychological condition, you receive treatment for that as well. It could also mean that you have services that help you with employment or housing if needed—things like that
  • Your services change depending on how you are doing; for instance, when you have been doing well for some time, you might have services that just check in with you from time to time; when you are having more difficulty, you have services that are more frequent and intense, including hospitalization if needed
  • Your progress is objectively monitored by your treatment providers, through the use of urine drug screens and check-ups
  • You and your family understand what it means that substance dependence is a "chronic illness" and not something that just goes away after a short treatment
  • Your family is involved in your treatment
  • Your treatment providers work closely with each other, communicating clearly and coordinating their efforts
Q.

A.

According to the National Institute on Drug Abuse and the Center for Substance Abuse Treatment, substance dependence treatment is typically less effective when:

  • You use other substances
  • You end treatment too soon
  • There is other substance use in your home
  • You have family problems that aren't being addressed
  • You have other medical or psychological issues that aren't being addressed
  • Your work conflicts with treatment
  • Your treatment providers don't communicate with each other and/or give you conflicting information.
Q.

A.

Treatment of chronic diseases involves changing deeply imbedded behaviors, and relapse does not mean treatment failure. The chronic nature of the disease means that relapsing to drug use can occur. Relapse indicates the need for treatment to be reinstated or adjusted to a more intensive level of care until the person is again stable and drug-free.

Science has taught us that stress, cues linked to the drug experience (eg, people, places, things, mood), and exposure to drugs, are the most common triggers for relapse, so strategies need to be developed to help minimize or avoid these triggers. Counseling and group therapy or self-help groups are strongly recommended to help develop these strategies.

Q.

A.

Counseling or psychosocial therapy can be very helpful to almost anyone who is dependent on opioids. There are many types of counseling, including private therapy with a psychologist or psychiatrist and group counseling sessions.

  • Individual, or one-on-one counseling
    This is generally considered the best setting for addressing confidential issues. Private sessions with a psychiatrist, psychologist, or certified mental health counselor are recommended for patients being treated for depression, anxiety, or other mental health conditions that may be contributing to their opioid use.
  • Group therapy
    Many patients find group therapy to be particularly effective for treatment of opioid dependence because it provides a support network that they would otherwise lack. Groups are available through many support services, including drug and alcohol counseling centers, mental health centers, faith-based groups, and on-line services. Benefits of group therapy include:
  • Peer support and acceptance
  • Real-world examples of people experiencing recovery
  • Positive feedback to help improve patients' self-image
  • Family-like environment
  • A recent review of research indicates that a major predictor of whether someone remained abstinent after the first year of treatment was their level of participation in a self-help group.
  • Therapy groups are offered online as well as in person. Here to Help offers a link to eGetgoing, which provides online group therapy.
  • It is a good idea to let your doctor know if you are participating in a group because:
  • Your doctor should know about anything that potentially affects your treatment
  • If you are participating in an online support group that is a chat room, your doctor may want to confirm that it is reputable (some chat rooms are better than others as far as the quality of information and advice offered)
  • If your experiences with a particular in-person or online support group are positive, your doctor may want to recommend it to future patients
Q.

A.

Yes. For many, 12-step programs can be beneficial. They are very popular and most are modeled on Alcoholics Anonymous®. The idea is that people who suffer from a similar problem understand and can help one another. By coming together to share experiences at regular meetings, people who are in recovery can try and help guide others out of addiction through a structured 12-step program. Many people have used 12-step programs to achieve drug-free lives.

Two helpful websites are Narcotics Anonymous at na.org
(818-773-9999) and Alcoholic Anonymous at aa.org.

Q.

A.

Deciding whether to tell someone else about your disease and treatment is an individual decision. Sometimes, talking to other people can be helpful, since people who know about your treatment may be able to provide support when you need it. If you decide to tell someone about your efforts to gain control over your dependence, here are some tips:

  • Think about what you want to say beforehand
  • Explain your own situation—what your disease is, and what you are doing to manage it
  • Tell the person how long you've been in treatment and that you are trying to avoid triggers
  • Explain that because opioid dependence is a long-term brain disease, you may need months or even years of treatment
  • Give the person the name of your doctor, in case of emergency
SUBOXONE (buprenorphine HCl/naloxone HCl dihydrate) CIII sublingual tablets
Now Approved - SUBOXONE(R) (buprenorphine and naloxone) Sublingual Film CIII - Learn more about SUBOXONE Film

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Important Safety Information

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

SUBOXONE Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


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

It is extremely dangerous to self-administer non-prescribed 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 sweating (14%, placebo 10%). 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.


For information about SUBOXONE Film, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII)

For more about SUBOXONE Tablets, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) sublingual tablets (CIII)


* Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:

Patient preferred: Clinical trial participants preferred SUBOXONE Film over the SUBOXONE Tablet. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Based on your previous experience with SUBOXONE Tablets and your current experience with SUBOXONE Film, which product do you prefer?"

Dissolve time: The time required for both SUBOXONE Film and SUBOXONE Tablet dissolution is dependent on saliva quantity and is subject to individual variation, and dose and strength taken. Mean dissolution time for all doses tested (8 mg, 2 mg) was between 5 and 6.6 minutes for SUBOXONE Film and between 7 and 12.4 minutes for the SUBOXONE Tablet.

Taste: In a patient questionnaire, more than 71% of patients who have tried SUBOXONE Film rated the taste as neutral or better on a 10-point scale. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Please give this product (SUBOXONE Film) a score which shows how you would rate the flavor." 10=extremely pleasant and 1=extremely unpleasant.

Portability: Because each unit of SUBOXONE Film is individually packaged in a compact, child-resistant pouch, it's easy to carry with you. Remember to keep this medication out of the sight and reach of children, and take your prescription label along with you. If a child takes the medication, seek emergency care.

Child resistance: Meets the Consumer Product Safety Commission's standards for child resistance. During testing, 1 child out of 50 was able to open 2 or more pouches. After receiving instruction, the children's ability to open the pouches increased. It is important not to open the pouches in front of children.

Opioid-dependent patients who were on Buprenorphine-Medication Assisted Therapy (B-MAT) and engaged in the Here to Help program (completed 4 or more Care Coach calls) demonstrated improved adherence compared to control group for B-MAT. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.

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.
© 2010 Reckitt Benckiser Pharmaceuticals Inc.