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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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What treatment is like

Your loved one's treatment, day by day, is likely to include:

  • Working with a treatment team, including a counselor
  • Keeping withdrawal symptoms and cravings to a minimum with his or her doctor's help
  • Learning to recognize triggers and prevent relapse with his or her counselor's help
  • Working to create balance in his or her life, including your loved one's thoughts, feelings, behavior, relationships, and physical health
  • Reconnecting with the important people in his or her life
  • Focusing on the things your loved one really cares about in life

Your loved one can talk with a doctor about treatment. Find a doctor near your loved one who is certified to treat opioid dependence in the privacy of his or her office.

Why counseling is a critical part of your loved one's treatment

While SUBOXONE works on the physical aspects of the disease, your family member or friend can begin to make the behavior and lifestyle changes that will help him or her stay focused on treatment—and start feeling and doing better.

Counseling can help your loved one learn to manage triggers and prevent relapse. Your loved one's treatment team and support network—which includes you!—can encourage and support his or her efforts to:

  • Get through each stage of treatment
  • Get involved with support groups or 12-step programs if appropriate
  • Learn how to identify high-risk situations that may trigger relapse and have coping mechanisms in place
  • Create positive behavior
  • Make meaningful lifestyle changes
  • Share the benefits of his or her experience with others

How have others coped? Hear real-life stories

Rebuilding your life

Being a caregiver of an opioid-dependent person can take its toll. Helping someone cope with a serious, potentially life-threatening illness can be stressful and difficult. Caregivers too can benefit from counseling to deal with the consequences of a loved one's misuse. You might also want to look into a support group for people who are helping someone in a similar situation.

Helping your loved one stay in treatment

Stay involved. If appropriate, offer to help your family member or friend keep up with his or her appointments and treatment regimen. Once your loved one's withdrawal symptoms and any cravings have subsided or been greatly reduced, doctor appointments may drop to once a week; or, if treatment is going very well, less frequently. Your loved one's doctor may continue to adjust the dose of SUBOXONE if needed.

Your loved one can stay in treatment for as long as necessary, depending on what he or she, the doctor, and other members of your loved one's healthcare team decide is best.

Support can help. Tell your loved one about Here to Help!

Find help here

Your loved one can get exclusive access to a Care Coach ready to support and encourage him or her along the way. Tell your 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.

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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.