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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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How to ask for help

Opioid dependence is a complex condition, and you should expect to ask for advice and guidance many times along the way. Remember, when you ask for help, you take a step toward solving the problems you need to solve—and that can make you feel stronger and more in control.

There are always places to look for help. Try this approach:

1. Make a list of positive options

Make a list of all of your positive options. Include people who may be able to help you, such as family members and friends, along with the kinds of help they might be able to provide. (Steer clear of friends who are actively using drugs.) Be sure to include the members of your treatment team, especially your doctor and counselor. You may also want to add community organizations and support groups. Order the list by putting those you think may be most effective first.

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2. Refine your list

Think carefully about your options. List any issues that need to be resolved before an individual might be willing to help. Ask yourself who can help you now, and who might help you farther down the road, once you've demonstrated your commitment to treatment and shown some success. (Don't cross anyone off—just recognize that some people may take a little more time.)

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3. Take steps to resolve any issues you can

Sometimes friends or family members may have been hurt by your past behavior. These people may feel that, by offering help, they could be helping you continue your dependence. They may also be resentful or angry, or even afraid of behavior they don't understand.

Don't give up on them. Chances are, these friends and family members may turn out to be your strongest sources of support—though some may want you to demonstrate your commitment to treatment first.

Don't expect it to happen overnight. Apologizing, if you think you've been out of line, can be a good place to start. Educating loved ones about opioid dependence may help them understand: they may not know how opioids can affect the brain and change a dependent person's behavior. Friends and family members also need to believe that you've made a commitment to treatment. If issues still stand in your way, keep looking for the help you need elsewhere—but stay positive, and keep in touch with these loved ones as you continue to make progress.

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4. Ask for the help you need

Don't wait for help—you should be able to rely on your doctor, your counselor, and any support groups you wish to join right away. If there are still issues to be resolved with family members and friends, be patient. Let them know that you've made a commitment to treatment, and would like their support. Be clear about your treatment goals, and the kinds of help you need. Remember, most people like to be needed, and are often quite willing to help—just as you would be willing to help them. When the time is right, ask.

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5. Make a commitment to keep asking

You may not always find the help you need in the first place you look. The good news is, you can ask as many people, organizations, and groups as you like, until you find the help you need. Make a commitment to yourself that you'll keep asking.

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Where to find help:

Your doctor
Your counselor
Your Care Coach
Family members and friends
Self-help, 12-step, and support groups
People who've "been there"
Your community
Here to Help™

Your doctor

You can rely on your doctor not only for the help you need, but as a source of information to point you toward other places to find support. If you aren't in treatment yet, call 866-973-HERE (4373) and we'll help you set up an appointment with a doctor who is certified to treat opioid dependence in the privacy of his or her office.

Your counselor

Whether you're in one-on-one counseling or group therapy, your counselor can help you as you move through your treatment, as well as when you feel yourself close to relapse. Like your doctor, your counselor is also a source of information who can point you toward other places to find support. And, if you're in group therapy (also available online), you can ask the other members of your group for their ideas—and even their support.

Your Care Coach

Your Care Coach can provide you with information and support that can help you make better-informed decisions about your treatment, and also help you find clinical or medical professionals. (Your Care Coach is not a substitute for professional care like counseling or therapy. Your Care Coach will NOT be able to provide you with any clinical or medical advice; just support and information.) If you're already in treatment, join the Here to Help Program for exclusive access to a personal Care Coach ready to offer guidance and encouragement. Call 866-973-HERE (4373) and we'll connect you with your own personalized Care Coach.

Family members and friends

Family members or friends you trust and know well can be excellent sources of support. Let them know how committed you are to making the changes you need to make—and be specific about the help you'd like. Let them know that you understand that support is a two-way street, and that you'll be there to help them when they need it, too. If you're out of touch, remember that renewing old contacts can be rewarding. Chances are, friends and loved ones will be glad to hear from you.

Self-help, 12-step, and support groups

Based on the idea that people who suffer from a similar problem will understand one another and can help, 12-step programs, such as Narcotics Anonymous, bring people together to share experiences at regular meetings. People who are in recovery can help guide others out of addiction through a structured 12-step program. Many people have used 12-step programs to achieve drug-free lives. You should know, though, that peer support groups can vary in their acceptance of medication-assisted abstinence. For this reason, if you are considering going to a 12-step meeting, you may want to talk to your doctor first to find out if that group welcomes SUBOXONE patients.

Narcotics Anonymous: na.org (818-773-9999)
Alcoholics Anonymous: aa.org (212-870-3400)

Other support groups may be available through community services, faith-based organizations, and elsewhere. There are also reputable peer support groups available online. 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. Seek out an online option that monitors the information that is being shared to ensure that nothing is misrepresented.

People who've "been there"

People who are further along in treatment are often eager to share the missteps they've made—and the secrets of their success. Self-help, 12-step, and support groups are good places to meet people who have gotten their opioid dependence under control and are working to get their lives back on track.

Your community

Community groups of all kinds, including religious and civic organizations, social services, and fraternal orders, can be good sources of help. Ask your doctor and counselor for advice, or call your local or state government to see what organizations are actively offering services and support in your area. Remember, part of your treatment is lifestyle change. Anything from volunteering to paint your church basement to helping out with a local event can help you get out of yourself, away from old habits, and involved.

Here to Help

If you and your doctor decide treatment with SUBOXONE is right for you, join the Here to Help Program and get support through every phase of your treatment—including exclusive access to a personal Care Coach, there to offer guidance and encouragement. You'll also get online tools, counseling options, and resources to help you stay motivated as you begin to get your life back on track.

When you get to where you're going, remember how you got there

One day soon you may be in a position to help others who are on the road to treatment success. It's a good feeling—and the act of helping someone else can help to make your own commitment to treatment stronger. Ask your doctor, counselor, group, or community organization how you can help.

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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.