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SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)

Frequently asked questions

Some essential questions about opioid dependence and its treatment with SUBOXONE Film are answered below.

How treatment can help

What is the goal of treatment?

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

What are opioids?

Opioids are drugs that work in the body the way opium does. Some, such as morphine, codeine, and the illegal drug heroin, are made directly from opium. Others, such as the painkillers oxycodone, hydrocodone, and fentanyl (better known by brand names OxyContin®, Vicodin®, Percocet® and Actiq®)* are semi-synthetic or synthetic but chemically similar to opium.

For people with severe pain, opioids are very effective medicines, and most patients treated for pain with opioids do not become dependent on them. For some people, however, opioid dependence is an unexpected side effect of proper pain treatment. The problem comes when someone is unable to stop using the drug after the pain passes, or when casual recreational use becomes dependence or addiction.

*All brand names above are the property of their respective owners. Vicodin is a registered trademark of Knoll Pharmaceuticals, now Abbott Laboratories. Percocet is a registered trademark of Endo Pharmaceuticals, Inc. Actiq is a registered trademark of Cephalon, Inc. OxyContin is a registered trademark of Purdue Frederick Company.

What is opioid dependence?

Dependence on opioids—opioid prescription pain medication or heroin—is a treatable medical condition caused by changes in the chemistry of the brain that occur as a result of the use of opioids. It has been defined as a long-term brain disease by both the World Health Organization and the National Institute on Drug Abuse.

Opioid dependence can begin with a simple prescription to treat serious pain or with the recreational drug use of prescription pain medications or heroin. Regardless of how a person becomes dependent, once dependence has developed it is considered a long-term medical condition that requires treatment.

What is opioid substance use disorder?

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5TM), a person who shows 2 or more of the following behaviors over a 12-month period may have a substance use disorder:

  • Needing to take more of the drug to get the same effect—or getting a lesser effect from the same amount of the drug*
  • Experiencing withdrawal symptoms when not using opioids, or taking other drugs to help relieve withdrawal symptoms
  • Taking larger amounts of opioids than planned, and for longer periods of time
  • Craving for opioids
  • Persistently wanting to quit, or trying unsuccessfully to quit
  • Spending a lot of time and effort to obtain, use, and recover from taking opioids
  • Giving up activities because of substance use
  • Continuing to use opioids in spite of negative consequences
  • Failing to fulfill major obligations
  • Recurrent use in hazardous situations
  • Continued use despite social or interpersonal problems

*This criterion does not apply to individuals taking opioids under appropriate medical supervision.

Source: American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders (Fifth ed.). Arlington, VA: American Psychiatric Publishing.

Why can't I just stop misusing opioids on my own?

The initial decision to take a drug, whether a prescribed medication or a "street" drug, would be considered under voluntary control. However, when someone develops a dependence on that substance, the person's ability to exert self-control can become seriously compromised. Brain imaging studies from drug-dependent individuals show physical changes in areas of the brain that are critical to judgment, decision-making, learning and memory, and behavior control. Scientists believe that these changes alter the way the brain works, and may help explain the compulsive and destructive behaviors of drug dependence.

Although, logically, a person may know that opioids are not essential for life, as long as those parts of the brain in charge of survival behavior still believe opioids are necessary, they may override "higher reasoning." Furthermore, to an opioid-dependent brain, not having enough opioids to satisfy cravings or suppress withdrawal is comparable to not having enough food to satisfy hunger.

The need to obtain opioids can become more important than that person's safety because opioid-dependence can impair the mechanism by which information from certain areas of the brain—namely, those involved with judgment and caution—is received. The brain responds by taking whatever steps are necessary to see that its opioid "hunger" is met, which usually means pursuing opioids with all the drive of a basic instinct.

Why is opioid dependence a long-term (chronic) condition?

The development of opioid dependence causes complex, long-term, changes in the structure and functioning of the brain. The significant changes to brain "circuitry" have led addiction, medical, and scientific experts to classify it as a disease that interferes with normal brain functioning.

Typically, the changes that cause opioid dependence will not correct themselves right away, even though the misuse of opioids has stopped. In fact, these changes can trigger cravings months and even years after someone has stopped using opioids. Consequently, managing opioid dependence is not simply a matter of eliminating drugs from the body.

How does opioid dependence compare with other long-term (chronic) conditions?

As a long-term medical condition, opioid dependence has some things in common with illnesses such as diabetes, asthma, or heart disease:

  • It can be successfully managed, but not "cured"
  • Both medication and changes in behavior can be helpful
  • It can sometimes run in families
  • People can have periods when they are symptom-free as well as periods when they are symptomatic

Sometimes, even those who have done everything they can to stop taking opioids might still experience overwhelming cravings or other symptoms that put them at risk for relapse. It is important to be open to the idea of continuing treatment.

What is the role of medicine in treatment?

Medicine is important for managing both the short- and long-term effects of opioid dependence. Over the short-term, medication can help to relieve the opioid cravings and withdrawal symptoms that occur when use of heroin or opioid pain medicine is discontinued. Medication can also be important over the long-term as it continues to help relieve opioid cravings.

The Center for Substance Abuse Treatment (CSAT) Clinical Guidelines for the Use of Buprenorphine recommend that patients stay on medication after they have "detoxed" from their drug of misuse. This gives patients time to learn new skills that can help them cope with cravings and other triggers that might otherwise make them vulnerable to relapse.

What are some risk factors for becoming opioid dependent?

Most people who use opioids do not become opioid-dependent. This suggests that, while the reward circuit is responsible for opioids' addictive potential, opioid dependence most likely involves additional factors.

Exactly why some people, and not others, become dependent on opioids (or any addictive substance) is not totally understood. However, certain factors appear to increase the likelihood of dependence, including:

  • Genetic factors (scientists estimate that genetic factors account for between 40% to 60% of a person's vulnerability to dependence, including the effects of environment on gene expression and function)
  • Psychiatric disorders (for example, depression or bipolar disorder)
  • Stress (high stress seems to increase the desire to use drugs)
  • Properties of the drug itself (for example, how quickly it creates a "high," how long the effects of the drug last)
  • Substance abuse, which can lead to dependence, is often highly influenced by societal norms and peer pressure
  • Having a risk-taking or novelty-seeking personality
What is SUBOXONE Film?

In 2010, SUBOXONE Film was approved by the FDA for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and behavioral therapy. The range of dose strengths available allows your doctor to prescribe the precise dose you need using only 1 or 2 films, helping to minimize the risk of overmedication or breakthrough withdrawal symptoms. SUBOXONE Film comes in 2 mg, 4 mg, 8 mg, and 12 mg unit-dose packaging.

Only SUBOXONE Film comes with the Here to Help® Program, a self-guided, online support program to help you stay motivated, keep up with your treatment, and make important changes that could support your ongoing recovery.

SUBOXONE was the first opioid dependence treatment that could be prescribed in a doctor's office and taken at home. As part of a treatment plan that includes counseling and support, medication-assisted therapy has helped millions of people take steps to rebuild their lives.

You should know: Do NOT use SUBOXONE Film to manage pain. Use of SUBOXONE by people who are not opioid dependent—even at the lowest available doses—has resulted in respiratory depression and death.

How might treatment that includes SUBOXONE Film help?

A number of clinical trials have established that treatment with buprenorphine, the main ingredient in SUBOXONE Film, along with counseling and behavioral therapy, helps patients stay in treatment by:

  • Suppressing withdrawal symptoms
  • Reducing cravings

Staying in treatment may help reduce illicit opioid use.

Does return to drug misuse (relapse) mean treatment has failed?

Relapse does not have to mean treatment failure. The chronic nature of opioid dependence means that relapsing to drug use can occur. Relapse is a sign that treatment should be restarted and adjusted until the person is stable again.

Stress and cues linked to the drug experience such as people, places, moods, and exposure to drugs, are the most common triggers for relapse. Most patients need to develop strategies to minimize or avoid these triggers. Counseling and behavioral therapy can help you develop these strategies.

Getting ready for treatment

How do I get a prescription for SUBOXONE Film?

Only doctors with specific training and a special license can prescribe SUBOXONE Film. And while your primary care doctor may not be able to treat your condition with SUBOXONE Film, nearly 13,000 other actively treating physicians can.

Call your insurance plan to see which doctors are in your plan and whether your plan covers SUBOXONE Film (most plans do). You should also ask the doctor you choose about how they handle insurance.

A qualified, licensed doctor will understand what you're going through. Print out a SUBOXONE Film Doctor discussion guide and bring it to your appointment. Have it with you during your appointment (some doctors start with a telephone conversation). Choose the guide that fits your situation:

Remember to jot down your own questions and bring them along. Feel free to speak frankly and honestly. Opioid dependence is a serious medical condition that needs care as much as any other chronic disease. That's why talking with your doctor—and getting the most you can out of your treatment—is so important.

You should know: Tell your doctor about any central nervous system depressants (such as a benzodiazepine) you are taking. Your doctor may want to reduce the dose of your depressant, your dose of SUBOXONE Film, or both.

How do the ingredients in SUBOXONE Film work?

Watch this video for an overview.

When an opioid (such as oxycodone, hydrocodone, morphine, methadone, or heroin) binds to receptors in the central nervous system, it can cause feelings of euphoria—a "high." If you're opioid dependent, it can also cause painful withdrawal symptoms when the opioid leaves the receptors.

Buprenorphine—the active ingredient in SUBOXONE Film—binds to those same receptors. Because buprenorphine is a partial opioid agonist, it produces less than the maximum possible effect, while at the same time blocking other opioids. That's why, when taken as prescribed, SUBOXONE Film helps suppress withdrawal symptoms and reduce cravings.

Naloxone is added to help deter intravenous misuse. If SUBOXONE Film is dissolved and then injected, the naloxone can cause withdrawal symptoms in a person dependent on full opioid agonists. If SUBOXONE Film is taken as directed, the naloxone will not have this effect.

You should know: Long term use of SUBOXONE causes physical dependence. Never stop taking SUBOXONE Film without first talking with your doctor. If you abruptly stop treatment with SUBOXONE Film, or reduce the amount you take too quickly, you could experience withdrawal symptoms.

Am I just substituting one drug for another?

Medicine can be an important part of a plan to manage the short- and the long-term effects of opioid dependence. Typically, the changes that cause opioid dependence will not be corrected right away, even though the misuse of opioids has stopped. In fact, these changes can trigger cravings months and even years after a patient has stopped misusing opioids.

Using medication-assisted treatment for opioid dependence is much like using medication for other chronic illnesses, such as asthma or heart disease. SUBOXONE Film—along with a complete treatment plan that includes counseling and psychosocial support—can help patients stay in treatment by suppressing withdrawal symptoms and reducing cravings.

You should know: Be sure to let your doctor know if you are pregnant. Withdrawal symptoms have been reported in newborns whose mothers used buprenorphine, the main active ingredient in SUBOXONE Film, during pregnancy.

What if I'm afraid to tell my doctor everything about my opioid use?

It is important to communicate openly and honestly with your entire healthcare team (your doctor, nurse, and counselor) to optimize the success of your treatment for opioid dependence. They have been trained to understand opioid dependence and how to best treat this medical condition.

Be specific about when you started using opioids, what you took, how much you took, and how often you took it. If you obtained prescriptions from several doctors, let your doctor know so that your care is coordinated and understood. If you misused medications by crushing, snorting, injecting, or taking them in a way that is not prescribed, also let your doctor know.

If you have been using heroin as well as prescription pain medicine, or if you are also using other drugs, let your doctor know. Your doctor needs to know about ALL of the chemicals you've been using in order to determine what treatment is best for you. SUBOXONE Film is meant only for maintenance treatment of opioid dependence; other types of substance use should NOT be treated with SUBOXONE Film, and may require alternate therapy.

You should know: Do NOT use SUBOXONE Film to manage pain. Use of SUBOXONE by people who are not opioid dependent—even at the lowest available doses—has resulted in respiratory depression and death.

What is Induction?

Treatment begins with Induction. The goal of induction is to transition you from your current opioid (heroin, methadone, or an opioid prescription pain medicine) as rapidly as possible to the right dose of buprenorphine.

You MUST arrive for your induction already experiencing at least moderate opioid withdrawal symptoms. Ask your doctor for detailed instructions when you schedule your appointment. Being in this state is vital to having buprenorphine suppress your withdrawal symptoms.* The opioid you've been misusing needs to be free from the receptors in your brain so that the buprenorphine can bind to them.

Your doctor will give you your first dose of the buprenorphine, which can be adjusted if you are still not feeling relief. When you're ready to leave the office, the doctor may give you instructions and a prescription that will last until your next appointment, usually within the next few days. The doctor may also want to discuss counseling or behavioral therapy as part of your treatment plan.

You should know: Your doctor may conduct liver tests before and during your treatment with SUBOXONE Film, and investigate any suspected changes in your liver function.

*SUBOXONE Film is not indicated for induction. A buprenorphine-only medication is preferred.

How long does induction take?

At the time of induction, patients can begin to feel some relief within 20 minutes of the first dose, although the full effects take about an hour and a half (90 minutes), at which point your symptoms should be reassessed. Depending on the extent to which the first dose of buprenorphine suppressed your symptoms, your doctor may decide to give you additional doses.

Note: SUBOXONE Film is not indicated for induction. A buprenorphine-only medication is preferred.

Why do I need to be in moderate withdrawal when I start my treatment?

This point cannot be emphasized enough: If you were to begin buprenorphine treatment without being in moderate withdrawal, you may experience more severe withdrawal symptoms.

If you are in moderate withdrawal when you take your first dose, buprenorphine should make you feel like your withdrawal symptoms are subsiding, not getting worse. As the opioids from prescription pain medication or heroin leave the brain's opioid receptors, the buprenorphine binds to those receptors. Your withdrawal symptoms diminish as the receptors fill up with buprenorphine.

However, if you still have high levels of another opioid in your system, buprenorphine will compete with the other opioid molecules and knock them off the receptors. Buprenorphine then replaces those opioid molecules on the receptors, but because buprenorphine doesn't provide as much of an effect as a full opioid agonist, you may go into withdrawal and feel sick. This is called precipitated withdrawal.

It is really important that you tell your doctor about the last time you used an opioid (along with any other medication), including what you took, when you took it, and how much you had, so he or she can determine the timing of your first dose of buprenorphine.

You should know: Intense withdrawal symptoms are highly likely if:

  • Someone who is dependent on full opioid agonists, such as opioid prescription painkillers or heroin, injects the ingredients in SUBOXONE Film
  • Someone takes SUBOXONE Film under the tongue, but before the effects of other opioids have worn off
How do I know when I am taking the right dose?

It's important to let your doctor know about any withdrawal symptoms or cravings you experience, so you can work together to determine whether you might benefit from a change in your dose or from additional counseling services. Please see the Medication Guide for more information.

SUBOXONE Film comes in individually packaged 2 mg, 4 mg, 8 mg, and 12 mg doses.

What are the possible side effects?

Do not take SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Sublingual Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Sublingual Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Sublingual Film.

You should not drink alcohol while taking SUBOXONE Sublingual Film, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your doctor may monitor liver function before and during treatment.

SUBOXONE Sublingual Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Sublingual Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

Keep SUBOXONE Sublingual Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Sublingual Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Sublingual Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting SUBOXONE may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE Sublingual Film, tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant while taking SUBOXONE Sublingual Film, alert your doctor immediately and you should report it using the contact information provided below.*

Neonatal withdrawal has been reported following the use of buprenorphine by the mother during pregnancy.

Before taking SUBOXONE Sublingual Film, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. SUBOXONE can pass into your breast milk. You and your doctor should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Sublingual Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Sublingual Film affects you. Buprenorphine in SUBOXONE Sublingual Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE Sublingual Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

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

For more information about SUBOXONE Sublingual Film or SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII), please see full Prescribing Information and Medication Guide at www.SuboxoneREMS.com.

What happens if someone takes SUBOXONE Film at the same time as another opioid?

It depends on which was taken first. If someone who is taking SUBOXONE Film as prescribed takes another opioid, then, at the right dose, the buprenorphine in the SUBOXONE Film will help block the effect of the other opioid.

If someone who is actively using other opioids takes SUBOXONE Film, the SUBOXONE Film may cause sudden and severe ("precipitated") withdrawal. (See "Why do I need to be in withdrawal when I start my treatment?" for more information).

You should know: People who have taken buprenorphine have suffered serious breathing problems and death—especially when taking buprenorphine by injection, and in combination with benzodiazepines or other central nervous system depressants (including alcohol).

Can people become addicted to buprenorphine?

Yes. Buprenorphine—the active ingredient in SUBOXONE Film—is an opioid, and all opioids can cause dependence. But, unlike opioid prescription painkillers and heroin, which are "full opioid agonists," buprenorphine is a "partial opioid agonist." That means that the buprenorphine in SUBOXONE Film attaches to the same receptors in the brain that the other opioids attach to, but it provides only a partial effect.

You should know: Long-term use of SUBOXONE Film can cause physical dependence. Never stop taking SUBOXONE Film without first talking with your doctor. If you abruptly stop treatment with SUBOXONE Film, or reduce the amount you take too quickly, you could experience withdrawal symptoms.

How long will I stay on SUBOXONE Film?

The length of treatment can vary from patient to patient. It is up to you, your doctor, and your therapist or counselor to decide on the appropriate length of treatment.

Long-term treatment may give you and your physician the opportunity to make adjustments to thinking and behaviors that influence drug use. Medication-assisted treatment, along with counseling and support, may help you minimize the possibility of relapse and increase your chance of treatment success.

The role of treatment that includes SUBOXONE Film is to help you stay in treatment and reduce illicit opioid use by helping to suppress withdrawal symptoms and reduce cravings. It's important to remember that opioid dependence is considered a long-term, or chronic, illness, just like asthma or heart disease. The decision to be on medication-assisted treatment is often based on whether someone's symptoms (in this case, cravings and compulsive drug use) are likely to return if the medication is stopped, as well as whether the person in treatment is likely to resume misusing opioids.

Although short-term treatment may be an effective option for some, for others it may not allow enough time to address the psychological and behavioral aspects of their condition, or to reduce illicit opioid use. The chance of relapsing can be higher with short-term treatment. In general, suppressing withdrawal symptoms and reducing cravings for other opioids with SUBOXONE Film (for as long as necessary), together with counseling and behavioral therapy, can make treatment success more likely.

You should know: SUBOXONE Film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and support.

What is the Here to Help® Program?

The Here to Help® Program is a personal support program for people in treatment with SUBOXONE Film. Use the Here to Help® Program to take steps that could help support your recovery, including:

  • Seeing opioid dependence as the long-term (chronic) medical condition it is—and understand what that means to you
  • Realizing how opioid dependence may have affected you, and give you direction to plan and move forward
  • Addressing your individual needs in ways that could help you maintain momentum and make further progress
  • Learning skills that could help you make important changes and stay in treatment
  • Securely tracking what you accomplish, and share it with your treatment team
  • Getting answers to important questions—so you can take action guided by known factors for treatment success
  • Creating detailed, personalized action plans that fit your own unique situation so you can get through tough moments and stay on track
  • Learning, planning, and taking practical steps that could help you manage stress, handle difficult situations, think more positively, and keep making progress

Get started now.

Note: The Here to Help® Program is private, confidential, and secure. The Here to Help® Program can help you track your progress, but does not save your action plans or results. You can download them to your own computer or print them out to share with your doctor, counselor, or others who support your treatment. Only you can access your program, via the username and password you create.

What other kinds of support are available?

When you're ready to explore your counseling options, talk with your doctor or call 866-973-HERE (4373) for help finding counseling options. If you're a SUBOXONE Film patient, you can also take advantage of the Here to Help® Program and take steps that could help strengthen your recovery. Spend a few minutes each day, or set a specific time each week, for improving vital skills that could help you make important changes and stay in treatment. Use your personal Here to Help® Program Dashboard to track what you've accomplished securely, so you can share it with your treatment team.

Sign up for the Here to Help® Program—it's included with your prescription for SUBOXONE Film.

You should know: Your doctor is your best source of information about your treatment. The Here to Help® Program is not a substitute for professional counseling or behavioral therapy. Having support is not a guarantee that you will meet your treatment goals.

Note: The Here to Help® Program is private, confidential, and secure. The Here to Help® Program can help you track your progress, but does not save your action plans or results. You can download them to your own computer or print them out to share with your doctor, counselor, or others who support your treatment. Only you can access your program, via the username and password you create.

Managing your ongoing treatment

What happens during maintenance treatment?

During the maintenance phase of your treatment, the doctor will see you regularly to monitor your progress, adjust your dose of medication if necessary, and address any issues that may be affecting your treatment. You and your treatment team—including your doctor and your counselor or behavioral therapist—focus on making progress in managing your triggers and cravings, working to prevent relapse, and making behavioral changes to help keep you on course.

What are the keys to successful treatment?

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 opioid dependence 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
  • 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 supports your treatment efforts
  • Your treatment providers work closely with each other, communicating clearly and coordinating their efforts

The Here to Help® Program is designed to fit your personal needs, to build on what your doctor and counselor are already doing, and help you make your treatment as successful as you can.

You should know: Your doctor is your best source of information about your treatment. The Here to Help® Program is not a substitute for professional counseling or behavioral therapy. Having support is not a guarantee that you will meet your treatment goals.

What could make achieving success more difficult?

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
What are triggers?

In addition to functioning as a reward, dopamine is also the brain's way of ensuring that the experience itself will not be easily forgotten. Dopamine release activates the areas of the brain involved in memory formation to record details about the environment where the event occurred.

Which details the brain chooses to record can range from the obvious (where the incident occurred, who was there) to the obscure (a billboard passed on the way, the temperature outside). There is no way to know ahead of time what details the brain has stored. But whatever they were, when those circumstances are encountered in the future, they will trigger memories of the good feelings produced by dopamine, and, often, a desire to recreate that experience. The technical term for these memories is "conditioned associations," but most people familiar with opioid dependence refer to them as "triggers."

Please see full Product Information and Medication Guide for SUBOXONE Film

How should I take SUBOXONE Film?

Always take your medication exactly as prescribed by your doctor, and see the Medication Guide that accompanies your prescription for full instructions. Call your doctor's office with any questions.

Remember to keep your SUBOXONE Film in a secure place out of the sight and reach of children.

Watch the video to see how to take SUBOXONE Film.

If you have any questions, talk with your doctor.

SUBOXONE Film is an orange-colored, rectangular film with a white printed logo. Each film comes in unit-dose, child-resistant packaging. It comes in 2 mg, 4 mg, 8 mg, and 12 mg doses.

When you take SUBOXONE Film:

  1. To open your medication package, fold along the dotted line and tear downward at the slit. If you prefer, you can also use scissors to cut along the arrow.
  2. Before taking SUBOXONE Film, it's a good idea to drink some water to moisten your mouth. This should help the films dissolve more easily.
  3. Make sure your hands are dry. Hold SUBOXONE Film between two fingers by the outside edges of the film.
  4. Place the film under your tongue (close to the base either on the left or the right side of the center). The medication in SUBOXONE Film is absorbed into the bloodstream through blood vessels under your tongue.
  5. Keep the films in place until they are completely dissolved.
    • While SUBOXONE Film is dissolving, don't chew or swallow—less medication will be absorbed into your bloodstream and you may not get the amount of medicine you need.
    • Talking while the films are dissolving can interfere with how well the medication in SUBOXONE Film is absorbed. You may want to do something that doesn't involve talking, like reading a book or watching television, while waiting for SUBOXONE Film to dissolve. Let family and friends know that you won't be able to answer them or talk on the phone while your medication is dissolving.
  6. If you are directed to use 2 films at a time, place the second SUBOXONE Film under your tongue on the opposite side. Try to avoid having the films touch.
  7. If you are directed to use a third SUBOXONE Film, place it under your tongue on either side after the first 2 films have dissolved.
  8. Take your SUBOXONE Film in the same way each time to ensure consistency in drug absorption.

IMPORTANT:

Keep SUBOXONE Film in a secure place out of the sight and reach of children. Always store the pouches that contain your SUBOXONE Film in a cool, DRY place to protect your medication.

Do not stop taking SUBOXONE Film suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Ask your doctor how to stop using SUBOXONE Film the right way.

You should know: Always store SUBOXONE Film safely out of the sight and reach of children. Buprenorphine, the main ingredient in SUBOXONE Film, can cause serious breathing problems in children that could result in death.

Can I take too much SUBOXONE Film?

Yes. It is important to take SUBOXONE Film exactly as prescribed by your doctor. Patients who feel that they need a higher dose than prescribed should talk with their doctor about their concern, and any dosing adjustments should be made with a doctor's guidance.

You should know: SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film.

What's the best time to take SUBOXONE Film?

SUBOXONE Film has once-daily dosing. There is no clinical evidence indicating the best time of day to take SUBOXONE Film, but taking your prescribed dose at the same time every day is recommended.

How should I dispose of unused SUBOXONE Film?

Dispose of unopened SUBOXONE Films as soon as you no longer need them:

  1. Remove the SUBOXONE Film from its foil pouch.
  2. Drop the SUBOXONE Film into the toilet.
  3. Repeat steps 1 and 2 for each SUBOXONE Film. Flush the toilet after all unneeded films have been put into the toilet.

Do not flush foil pouches or cartons down the toilet

You should know: Always store SUBOXONE Film safely out of the sight and reach of children. Buprenorphine, the main ingredient in SUBOXONE Film, can cause serious breathing problems in children that could result in death. Children who accidentally take SUBOXONE Film will need emergency medical care.

Should I contact my doctor if I have side effects?

Contact your doctor if:

  • You feel faint, dizzy, confused, or have any other unusual symptoms, or if your breathing becomes much slower than normal. These can be signs of taking too much SUBOXONE Film or of other serious problems
  • You experience an allergic reaction. Symptoms of a bad allergic reaction include difficulty breathing, hives, swelling of your face, asthma (wheezing), or shock (loss of blood pressure and consciousness)
  • You suspect liver problems due to any of these symptoms:
    • Your skin or the white part of your eyes turns yellow (jaundice)
    • Your urine turns dark
    • Your bowel movements (stools) turn light in color
    • You don't feel like eating much food for several days or longer
    • You feel sick to your stomach (nauseated)
    • You have lower-stomach pain
  • Be aware that SUBOXONE Film can change the size of your pupils and cause differences in levels of consciousness. This may affect:
    • A doctor's evaluation of you if you've experienced a head injury
    • Safe driving

You should also note that pupil size is one method law enforcement officers use to evaluate drivers when they suspect intoxication.

You should know: Use caution while taking SUBOXONE Film and driving or operating machinery.

Why does my doctor insist that I have a urine drug screen during my visit?

Urine drug screening is considered good medical practice while patients are in treatment with SUBOXONE Film. Urine drug screening has been identified by the National Institute on Drug Abuse as one of the factors that helps patients to be successful in treatment.

You should know: As with other opioids, buprenorphine can be abused. It's essential that your doctor monitor your use of SUBOXONE Film to help you achieve and maintain stability. You should also expect to make regular follow-up visits, especially if your doctor prescribes multiple refills.

What are my counseling and behavioral therapy options?

Counseling or behavioral therapy can be very helpful to people who are 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 and behavioral therapy 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.

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 online services. The potential 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

Therapy groups are offered online as well as in person.

Should you decide to participate in group therapy, it is a good idea to let your doctor know 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
Can 12-step programs be helpful?

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 opioid dependence through a structured 12-step program. Many people have used 12-step programs to support their recovery.

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

Should I tell people I'm in treatment?

Deciding whether to tell someone else about your condition and treatment is an individual decision. Sometimes, talking to other people can be helpful because 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 medical condition 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, or chronic, condition, you may need months or even years of treatment
  • Give the person the name of your doctor, in case of emergency
How is the Here to Help® Program different?

The Here to Help® Program is an online personal support program, designed to work as part of a complete treatment plan that includes counseling and SUBOXONE Film. Its unique, interactive approach—built around known factors known to contribute to treatment success—can help you:

  • Focus on the issues that are most important to you and your treatment right now, today
  • Recognize issues that might put your treatment at risk, so you can make plans to interrupt early signs of trouble
  • Improve vital skills that could make your recovery stronger: learn, plan, and take practical steps that could help you manage stress, handle difficult situations, think more positively, and keep making progress

The Here to Help® Program is only for people in treatment with SUBOXONE Film. Get started now.

Note: The Here to Help® Program is private, confidential, and secure. Only you can access your program, via the username and password you create.

How do I sign up for the Here to Help® Program?

If you're a SUBOXONE Film patient, sign up now and get full access to guided support that can help you:

  • See opioid dependence as the long-term (chronic) medical condition it is—and understand what that means to you
  • Realize how opioid dependence may have affected you, and give you direction to plan and move forward
  • Address your individual needs in ways that could help you maintain momentum and make further progress
  • Learn skills that could help you make important changes and stay in treatment
  • Securely track what you accomplish, and share it with your treatment team

Get started now.

Note: The Here to Help® Program is private, confidential, and secure. The Here to Help® Program can help you track your progress, but does not save your action plans or results. You can download them to your own computer or print them out to share with your doctor, counselor, or others who support your treatment. Only you can access your program, via the username and password you create.

What happens if I stop taking SUBOXONE Film?

Do not stop taking SUBOXONE suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using SUBOXONE.

What if I've relapsed?

Get in touch with your doctor right away: you may be experiencing the early signs of withdrawal. Your counselor may also be able to help.

The most important thing is to seek treatment. If you have a setback, find essential guidance that could help you get back into treatment and assist your recovery at the Here to Help® Program.

What is Medical Taper?

The length of treatment can vary from patient to patient. It is up to you, your doctor, and your therapist or counselor to decide on the appropriate length of treatment. If you and your treatment team agree that the time is right, your doctor has the option either to lower your dose over time, taking care to minimize withdrawal symptoms or cravings, or to abruptly discontinue SUBOXONE Film.

If you feel at risk for relapse during tapering, you can be stabilized and continue maintenance for as long as you and your doctor decide it is necessary. Some patients may remain in the maintenance phase longer. If necessary, patients can restart maintenance treatment with SUBOXONE Film.

You should know: Long-term use of SUBOXONE Film can result in physical dependence. Never stop taking SUBOXONE Film without first talking with your doctor. If you abruptly stop treatment with SUBOXONE Film, or reduce the amount you take too quickly, you could experience withdrawal symptoms.

What happens if a child puts SUBOXONE Film in his or her mouth by accident?

Children who take SUBOXONE Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical.

If a child is exposed to SUBOXONE Sublingual Film, remove any remnants of the film and seek medical attention immediately. Go to the nearest emergency room right away, and call the local Poison Control Center.

Medical personnel will be able to monitor the child's breathing and other symptoms, which is why it is so important to have the child assessed immediately. The active ingredient in SUBOXONE Film, buprenorphine, can stay in the body for a long time, so it is critical that the child be monitored for at least 24 hours. Reckitt Benckiser Pharmaceuticals Inc. has received multiple reports of deaths in children under 6 years of age from buprenorphine tablets.

Keep SUBOXONE Film out of the sight and reach of children.

Because children often imitate adults, do not open your SUBOXONE Film or take it in front of children.

SUBOXONE Film is individually packaged in unit-dose, child-resistant1 packaging. Patients should keep SUBOXONE Film in a secure place, out of the sight and reach of children and other household members.

What happens if an adult takes SUBOXONE Film by accident?

Buprenorphine can cause adverse reactions similar to other opioids, including slowed breathing and other symptoms that need to be assessed and monitored medically. Seek medical attention immediately and go to the nearest emergency room right away and call the local Poison Control Center.

It's important to know that combining buprenorphine with other drugs or medications that cause respiratory depression, such as benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol can be fatal to people dependent on opioids, as well as people who have not had recent experience with opioids. A complete understanding of what other substances and medications a person has taken is crucial.

You should know: There have been reported deaths of opioid naive individuals who received a 2 mg dose of buprenorphine as a sublingual tablet for analgesia. SUBOXONE Film is NOT appropriate as an analgesic.

  1. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA. Child resistance: Meets the Consumer Product Safety Commission's standards for child resistance. During testing, one 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. If a child takes the medication, seek immediate emergency care.
  2. SUBOXONE Sublingual Film [package insert]. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc., August 2010.
  3. Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.

SBF-0319-r1Jun2014

Indication

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used 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.

Important Safety Information

Do not take SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Sublingual Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Sublingual Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Sublingual Film.

You should not drink alcohol while taking SUBOXONE Sublingual Film, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your doctor may monitor liver function before and during treatment.

SUBOXONE Sublingual Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Sublingual Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

Keep SUBOXONE Sublingual Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Sublingual Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Sublingual Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting SUBOXONE may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE Sublingual Film, tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant while taking SUBOXONE Sublingual Film, alert your doctor immediately and you should report it using the contact information provided below.*

Neonatal withdrawal has been reported following the use of buprenorphine by the mother during pregnancy.

Before taking SUBOXONE Sublingual Film, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. SUBOXONE can pass into your breast milk. You and your doctor should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Sublingual Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Sublingual Film affects you. Buprenorphine in SUBOXONE Sublingual Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE Sublingual Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

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

For more information about SUBOXONE Sublingual Film or SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII), please see full Prescribing Information and Medication Guide at www.SuboxoneREMS.com.
SBF-0090-r2May2014