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

What is SUBOXONE Film?

SUBOXONE® Sublingual Film packaging

SUBOXONE Film is a discreet and effective treatment for opioid dependence. You can begin your treatment in a doctor's office and then take SUBOXONE Film at home—without interrupting your daily routine.

Taking SUBOXONE Film can help reduce your physical withdrawal symptoms and cravings, so you can begin to work toward recovery. Because opioid dependence is a complex condition that involves more than just physical symptoms—it can also affect the way you feel and how you act—SUBOXONE Film should be part of a complete treatment plan to include counseling and behavioral therapy.

SUBOXONE Film basics

  • At the right dose, and along with counseling, SUBOXONE Film can help people stay in treatment and reduce illicit opioid use by suppressing withdrawal symptoms and reducing cravings.
  • Only doctors with special training can get a license to prescribe SUBOXONE Film. Find one near you.
  • SUBOXONE Film is discreet, effective, and doesn't require daily clinic visits, so you can stay on track without disconnecting from your daily life.
  • SUBOXONE Film is an orange, rectangular film that comes individually wrapped in unit-dose, child-resistant packaging.
  • The medication in SUBOXONE Film is absorbed into the bloodstream through blood vessels under your tongue.
  • SUBOXONE Film offers 24/7 online support through the Here to Help® Program, designed to help you learn how to move on from where you've been.

Frequently asked questions about SUBOXONE Film:

Q: 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.

Q: 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.

Q: 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.

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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