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

How to take SUBOXONE Film

SUBOXONE Film, a prescription medicine indicated for treatment of opioid dependence, should be used as part of a complete treatment plan to include counseling and psychosocial support.

Treatment should begin under the supervision of a doctor. The doctor must be qualified under the Drug Addiction Treatment Act of 2000. In appropriate patients, treatment may continue at home with follow-up visits to a doctor at reasonable intervals.

Medication-assisted treatment with buprenorphine, one of the active ingredients in SUBOXONE Film, may help reduce the craving for opioids. To be sure to get your full dose of medication, take SUBOXONE Film as prescribed and using the proper technique. Review this video or slide show, and see the Medication Guide that accompanies your prescription for full administration instructions. Call your doctor's office with any questions.

Keep your SUBOXONE Film in a secure place out of the sight and reach of children.

Figure 1

Always take SUBOXONE Film exactly as your doctor tells you. Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.

  • Do not take SUBOXONE Film more often than prescribed by your doctor.
  • Each SUBOXONE Film comes in a sealed child-resistant foil pouch. Wait to open SUBOXONE Film until right before you use it.

To open your SUBOXONE Film foil pouch, fold along the dotted line (see Figure 1).

Figure 2

Tear down at slit or cut with scissors along the arrow (see Figure 2).

Before taking SUBOXONE Film, drink water to moisten your mouth. This helps the film dissolve more easily.

Figure 3
  • Hold the film between two fingers by the outside edges.
  • Place SUBOXONE Film under your tongue, close to the base either to the left or right of the center (see Figure 3).

  • If your doctor tells you to take 2 films at a time, place the second film under your tongue on the opposite side. Try to avoid having the films touch as much as possible.
  • Keep the films in place until they have completely dissolved.
  • If you are directed to take a third film, place it under your tongue on either side after the first 2 films have dissolved.
  • While SUBOXONE Film is dissolving, do not chew or swallow the film because the medicine will not work as well.
  • Talking while the film is dissolving can affect how well the medicine in SUBOXONE Film is absorbed.
  • If you miss a dose of SUBOXONE Film, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.
  • Do not stop taking SUBOXONE Film 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. To have fewer withdrawal symptoms, ask your doctor how to stop using SUBOXONE Film the right way.

    If you take too much SUBOXONE Film or overdose, get emergency medical help right away.

    Please see full Prescribing Information and Medication Guide for SUBOXONE Film.
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Watch the video to see how to take SUBOXONE Film. If you have any questions, talk with your doctor.



SBF-0423-oOct2014

Selected Safety Information

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

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.SuboxoneFilmREMS.com.