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

Treatment with SUBOXONE Film

FIND A TREATMENT PROVIDER

SUBOXONE Film is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

If a doctor, nurse practitioner or physician assistant waivered to treat opioid dependence prescribes SUBOXONE Film, your treatment can begin. The following are potential stages of treatment with SUBOXONE Film. Only your healthcare provider can decide what is an appropriate treatment plan for you.

  1. Induction—you begin your treatment (or restart it if you've relapsed) under the supervision of a healthcare provider. For your first dose, you must be in a moderate state of withdrawal. You work with your healthcare provider to reach a dose of SUBOXONE Film that works for you.
  2. Maintenance—Your healthcare provider will help you to transition to the maintenance phase of treatment when you:
    • Are no longer experiencing withdrawal symptoms
    • Have minimal to no side effects
    • Do not have uncontrollable cravings

    In the maintenance phase, you may be taking your medication regularly as prescribed. You should comply with all of the elements in your treatment plan including responsibly handling the medication, staying free from illicit drug use, and seeking counseling and/or psychosocial support.

  3. Medical taper—The decision to discontinue therapy with SUBOXONE Film after a period of maintenance should be made as part of a comprehensive treatment plan. It is important that you work with your doctor, nurse practitioner or physician assistant to determine when the time is right to slowly lower your dose, taking care to minimize withdrawal symptoms. Throughout treatment, you should discuss any concerns you have about relapse with your healthcare provider.
Selected Safety Information

SUBOXONE Film can cause serious side effects, including:

  • Respiratory problems. You have a higher risk of death and coma if you take SUBOXONE Film with other medicines, such as benzodiazepines.
  • Sleepiness, dizziness, and problems with coordination.
  • Dependency or abuse. SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit.
  • Liver problems. Call your healthcare provider right away if you notice any of these signs of liver problems:
    • your skin or the white part of your eyes turning yellow (jaundice)
    • urine turning dark
    • stools turning light in color
    • you have less of an appetite
    • you have stomach (abdomen) pain or nausea

    Your healthcare provider should do tests before you start taking and while you take SUBOXONE Film.

  • Allergic reaction. You may have a rash, hives, swelling of the face, wheezing, or a loss of blood pressure and consciousness. Call a healthcare provider or get emergency help right away.
  • Opioid withdrawal. This can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches. Tell your healthcare provider if you develop any of these symptoms.
  • Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
  • Common side effects of SUBOXONE Film include:
    • nausea
    • vomiting
    • drug withdrawal syndrome
    • headache
    • sweating
    • numb mouth
    • constipation
    • swollen and/or painful tongue
    • the inside of your mouth is more red than normal
    • intoxication (feeling lightheaded or drunk)
    • disturbance in attention
    • irregular heart beat (palpitations)
    • decrease in sleep (insomnia)
    • blurred vision
    • back pain
    • fainting
    • dizziness
    • sleepiness

    Tell your healthcare provider about any side effect that bothers you or that does not go away.

  • Long‑term (chronic) use of opioids, including SUBOXONE, may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

For more information on adverse events click here.

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IMPORTANT SAFETY INFORMATION AND INDICATION

What is the most important information I should know about SUBOXONE Film?
Keep SUBOXONE Film in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidently uses SUBOXONE Film, get emergency help right away.

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

INDICATION

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SUBOXONE Film?

Keep SUBOXONE Film in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidently uses SUBOXONE Film, get emergency help right away.

SUBOXONE Film can cause serious and life‑threatening breathing problems. Call your healthcare provider right away or get emergency help if:

These can be signs of an overdose or other serious problems.

Do not switch from SUBOXONE Film to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of SUBOXONE Film is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of SUBOXONE Film that may be different than other buprenorphine containing medicines you may have been taking.

SUBOXONE sublingual film contains an opioid that can cause physical dependence with chronic use.

Life‑threatening breathing problems, an overdose and even death can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using SUBOXONE Film. Ask your healthcare provider what you should do if you are taking one of these.

Call your healthcare provider or get emergency help right away if you:

Do not inject (“shoot‐up”) SUBOXONE Film.

In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBOXONE Film.

SUBOXONE film is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your SUBOXONE sublingual film in a safe place to protect it from theft. Never give your SUBOXONE sublingual film to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

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

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

Do not take SUBOXONE Film before the effects of other opioids (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have started to wear off as you may experience withdrawal symptoms.

SUBOXONE Film may not be right for you. Before taking SUBOXONE Film, tell your healthcare provider about all of your medical conditions, including:

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins and herbal supplements. SUBOXONE Film may affect the way other medicines work and other medicines may affect how SUBOXONE Film works. Some medicines may cause serious or life‑threatening medical problems when taken with SUBOXONE Film.

Sometimes the doses of certain medicines may need to be changed if used together. Do not take any medicine while using SUBOXONE Film until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are taking SUBOXONE Film.

Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, antidepressant medicines, sleeping pills, anxiety medicines or antihistamines while using SUBOXONE Film until you have talked with your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

What should I avoid while taking SUBOXONE Film?

What are the possible side effects of SUBOXONE Film?

SUBOXONE Film can cause serious side effects, including:

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

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

For more information about SUBOXONE Film, see the full Prescribing Information, and Medication Guide or talk to your healthcare provider. For REMS information visit www.suboxoneREMS.com.