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

Recognize some of the signs of opioid dependence

FIND A TREATMENT PROVIDER

Recognizing potential signs of opioid dependence is important for taking action to get help. Only a licensed healthcare provider is able to diagnose opioid dependence. The list below is provided for guidance and may not be comprehensive. If you have concerns, talk to a healthcare provider today.

It's important to be honest with your healthcare provider.

Once you are evaluated, you and your healthcare provider can plan your next steps.

Recognize some of the signs:

A variety of symptoms are associated with opioid addiction. Symptoms of opioid addiction may include a strong desire for opioids, an inability to control or reduce use, continued use despite interference with major obligations or social functioning, use of larger amounts over time, development of tolerance, spending a great deal of time obtaining and using opioids, and withdrawal symptoms that occur after stopping or reducing use, such as negative mood, nausea or vomiting, muscle aches, diarrhea, fever, and insomnia.

If you think you have a problem, the only person who can diagnose you is a healthcare provider. There are healthcare providers and treatment options that may be able to help.

flying blue bird
SEE MORE

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.