IMPORTANT SAFETY INFORMATION

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

Keep 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, get emergency help right away.

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

• You feel faint, dizzy or confused
• Your breathing gets much slower than is normal for you

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

• Do not stop taking SUBOXONE sublingual film without talking to your healthcare provider. You could also become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
• Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
• SUBOXONE Film is not for occasional or “as needed” use.

Life‑threatening breathing problems, an overdose and even death can also 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.

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

• Injecting SUBOXONE Film may cause death, overdose, life‐threatening breathing problems or infections and other serious health problems.
• Injecting SUBOXONE Film may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

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 also against the law.

SUBOXONE Film, tell your healthcare provider about all of your medical conditions, including:

• Liver or kidney problems
• Trouble breathing or lung problems
• An enlarged prostate gland (men)
• A head injury or brain problem
• Problems urinating
• A curve in your spine that affects your breathing (scoliosis)
• Gallbladder problems
• Adrenal gland problems
• Addison’s disease
• Low thyroid hormone levels (hypothyroidism)
• A history of alcoholism
• Mental problems such as hallucinations (seeing or hearing things that are not there)
• Are pregnant or plan to become pregnant. Opioid‑dependent women on buprenorphine maintenance therapy may require also additional analgesia during labor. If you take SUBOXONE Film while pregnant, your baby may also have signs of opioid withdrawal at birth. Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed. The active ingredients  can also pass into your milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment. Also watch your baby for increased drowsiness and breathing problems.

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