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.
- For dependence on short‑acting opioids, like heroin or prescription painkillers, SUBOXONE Film, which contains buprenorphine and naloxone, may be recommended to help you begin and maintain continuity of treatment
- When transitioning from dependence on long‑acting opioids, like methadone, a buprenorphine‑only medication may be recommended
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.
- 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.
- 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.
- 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.
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:
- drug withdrawal syndrome
- numb mouth
- 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
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.