INGREDIENTS

Each SUBOXONE SUBLINGUAL FILM 2/0.5 contains 2mg buprenorphine (as hydrochloride) + 0.5mg naloxone (as hydrochloride dihydrate) as active ingredients. Each SUBOXONE SUBLINGUAL FILM 4/1 contains 4mg buprenorphine (as hydrochloride) + 1mg naloxone (as hydrochloride dihydrate) as active ingredients. Each SUBOXONE SUBLINGUAL FILM 8/2 contains 8mg buprenorphine (as hydrochloride) + 2mg naloxone (as hydrochloride dihydrate) as active ingredients. Each SUBOXONE SUBLINGUAL FILM 12/3 contains 12mg buprenorphine (as hydrochloride) + 1mg naloxone (as hydrochloride dihydrate) as active ingredients.

SUBOXONE SUBLINGUAL FILM also contains the following inactive ingredients: acesulfame potassium, citric acid, maltitol, hypromellose, polyethylene oxide, sodium citrate, Natural Lime flavour 3000180, Sunset Yellow FCF and a white printing.

UNSTABLE PATIENTS.

Healthcare providers will need to decide when they cannot appropriately provide further management for particular patients. For example, some patients may be abusing or dependent on various drugs, or unresponsive to psychosocial intervention such that the healthcare provider does not feel that he/she has the expertise to manage the patient. In such cases, the healthcare provider may want to assess whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a treatment plan established and agreed upon with the patient at the beginning of treatment.

Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment.

SUBOXONE sublingual film is supplied as an orange rectangular film with a white printed logo in four dosage strengths:

Buprenorphine, like other opioids, may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and changes in the level of consciousness that may interfere with patient evaluation.