SUBOXONE^® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

Do not take SUBOXONE Sublingual Film if you are hypersensitive to buprenorphine or naloxone.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Sublingual Film contains buprenorphine, an opioid that can cause physical dependence. Chronic use of SUBOXONE Sublingual Film can cause physical dependence. Do not stop taking SUBOXONE Sublingual Film without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.

SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film.

Liver function should be monitored before and during treatment.

Keep SUBOXONE Sublingual Film out of the sight and reach of children. Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, breathing problems.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Do not inject or take SUBOXONE Sublingual Film before the effects of opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Neonatal withdrawal has been reported. Use of products containing buprenorphine in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Pregnancy is considered an adverse event in patients taking buprenorphine-containing products. All pregnancy exposures should be reported (see below). Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment as patients may experience drowsiness and slow reaction time.

Common side effects observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

SUBOXONE^® and Here to Help^® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.

SUBOXONE Film is manufactured for Reckitt Benckiser Pharmaceuticals Inc.,
Richmond, VA 23235 by MonoSol Rx LLC, Warren, NJ 07059.

© 2012 Reckitt Benckiser Pharmaceuticals Inc.