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Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Response to Citizen's Petition
Date:2/25/2013

uals ages 26-49 saw the largest increase in nonmedical use of prescription opioid painkillers, taking the drugs 200 or more days a year.

Selected Safety Information
SUBOXONE (buprenorphine and naloxone) Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Adverse events commonly 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.

Indication
SUBOXONE Sublingual Film 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.

Important Safety Information
SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typi
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SOURCE Reckitt Benckiser Pharmaceuticals Inc.
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