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Public Forum to Discuss Addiction as a Treatable Disease and Highlight National Alcohol and Drug Addiction Recovery Month
Date:9/12/2007

) (buprenorphine HCl/naloxone HCl dihydrate [2 mg/0.5 mg and 8 mg/2 mg]) C-III Sublingual Tablets and Subutex(R) (buprenorphine HCl [2 mg and 8 mg]) C-III Sublingual Tablets, formulations of buprenorphine used to treat opioid dependence in a medical office-based setting. Suboxone and Subutex, manufactured by Reckitt Benckiser Healthcare Ltd., are the only controlled medications under the Drug Addiction Treatment Act of 2000 approved by the FDA for office-based treatment of opioid dependence. Reckitt Benckiser Pharmaceuticals Inc. is committed to expanding access to medical therapies for patients suffering from the chronic, relapsing brain disease of opioid dependence. For more information, visit suboxone.com or opioiddependence.com. Reckitt Benckiser Pharmaceuticals Inc. is a wholly owned subsidiary of Reckitt Benckiser PLC, a publicly traded UK firm.

Statement of Fair Balance

SUBOXONE(R) (buprenorphine/naloxone sublingual tablets) is indicated for the treatment of opioid dependence.

Buprenorphine, usually by the intravenous route, in combination with benzodiazepines or other CNS depressants has been associated with significant respiratory depression and death.

SUBOXONE has potential for abuse and produces dependence of the opioid type with a milder withdrawal syndrome than full agonists.

Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.

There are no adequate and well controlled studies of SUBOXONE (a Category C medication) in pregnancy.

Caution should be exercised when driving cars or operating machinery.

Always store buprenorphine containing medications safely and out of the reach of children and destroy any unused medication appropriately.

The most commonly reported adverse events with SUBOXONE include headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), nausea (15%, placebo 11%), insomnia (14%, placeb
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SOURCE Reckitt Benckiser Pharmaceuticals Inc.
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