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Important Safety Information (ISI)
SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) is indicated for the treatment of opioid dependence.
It is extremely dangerous to take benzodiazepines or other depressants while taking SUBOXONE. A serious overdose and death may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as SUBOXONE.
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.
Allergic reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients taking 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 and sight of children. 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%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%). Please see full Prescribing Information for a complete list.
To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full US Prescribing Information for SUBOXONE.
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HereToHelpProgram.com respects your privacy.
Read our Privacy Policy for more information.
In order to provide you with the most relevant and useful services through the Here to Help Program, Reckitt Benckiser, the company that created Here to Help, collects certain personal health information from participants. Our Care Coaches will ask you about your medical history, current use of health care services, personal challenges, and other pertinent health information needed to direct you to appropriate resources. Any information that you provide is voluntary. We will do all that is legally required to keep information that you provide confidential.
We will use our best efforts to ensure that any personal information about you that was collected by our Care Coaches will be destroyed when your scheduled communications with Care Coaches are concluded, or at any time earlier at your direction. Reckitt Benckiser may keep information that cannot be linked to you in any way for research purposes. Summaries of such information may be made available publicly, but never if the information summarized relates to only one person.
If you would like to discuss your involvement in the Here to Help Program, call 1-866-670-HERE (866-670-4373).
Reckitt Benckiser Pharmaceuticals Inc. (USA) ("Reckitt Benckiser") respects the privacy of every individual who visits our sites or responds to our interactive advertisements. This Privacy Policy outlines the information Reckitt Benckiser will collect and how we will use that information. This Policy will also instruct you on what to do if you do not want your personal information collected or shared when you visit Reckitt Benckiser sites or respond to our advertisements.
Reckitt Benckiser will not collect any personally identifiable information about you (that is, your name, address, telephone number, or e-mail address) unless you provide it to us voluntarily. For example, and not by limitation, we may collect personally identifiable information when you make a purchase, participate in a contest or sweepstakes promotion; fill out a questionnaire; sign up for a survey or otherwise interact with us.
When you provide personally identifiable information to us, we may ask if you want to receive future communication from us, such as newsletters, e-mail or other information. You can choose not to receive this communication, if you wish and you may opt-out by clicking on the link on the bottom of an e-mail you received or by clicking here.
If you do not want your personally identifiable information collected, please do not submit it to us. If you have already submitted this information and would like for us to remove it from our records, please click here to provide us with the e-mail address.
In addition to providing you with the service or information you request on our site, your personally identifiable information may also be used to help us track the way you use our site and our products. We may also combine the information you provide with information that we collect separately, including information you have provided to other organizations as well as public information. All of this will help us, for instance, better design our products, Websites and advertisements. In order to do this, we may also share your information with companies who carry out work for us. Information may be shared with service providers who provide services for or administer activities on behalf of Reckitt Benckiser (such as, but not limited to, authorization of credit card and check transactions, sweepstakes, promotions and contests). Information you submit to one or more of the Reckitt Benckiser brands may be shared with another of the Reckitt Benckiser brands. Your personally identifiable information may also be shared with service providers who warehouse product, perform order fulfillment or provide hosting services. These companies have agreed to only use your information in the way we tell them and to have procedures in place to protect the information.
In the event a division of Reckitt Benckiser, or its assets, is bought or sold, personally identifiable information may be included among the transferred business assets.
Reckitt Benckiser may disclose specific personally identifiable information if it determines that such disclosure is necessary to comply with the law or to protect the safety of the public. This includes exchanging personally identifiable information with other companies and organizations for fraud protection and credit risk reduction.
If we intend to share your information with an unaffiliated company, other than as set out above, we will contact you first and give you the opportunity to remove your information from our database.
Reckitt Benckiser does not knowingly solicit or collect personally identifiable information (that is, name, address, telephone number, or e-mail address) from individuals under the age of thirteen years. Where appropriate, Reckitt Benckiser will specifically instruct children not to submit such information on our sites or advertisements. If a child has provided us with personally identifiable information, a parent or guardian of that child should click here to provide us with the e-mail address if they would like this information deleted from our records. Reckitt Benckiser will take all reasonable measures to delete such information from its database and to not use such information for any purpose (except where necessary to protect the safety of the child or others or as required by law).
The Reckitt Benckiser Website(s) may contain links to other sites. The privacy policies at these other sites may be different from this one. You should refer to the privacy policy of any site linked to or framed within a Reckitt Benckiser site, or when you are leaving a Reckitt Benckiser site or site(s) for information and the privacy policy pertaining to that site.
In some cases, we may collect information about you that is not personally identifiable. Examples of this type of information include the type of Internet Browser you are using, the type of computer operating system you are using, and the domain name of the site from which you linked to our site or advertisement. We use this information for the purposes of better understanding our customer's interests and to help improve our business and sites.
When you view one of our sites or advertisements, we may store some information on your computer. For example, this information may be in the form of a "Cookie" or similar file that will allow us to tailor a site or advertisement to better match your interests and preferences. With most Internet Browsers, you can erase Cookies from your computer hard drive, block all Cookies, or receive a warning before a Cookie is stored. Please refer to your Browser instructions or help screen to learn more about these functions. Please note that removing or blocking Cookies may interfere with your full use of our site. You may need to download applications and readjust your security settings to access some or all of the information on one or more of the Reckitt Benckiser site(s).
Reckitt Benckiser uses industry standard security techniques to help protect against the loss, misuse or alteration of information collected from you at a Reckitt Benckiser site. When you transmit personally identifiable information, that information is stored on servers that Reckitt Benckiser has attempted to secure from unauthorized access or intrusion. Of course, the Reckitt Benckiser sites cannot be and are not responsible for unauthorized access to information by hackers who have obtained such access through illegal measures.
If you have submitted personally identifiable information through a Reckitt Benckiser site or interactive advertisement, and would like that information modified, changed or deleted from our records, please click here to provide us with the e-mail address.
We may modify this Privacy Policy and you should therefore periodically visit this page to be sure that you have read and agree with our most current Privacy Policy. This Privacy Policy was last revised on 18 April 2007 and is effective as of 14 May 2007.
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