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Privacy Policy

At Mallinckrodt Pharmaceuticals we understand that protecting your privacy is important and that your health information is particularly sensitive. We only collect personally identifiable information about you if you choose to give it to us. Please review this Privacy Statement to learn more about how Mallinckrodt Pharmaceuticals collects, uses, shares and protects information online.

Mallinckrodt Pharmaceuticals shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfill business transactions, and we also may share personally identifiable data with our company's affiliates. However, we do not share any of your personally identifiable information with third parties for their own marketing use.


INFORMATION COLLECTED


Information You Give Us

At our Web sites, we only collect your personally identifiable information (such as your name, address, telephone number or e-mail address) when you choose to submit it to us. For example, you may choose to register to receive additional product information or information about a disease state that interests you.

In some cases, we also remove personal identifiers from data and maintain it in aggregate form. We may combine this data with other information to produce anonymous, aggregated statistical information helpful to us in improving our products and services.

Automatically Collected Information

We automatically receive certain types of information whenever you interact with us on our Web sites and in some e-mails we may send each other. Automatic technologies we use may include, for example, Web server logs and IP addresses, cookies and Web beacons.

Web Server Logs and IP Addresses

An IP address is a number assigned to your computer whenever you access the Internet. All computer identification on the Internet is conducted with IP addresses, which allow computers and servers to recognize and communicate with each other. Mallinckrodt Pharmaceuticals collects IP addresses to conduct system administration and report aggregate information to affiliates, business partners and/or vendors to conduct site analysis and Web site performance review.

Cookies

A cookie is a piece of information that is placed on your computer when you access certain Web sites. The cookie uniquely identifies your browser to the server. Cookies allow us to store information on the server to help make the Web experience better for you and to conduct site analysis and Web site performance review. Most Web browsers are set up to accept cookies, although you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

Web Beacons

On certain Web pages or e-mails, Mallinckrodt Pharmaceuticals may utilize a common Internet technology called a "Web beacon" (also known as an "action tag" or "clear GIF technology.") Web beacons help analyze the effectiveness of Web sites by measuring, for example, the number of visitors to a site or how many visitors clicked on key elements of a site. Web beacons, cookies and other tracking technologies do not automatically obtain personally identifiable information about you. Only if you voluntarily submit personally identifiable information, such as by registering or sending e-mails, can these automatic tracking technologies be used to provide further information about your use of the Web sites and/or interactive e-mails to improve their usefulness to you.

YOUR CHOICES

You have several choices regarding your use of our Web sites. Mallinckrodt Pharmaceuticals may require you to provide certain personally identifiable information in order for you to receive additional product information or information about a disease state. You could decide not to submit any personally identifiable information at all by not entering it into any forms or data fields on our sites and not using any available personalized services. Certain sites may ask for your permission for certain uses of your information and you can agree to or decline those uses. If you opt-in for particular services or communications, such as an e-newsletter, then you may be able to unsubscribe at any time by following the instructions included in each communication. If you decide to unsubscribe from a service or communication, then we will work to remove your information promptly, although we may require additional information before we can process your request.

As described above, if you wish to prevent cookies from tracking you anonymously as you navigate our sites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

USE OF DATA

Mallinckrodt Pharmaceuticals and/or the companies we hire to perform services on our behalf will use any personally identifiable information you choose to give us to comply with your requests or as otherwise disclosed to you in this Statement or on the Web page where you submit your information to us. We may refer to this information to better understand your needs and how we can improve our products and services.

We use aggregated (non-personally identifiable) information to help us understand trends and customer needs. For example, we may analyze the gender or age of visitors to Web sites about a particular medication or disease state, and we may use that analysis of aggregate data internally or share it with others.

DATA SHARING AND TRANSFER

General

Mallinckrodt Pharmaceuticals shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfill business transactions, such as providing customer services, sending marketing communications about our products, services and offers, and doing technological maintenance. We also may share personally identifiable data with our company's affiliates.

We may also disclose personally identifiable information for these purposes:

  • In connection with the sale, assignment or other transfer of the business of the Web site to which the data relates;
  • To respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders, or government regulations; or
  • Where needed for corporate audits or to investigate or respond to a complaint or security threat.

No Third-Party Direct Marketing Use

Mallinckrodt Pharmaceuticals will not sell or otherwise transfer the personally identifiable information you provide to us at our Web sites to any third parties for their own direct marketing use.

E-mail a Friend or Colleague

On some Mallinckrodt Pharmaceuticals Web sites, you can choose to send a link or a message to a friend or colleague referring them to a Mallinckrodt Pharmaceuticals Web site. E-mail addresses you may provide for a friend will be used to send your friend information on your behalf and will not be collected or used by Mallinckrodt Pharmaceuticals or other third parties for additional purposes.

LINKS TO OTHER SITES

Our sites contain links to a number of Web sites that may offer useful information to our visitors. This Privacy Statement does not apply to those sites, and we recommend communicating to them directly for information on their privacy policies.

MISCELLANEOUS

Privacy Statement for Children

Our Web sites are not intended or designed to attract children under the age of 13. We do not collect any personally identifiable information from anyone we know to be under the age of 18.

Additional Information on Web Sites

If a Web site has particular provisions relating to privacy that differ from those stated here, then those provisions will be disclosed to you on the page on which personally identifiable information is collected.

Note to Users of Business or Professional Web Sites

If you have a business or professional relationship with Mallinckrodt Pharmaceuticals, then we may use information you submit on our Web sites, including sites intended specifically for business and professional users, to fulfill your requests and develop our business relationship with you and the entities you represent. We also may share such information with third parties acting on our behalf.

Updates to Privacy Statement

From time to time, Mallinckrodt Pharmaceuticals may revise this Privacy Statement. Any such changes to this Privacy Statement will be promptly communicated on this page. Continued use of our sites after receiving notice of a change in our Privacy Statement indicates your consent to the use of newly submitted information in accordance with the amended Mallinckrodt Pharmaceuticals Privacy Statement. The effective date of this Privacy Statement is March 26, 2010.

HOW TO CONTACT US

If you have any questions about the Mallinckrodt Pharmaceuticals Privacy Statement or the information practices of our Web sites, then you may contact us as follows:

Mallinckrodt Pharmaceuticals
675 McDonnell Blvd.
Building 10-3-S
Hazelwood, MO 63042
Attention: Stuart Kim, J.D., Legal Department

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII)

USE

EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII) is used to treat pain that is painful enough to need this type of medicine throughout the entire day in people who have been regularly taking similar pain medicines. EXALGO is an opioid (narcotic). It has risks of addiction, abuse, misuse, overdose, and death, even when taken at the dose your doctor prescribed. Because of this, EXALGO should be used only when other medicines don't work. EXALGO is not used as an as-needed pain reliever.

 

IMPORTANT RISK INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
BREATHING PROBLEMS; ACCIDENTAL USE; WITHDRAWAL SYNDROME IN NEWBORNS

Addiction, Abuse, and Misuse

Addiction, abuse, and misuse of EXALGO can lead to overdose and death.

Life-threatening Breathing Problems

EXALGO can cause severe breathing problems that can kill you. Crushing, chewing, or dissolving EXALGO can cause you to get too much medicine, which can kill you.

Accidental Use

Taking EXALGO by mistake can cause overdose and death, especially in children.

Withdrawal Syndrome in Newborns

Taking EXALGO while pregnant can cause withdrawal in your newborn baby. It may kill them if they are not treated.

DO NOT USE EXALGO IF:

  • You were not previously taking another opioid (narcotic) pain medicine.
  • You have severe asthma or other breathing problems.
  • You have a bowel blockage.
  • You have had previous surgeries or disease that caused your stomach or bowels to become narrower.
  • You are allergic to hydromorphone, sulfites, or any other ingredient.

WARNINGS:

  • EXALGO is a controlled substance. It has risks of abuse, misuse, and addiction like other opioid medicines used for pain. Crushing, chewing, snorting, or injecting EXALGO can cause overdose and death. Injecting the inactive ingredients in EXALGO can damage your heart, which can kill you. Drug abuse by injection can also cause the spread of diseases such as hepatitis and HIV (AIDS).
  • EXALGO can cause severe breathing problems that can kill you, even when it is used as your doctor prescribed. The risk of severe breathing problems is highest when you first start taking EXALGO or when your dose is increased. People who are elderly or who already have severe breathing problems have a higher chance of having severe breathing problems when they take EXALGO.
  • Low blood pressure, excessive sedation, severe breathing problems, and death can occur if you take EXALGO with certain other medicines. These include drugs to treat anxiety or help you sleep, similar pain medicines, or alcohol.
  • The use of EXALGO could result in low blood pressure.
  • EXALGO may complicate head injuries.
  • EXALGO may aggravate seizures in people who experience seizures.
  • Do not abruptly stop taking EXALGO.
  • EXALGO could affect your ability to drive a car, use machinery, or do other dangerous tasks.

SIDE EFFECTS:

  • Serious side effects include severe breathing problems which can kill you, overdose, and death.
  • The most common side effects are constipation, nausea, vomiting, drowsiness, headache, fatigue/lack of strength, and dizziness.

USE IN CERTAIN POPULATIONS:

  • Babies born to mothers who use opioids like EXALGO could have trouble breathing and symptoms of withdrawal.
  • EXALGO passes into breast milk. It may harm your baby if you breastfeed.
  • EXALGO is not approved for children.

 

Please see Medication Guide for Important Risk Information and Full Prescribing Information.

IMPORTANT RISK INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
BREATHING PROBLEMS; ACCIDENTAL USE; WITHDRAWAL SYNDROME IN NEWBORNS

Addiction, Abuse, and Misuse

Addiction, abuse, and misuse of EXALGO can lead to overdose and death. Click here for more Important Risk Information, including full boxed warning