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ULTRAM® ER (tramadol HCl) Extended-Release Tablets For Chronic Pain
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On behalf of Biovail Corporation (manufacturer of ULTRAM® ER), PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. is voluntarily recalling certain lots of ULTRAM® ER. For more information,
click here.


Privacy Policy

Welcome

Welcome to www.ULTRAM-ER.com! This site is owned by PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. This Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this site. Please be sure to read this entire Privacy Policy before using or submitting information to this site. This site is intended for use by residents of the United States.

Your Consent

By using this site, you agree to the terms of this Privacy Policy. Whenever you submit information via this site, you consent to the collection, use, and disclosure of that information in accordance with this Privacy Policy.

About Children

This site is not intended for children under the age of 13. We will not knowingly collect personally identifiable information via this site from visitors in this age group. We encourage parents to talk to their children about their use of the Internet and the information they disclose to Web sites.

Information You Provide

Some areas of this site may ask you to submit personally identifiable information in order for you to benefit from the specified features (such as newsletter subscriptions, tips/pointers, order processing, or resume submission) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed what information is required and what information is optional.

Passive Information Collection

As you navigate through this site, certain anonymous information can be passively collected (that is, gathered without your actively providing the information) using various technologies, such as cookies, Internet tags or web beacons, and navigational data collection (log files, server logs, clickstream). Your Internet browser automatically transmits to this site some of this anonymous information, such as the URL of the Web site you just came from and the Internet Protocol (IP) address and the browser version your computer is currently using. This site may also collect anonymous information from your computer through cookies and Internet tags or web beacons. You may set your browser to notify you when a cookie is sent or to refuse cookies altogether, but certain features of this site might not work without cookies.

This site may use and combine such passively collected anonymous information to provide better service to site visitors, customize the site based on your preferences, compile and analyze statistics and trends, and otherwise administer and improve the site for your use. Such information is not combined with personally identifiable information collected elsewhere on the site unless you have consented.

A "cookie" is a bit of information that a Web site sends to your Web browser that helps the site remember information about you and your preferences.

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"Persistent" cookies are more permanent bits of information that are placed on the hard drive of your computer and stay there unless you delete the cookie. Persistent cookies store information on your computer for a number of purposes, such as retrieving certain information you have previously provided (such as passwords), helping to determine what areas of the Web site visitors find most valuable, and customize the Web site based on your preferences on an ongoing basis. Persistent cookies placed by this site on your computer may hold personally identifiable information, but only if you have registered or have otherwise consented to the retention of personally identifiable information you have provided at the site. Otherwise, our site's server only knows that an unidentified visitor with your cookie has returned to the site.

You can set your browser to accept all cookies, to reject all cookies, or to notify you whenever a cookie is offered so that you can decide each time whether to accept it. To learn more about cookies and how to specify your preferences, please search for "cookie" in the "Help" portion of your browser.

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A site may use Internet Protocol (IP) addresses. An IP address is a number assigned to your computer by your Internet service provider so you can access the Internet and is generally considered to be non-personally identifiable information, because in most cases an IP address is dynamic (changing each time you connect to the Internet), rather than static (unique to a particular user's computer). The IP address can be used to diagnose problems with a server, report aggregate information, determine the fastest route for your computer to use in connecting to a site, and administer and improve the site.

"Internet tags" (also known as single-pixel GIFs, clear GIFs, invisible GIFs, and 1-by-1 GIFs) are smaller than cookies and tell the Web site server information such as the IP address and browser type related to the visitor's computer. Tags may be placed both on online advertisements that bring people to the site and on different pages of the site. Such tags indicate how many times a page is opened and which information is consulted.

"Navigational data" (log files, server logs, and clickstream data) are used for system management, to improve the content of the site, market research purposes, and to communicate information to visitors.


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Use and Disclosure of Information

Except as otherwise stated, we may use information collected via this site to improve the content of our site, to customize the site to your preferences, to communicate information to you (if you have requested it), for our marketing and research purposes, and for any other purpose specified. In addition, we may make full use of all information acquired through this site that is not in personally identifiable form.

If you provide personally identifiable information to this site, we may combine such information with other actively collected information unless we specify otherwise at the point of collection. We may disclose personally identifiable information you provide via this site to other Johnson & Johnson affiliates worldwide that agree to treat it in accordance with this Privacy Policy and use it for the same purposes. We also may disclose personally identifiable information you provide via this site to third parties that are not Johnson & Johnson affiliates, but only:

  1. to contractors we use to support our business (such as fulfillment services, technical support, delivery services, and financial institutions), in which case we will require such third parties to agree to treat it in accordance with this Privacy Policy and use it for the same purposes;

  2. in connection with the sale, assignment, or other transfer of the business of this site to which the information relates, in which case we will require any such buyer to agree to treat it in accordance with this Privacy Policy and use it for the same purposes; or

  3. to respond to law enforcement requests or where required by applicable laws, court orders, or government regulations.

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The collection, use, and disclosure of information contemplated in this Privacy Policy may involve a transfer of the information to jurisdictions located outside your country of residence that may not have equivalent laws and rules regarding personally identifiable information. In these cases, you will be asked to consent to such transfers and disclosures in accordance with this Privacy Policy.

Access, Correction, and Deletion

To keep personally identifiable information that you provide via this site accurate, current, and complete, please contact us as specified below and we will take appropriate steps to update or correct such information in our possession, or to delete your information from our contact list.

Security

This site takes reasonable steps to protect personally identifiable information as you transmit it to our site and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever completely secure or error-free. In particular, e-mail sent to or from this site may not be secure.

Links to Other Web Sites

This site may contain links or references to other Web sites to which this Privacy Policy does not apply. We encourage you to read the Privacy Policy of every Web site you visit.

How to Contact Us

If you have any questions, comments, requests, or concerns related to this Privacy Policy or the information practices of this site, or if you would like to opt out of future communications, please contact us as follows:

Customer Communications Center
PO Box 200
Titusville, New Jersey 08560
800-526-7736

Changes to This Privacy Policy

If this Privacy Policy changes, the revised policy will be posted on this site. Please check back periodically, and especially before you provide any personally identifiable information. This Privacy Policy was last updated on February 7, 2008.


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ULTRAM® ER is used to manage moderate to moderately severe chronic pain in adults who need to be treated around the clock for their pain for an extended period of time.


IMPORTANT SAFETY INFORMATION


Do not take ULTRAM® ER if you have had an allergic reaction to tramadol, codeine, or other opioids in the past. Do not take ULTRAM® ER in any situation where opioids should not be used, including acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. ULTRAM® ER may worsen central nervous system and respiratory depression.


Seizures have been reported in people taking tramadol, the active ingredient in ULTRAM® ER, at recommended doses. The risk of seizures is increased with doses of tramadol above the recommended range. Use of tramadol increases the risk of seizures in people taking antidepressants, other opioids, or other drugs that can cause seizures.


Risk of convulsions may also increase in people with epilepsy, a history of seizures, or a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, and central nervous system infections).


People who are suicidal or have a history of addiction should not take ULTRAM® ER. Use of alcohol should be avoided when taking ULTRAM® ER. Do not take more than the recommended dose of ULTRAM® ER.


ULTRAM® ER may be associated with a potentially life-threatening condition when taken together with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) (classes of drugs for depression or other disorders), triptans, lithium, or St. John's wort. Some common SSRIs are Paxil (paroxetine), Prozac/Sarafem (fluoxetine), and Zoloft (sertraline). Some common SNRIs are Cymbalta (duloxetine) and Effexor (venlafaxine). Some common triptans are Axert (almotriptan), Imitrex (sumatriptan), and Relpax (eletriptan). Symptoms of Serotonin Syndrome can include mental-state changes such as agitation, hallucinations, and coma. Symptoms can also include autonomic instability (e.g. fast heartbeat, fluctuating blood pressure, increased body temperature), neuromuscular aberrations (e.g. overactive reflexes, incoordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).


Serious and rarely fatal anaphylactic (allergic) reactions can occur, even if you have never taken tramadol.


Taking ULTRAM® ER, alone or in combination with alcohol, or medications such as tranquilizers, hypnotics, or other opioids, can cause respiratory depression, seizures, overdose and possibly death. Taking certain medications together can increase the risk of respiratory and central nervous system depression. These medications may include alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, or sedative hypnotics.


Before taking ULTRAM® ER, you should inform your doctor if you have been diagnosed with increased intracranial pressure or have had a head injury.


ULTRAM® ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.


Talk with your doctor about all medications you are taking. These may include antidepressants, tranquilizers, hypnotics, or other opioid pain medicines. If you experience symptoms such as restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, or diarrhea, contact your doctor immediately.


Do not change your dose or stop taking ULTRAM® ER without talking with your doctor first as you may experience withdrawal symptoms.


ULTRAM® ER can be abused or cause dependence. ULTRAM® ER tablets must be swallowed whole. Do not chew, crush, or split the tablet before swallowing. This can lead to overdose and possible serious injury including death. You should not use ULTRAM® ER if you have severe renal impairment.


The most common side effects reported with ULTRAM® ER were dizziness, nausea, constipation, headache, and drowsiness.


Tell your doctor about all your medical conditions and if you are pregnant, think you might be pregnant, or are trying to become pregnant.


Please talk to your healthcare professional for more information or if you have further questions about ULTRAM® ER. You can also call the Ortho-McNeil-Janssen Scientific Affairs, LLC, Customer Communications Center at 1-800-526-7736 for more information. In addition, please visit www.ultram-er.com for full Prescribing Information.


You are 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.


Paxil and Imitrex are registered trademarks of GlaxoSmithKline. Prozac/Sarafem and Cymbalta are registered trademarks of Eli Lilly. Zoloft/Relpax are registered trademarks of Pfizer, Inc. Effexor is a registered trademark of Wyeth. Axert is a registered trademark of Almirall Prodesfarma.

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2008-2010. All rights reserved. Your use of the information on this site is subject to the terms of our Legal Statement. Please see our Privacy Policy.

This site is published by PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, which is solely responsible for its contents. This information is intended for the use of our customers, patients and healthcare professionals in the United States only.


PriCara® recognizes that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside of the United States. Capitalized product names are trademarks of PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

This page was last modified on May 28 2010 at 16:13:28 EDT.


ULTRAM® ER (tramadol HCl) Extended-Release Tablets For Chronic Pain PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc