Pexeva Tablets (paroxetine mesylate) - Engage in Living

Online Privacy Policy

Welcome to www.Pexeva.com, a web site owned by Noven Therapeutics, LLC. Our Online Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide to this site. Please be sure to read our entire Online 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 Online Privacy Policy. Whenever you submit information to this site, you consent to the collection, use, and disclosure of that information in accordance with this Online Privacy Policy. If you do not agree with this Online Privacy Policy, please do not use our site.

About Children

This site is not intended for children under the age of 13. We do 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 websites.

Information You Provide and Personally Identifiable Information

You can view most of our content anonymously. Some areas of this site may ask you to submit personally identifiable information, treatment information, or demographic information so you can benefit from the specified features (such as newsletter subscriptions or other informative resources) or to participate in a specific activity (such as promotions, including coupons). You will be informed what information is required and what information is optional. Personally identifiable information is information that can be uniquely identified with you such as your full name, address, e-mail address, phone number, etc.

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 website you just came from and the Internet Protocol (IP) address and the browser version your computer is currently using.

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 website sends to your Web browser that helps the site remember information about you and your preferences. 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. 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.

An Internet Protocol (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 nonpersonally 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 website 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.

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 this Online Privacy Policy. 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 Noven affiliates worldwide that agree to treat it in accordance with this Online 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 Noven affiliates, but only:

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

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

Access and Correction

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

Security

Noven 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 know and consider 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 Websites

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

How to Contact Us or Opt Out

If you have any questions, comments, or concerns about this Online 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:

Noven Therapeutics, LLC.
Attn: Online Privacy Policy
11960 SW 144th Street Miami, FL 33186
privacypolicy@noven.com

Changes to This Online Privacy Policy

If this Online 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 Online Privacy Policy was last updated December 2011.

Use of PEXEVA®

PEXEVA® (paroxetine mesylate) is approved for the treatment of major depressive disorder (MDD), obsessive compulsive disorder (OCD), panic disorder (PD), and generalized anxiety disorder (GAD) in adults.

Depression is a serious medical condition that in some people can lead to suicidal thoughts. As with any medication, there are benefits and risks with PEXEVA. It is important to discuss these with your doctor.

IMPORTANT SAFETY INFORMATION

What Is The Most Important Information You Should Know About PEXEVA®?

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should discuss with the healthcare professional right away any worsening depression symptoms, suicidal thinking or behavior, or unusual changes in behavior. PEXEVA is not approved for use in children and teens.

Who should not take PEXEVA®?

    Do not take PEXEVA® if you:

  • Are allergic to paroxetine mesylate or any of its ingredients.
  • Take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.
  • If you are taking Mellaril® (thioridazine) or Orap® (pimozide).
  • If you are taking Paxil® or any other medication that contains paroxetine.
  • Do not take an MAOI within 2 weeks of stopping PEXEVA unless directed to do so by your physician.
  • Do not start PEXEVA if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
What should I tell my healthcare professional about before taking PEXEVA®?
  • Talk with your doctor about your medical conditions, including kidney or liver problems, diabetes, seizures, or bi-polar disease, and your alcohol use.
  • Tell your doctor if you have glaucoma (high pressure in the eye).
  • If you are pregnant or plan to become pregnant. The use of paroxetine during the first 3 months of pregnancy has been shown to increase the risk of severe health problems in the unborn baby. Some of these health problems affect the baby's heart. Use during the last 3 months of pregnancy may cause dangerous lung complications in newborns. For these reasons, women who are pregnant or who plan to become pregnant should discuss other treatment choices with their doctor. Women who are breast feeding should also talk to their doctor before taking PEXEVA.
  • Call your doctor if you have very high fever, rigid muscles, shaking, confusion, or rapid changes in heart rate and blood pressure. These may be signs of a rare but serious side effect called Serotonin Syndrome.
Also talk with your healthcare professional about the following precautions:
  • All patients taking antidepressants should be watched closely for signs that their condition is getting worse or that they are becoming suicidal, especially when they first start therapy, or when their dose is increased or decreased. Patients should also be watched for becoming agitated, irritable, hostile, aggressive, impulsive, or restless. Such symptoms should be reported to the patient's doctor right away. Please read the accompanying Medication Guide.
  • Before starting PEXEVA, tell your doctor if you're taking or plan to take any prescription or over-the-counter drugs, including migraine headache medication (triptans), other antidepressants or antipsychotics, herbal preparations, and nutritional supplements, to avoid a potentially life-threatening condition.
  • Taking PEXEVA with aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen), warfarin, or other drugs that affect coagulation may increase the risk of bleeding events.
  • Some studies have shown that taking PEXEVA with Tamoxifen for breast cancer may reduce the efficacy of Tamoxifen.
  • When people suddenly stop using or quickly lower their daily dose of PEXEVA, discontinuation symptoms may occur. Talk to your doctor before discontinuing or reducing your dose of PEXEVA.
  • Until you see how PEXEVA affects you, be careful doing such activities as driving a car or operating machinery.
  • You should avoid drinking alcohol while on PEXEVA.
What side effects may occur with PEXEVA®?

As discussed above and in the Medication Guide, serious side effects can occur with PEXEVA. The most common side effects that have been reported with PEXEVA include nausea, sleepiness, weakness, dizziness, feeling anxious, trouble sleeping, sexual problems, sweating, shaking, not feeling hungry, dry mouth, constipation, infection, and yawning.

Be sure to tell your doctor how you are feeling.

If you have any questions about PEXEVA, call your doctor. Be sure to let your doctor know if you notice any unusual changes while taking PEXEVA and never stop your medicine or change your dose before speaking with your doctor.

Please see accompanying Medication Guide for PEXEVA and the full Prescribing Information including BOXED WARNINGS-Suicidality and Antidepressant Drugs.

PEX-3503-13