Pexeva Tablets (paroxetine mesylate) - Engage in Living

Terms of Use

Welcome to the PEXEVA® brand web site of Noven Therapeutics LLC. This web site is produced by Noven Therapeutics LLC. The information provided on this site is for general information and educational purposes only and may not be used as an alternative to or supplement to healthcare. Nothing on this web site should be considered medical advice. Please consult with your healthcare professional about any medical questions you may have.

Please read these Terms of Use before viewing or using any portion of this web site. By accessing and using the web site, you acknowledge that you have read, understood, and accept all the Terms of Use and will be bound by them. If you do not agree to the Terms of Use, you may not access or otherwise use the web site.

Noven Therapeutics LLC reserves the right, in its sole discretion, to change the Terms of Use at any time, as appropriate. Your continued use of the web site following such changes shall be deemed your acceptance of the changes.

The products and product information on this web site are intended only for residents of the United States and its territories who generally are 18 years of age or older. Information on Attention Deficit and Hyperactivity disorder and childhood epilepsy, for example, may be appropriate to help adolescents 13 years of age or older discuss these topics with their parent(s), caregiver(s), or healthcare professional(s). The products discussed on this web site may not be available in all countries or may be available under different names, in different strengths or formulations. Noven Therapeutics LLC products should only be used or administered consistent with approved labeling and pursuant to your healthcare professional's direction.

The content of this site is protected under applicable copyright and trademark laws. Product names are registered trademarks of Noven Therapeutics LLC, its subsidiaries, affiliates, or alliance partners unless otherwise noted. The use or misuse of any copyrighted or trademarked materials, expect as expressly permitted herein, is expressly prohibited and may be in violation of copyright, trademark, or other applicable law. Nothing contained on this web site shall be considered as conferring any license or right to use any patent or trademark or copyright of Noven Therapeutics LLC or any third party. Your use of information on this site is subject to the terms of this section. You may print a single copy of the content for your own personal noncommercial use, provided any copy of these documents that you make retains all copyright or other proprietary notices and any disclaimer contained thereon. The further copying, redistribution or publication of any part of this site is prohibited. If you link to any third-party web sites from this web site, you should follow the copyright provisions of those sites. Reasonable efforts have been made to provide accurate and current information on this web site, but it is not comprehensive in scope. Noven Therapeutics LLC makes no representation as to the availability, accuracy or completeness of the content of this site.

THIS WEB SITE IS PROVIDED "AS IS" AND THE COMPANY MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. THE COMPANY DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE WEB SITE WILL BE UNINTERRUPTED OR ERROR FREE OR THAT THE WEB SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO PART OF THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.

In no event and under no circumstances shall Noven Therapeutics LLC, its affiliates, and subsidiaries, and their respective officers, directors, employees, agents, representatives, information providers and licensors, and their respective heirs and assigns be liable for any direct, indirect, incidental, consequential, special exemplary, punitive or other damages, even if informed of the possibility of such damages, resulting from your access to, or inability to access, this site or from your reliance on any information on this site. Noven Therapeutics LLC shall not be liable for any damages or injury resulting from your access to, or inability to access, this site or from your reliance on any information on this site.

You agree that all access and use of this Web site and its content is at your own risk. You further agree that you will not upload, post, transmit, distribute or otherwise publish through the web site any materials that: 1) restrict or limit the ability of any other User to use this web site; 2) are unlawful, threatening, abusive, libelous, defamatory, obscene, pornographic, profane, or indecent; 3) constitute or encourage conduct that would be a criminal offense, give rise to civil liability, or otherwise violate the law; 4) violate, plagiarize, or infringe the rights of any third parties; or 5) contain a virus or other harmful or potentially harmful component.

You agree to indemnify, defend, and hold harmless Noven Therapeutics LLC, its affiliates, and subsidiaries, and their respective officers, directors, employees, agents, representatives, information providers and licensors, and their respective heirs and assigns from and against any and all losses, expenses, damages, and costs, including attorneys' fees, resulting from any violation by you of the Terms of Use.

This site may provide links to other web sites maintained by third parties over which Noven Therapeutics LLC has no control. Noven Therapeutics LLC is not responsible for accuracy or any other aspect of the information contained on such sites and shall not be liable for any damages or injury arising from users' access to such sites. Links to other sites are provided only as a convenience to users of our site. Noven Therapeutics LLC makes no representations or warranties of any kind as to the accuracy, completeness, or currency of any information provided on such sites.

Should any visitor to the Noven Therapeutics LLC site provide information such as questions, comments, suggestions, ideas, or the like through any feedback mechanisms located herein, except as set forth in the Noven Therapeutics Online Privacy Policy, Noven Therapeutics LLC shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose, and distribute the information to others without limitation. Please refer to Noven Therapeutics LLC's Online Privacy Policy with respect to users' rights and information that is disclosed on this website.

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