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 I should know about PEXEVA®?

PEXEVA and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
  • PEXEVA and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when PEXEVA is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety or panic attacks
  • feeling agitated, restless, angry or irritable
  • trouble sleeping
  • an increase in activity or talking more than what is normal for you
  • other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. PEXEVA may be associated with these serious side effects:

2. Serotonin Syndrome. This condition can be life-threatening and may include:
  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
3. Visual problems
  • eye pain
  • changes in vision
  • swelling or redness in or around the eye
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

4. Severe allergic reactions:
  • trouble breathing
  • swelling of the face, tongue, eyes or mouth
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain
5. Abnormal bleeding: PEXEVA and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID's, like ibuprofen or naproxen), or aspirin.

6. Seizures or convulsions

7. Manic episodes:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems
Do not stop PEXEVA without first talking to your healthcare provider. Stopping PEXEVA too quickly may cause serious symptoms including:
  • anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
  • headache, sweating, nausea, dizziness
  • electric shock-like sensations, shaking, confusion
Who should not take PEXEVA?

Do not take PEXEVA if you:
  • are allergic to paroxetine mesylate or any of the ingredients in PEXEVA. See the end of this Medication Guide for a complete list of ingredients in PEXEVA.
  • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI.
  • 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.
  • People who take PEXEVA close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
    • high fever
    • uncontrolled muscle spasms
    • stiff muscles
    • rapid changes in heart rate or blood pressure
    • confusion
    • loss of consciousness (pass out)
  • take Mellaril® (thioridazine). Do not take Mellaril® together with PEXEVA because this can cause serious heart rhythm problems or sudden death.
  • take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
What should I tell my healthcare provider before taking PEXEVA? Ask if you are not sure.
Before starting PEXEVA, tell your healthcare provider if you:
  • are pregnant, may be pregnant, or plan to become pregnant. There is a possibility that PEXEVA may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks include a serious condition in which there is not enough oxygen in the baby's blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used PEXEVA® during pregnancy.
  • are breastfeeding. PEXEVA passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking PEXEVA.
  • are taking certain drugs such as:
    • triptans used to treat migraine headache
    • other antidepressants (SSRI's, SNRI's, tricyclics, or lithium) or antipsychotics
    • drugs that affect serotonin such as lithium, tramadol, tryptophan, St. John's wort
    • certain drugs used to treat irregular heart beats
    • certain drugs used to treat schizophrenia
    • certain drugs used to treat HIV infection
    • certain drugs that affect the blood such as warfarin, aspirin, and ibuprofen
    • certain drugs used to treat epilepsy
    • atomoxetine
    • cimetidine
    • fentanyl
    • metoprolol
    • pimozide
    • procyclidine
    • tamoxifen
  • have liver problems
  • have kidney problems
  • have heart problems
  • have or had seizures or convulsions
  • have bipolar disorder or mania
  • have low sodium levels in your blood
  • have a history of a stroke
  • have high blood pressure
  • have or had bleeding problems
  • have glaucoma (high pressure in the eye).
If you take PEXEVA, you should not take any other medicines that contain paroxetine including: PAXIL® and PAXIL CR®.

What should I avoid while taking PEXEVA?
PEXEVA can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how PEXEVA affects you. Do not drink alcohol while using PEXEVA.

What are the possible side effects of PEXEVA?
PEXEVA may cause serious side effects, including all of those described in the section entitled "What is the most important information I should know about PEXEVA?" Common possible side effects in people who take PEXEVA include:
  • Nausea
  • Sleepiness
  • Weakness
  • Dizziness
  • Feeling anxious
  • Trouble sleeping
  • Sexual problems
  • Sweating
  • Shaking
  • Not feeling hungry
  • Dry mouth
  • Constipation
  • Infection
  • Yawning
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PEXEVA. For more information, ask your healthcare provider or pharmacist.

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