PRIVACY POLICY

Last updated: July 17, 2015

Thank you for your interest in Meda Pharmaceuticals Inc. Meda invites you to explore our websites and learn more about us and our products. As you do so, please know that Meda respects your privacy and is committed to protecting the personal information that you share with us. This Privacy Policy summarizes our standards for collecting, using, storing and sharing the personal information that we, or companies that work with us, obtain from our websites.

Meda Pharmaceuticals Inc. is the United States subsidiary of Meda AB, a global specialty pharmaceutical company based in Sweden. This Privacy Policy applies only to Meda Pharmaceuticals Inc., and to Meda owned websites, and the data collected within those websites, specifically identified as intended for use only by residents of the United States and its territories that link to this policy.

Meda’s Privacy Policy does not apply to third–party online resources, even if our website offers courtesy links to them. Meda does not control the content or the privacy practices of third–party resources. Read the Privacy Policy of any website or other online resource that you visit to ensure that you understand and agree with it. (That applies to our Privacy Policy too – we want you to read it carefully). If you have questions about our policy, or how Meda protects the privacy of your personal information, you may contact us a privacy@meda.us.

Meda Pharmaceuticals, Inc. reserves the right to update or change this Privacy Policy.

The term "personal information" is used to describe information that can be readily used to identify a specific living person. Examples of personal information that could potentially be collected within a Meda website include an individual’s name, an individual’s street address or an individual’s email address. Information that relates to an individual, but could not be used to identify a specific individual, is not considered “personal information”. For example, the state of residence alone would not be considered personal information, but if this were to be combined with an individual’s street address, this would be considered “personal information” as it could be used to identify a specific individual.

De–identified information is information that has been stripped of features that would permit the identification of the underlying individual. When de–identified information about multiple people is put together, it is referred to as "aggregated" and de–identified information. Meda reserves the right to choose to aggregate personal information obtained from individuals through a variety of different channels. Any data aggregation of personal information will be done in a manner consistent with this Privacy Policy and any additional privacy notifications provided.

Meda collects personal information to improve your experience as a user of Meda’s websites. Collected personal information enables Meda to provide topics of interest that are more relevant to you as a user. In addition, information collected via Meda websites can provide mechanisms to assist with the improvement of Meda products and services as well as help better design features and better identify resources that users would like to see Meda offer.

Meda collects personal information online through websites and other sponsored resources. At times, we will work with other companies that collect personal information at our request. When Meda works with a third party company, the work is regulated by an agreement that, among other things, requires the third party company to properly protect the personal information it collects for us.

There are an assortment of tools that Meda may employ to collect personal information, including, but not limited to:

Direct Collection. This is collecting personal information from you by requesting that you complete an online form or participate in an interactive survey or display. Contact details, such as your name, street address, email address, telephone number, birth date, etc. are often collected directly. So is health status, so that Meda can provide you with information that is more likely to be relevant.

"Cookies". At times Meda, and at times advertisers on our websites, will employ the use of cookies. A "cookie" is a data file that a website may place on your computer’s hard drive. In general, cookies are used to simplify and improve your communication and interaction with a website. A website sponsor's ability to use a cookie to retrieve information from your computer can help customize the presentation of products and services, or help the website sponsor enhance their services to you. Some cookies are temporary and erased when you leave the Internet or shut down; others stay on your computer unless or until they are removed. If you do not wish to receive cookies from Meda websites, you can adjust your Web browser’s preferences on your computer. Please be aware that you can still visit our websites if you refuse cookies; but you may find that some of the features do not work, or do not work as well. Meda does not use cookies to retrieve information from your computer unless the information is related to our website or your interaction with our website.

Meda may use Google Analytics, a third party provider of analytics tools or a similar third party service to analyze information about visits to our website. For information about opting out of Google Analytics, please visit https://tools.google.com/dlpage/gaoptout.

Some Internet browsers offer what often is referred to as "do not track" mechanisms for browser users to automatically signal privacy preferences to websites that they visit. Internet browsers have only begun to include these features relatively recently. Our website(s) do not currently respond to do-not-track-signals. We may revisit the issue in the future. In the meantime, however, you can exercise other choices available, including limiting the placement of browser cookies on your device using your browser's cookie control features and other choices described in this Policy.

Web pixels. These are tiny graphics similar to cookies. Web pixels collect information that cannot be used to identify you personally such as the addresses of websites you view, the website that you viewed immediately prior to visiting our website, or the address of the website where the link used to reach our website was accessed. In addition, web pixels can be used to monitor whether email communications have been opened.

In general, Meda websites are not directed at children and most of the online services offered by Meda are designed for adults, age 18 or older.

Where available, you may update personal information by modifying information that was previously entered into either a Web form or data fields located within a Meda website. If you wish to access personal information collected by Meda, you may contact privacy@meda.us for purposes of ensuring accuracy or completeness of personal information. Please be aware that you may not always be able to access the information that has been collected. For instance, your ability to access and correct personal information will be limited where we believe it would interfere with our ability to fulfill legal or ethical obligations or to address legal claims. Access and correction of personal information will not be allowed if it would result in disclosure of a third party's personal information, or lead to a breach of contract or disclosure of trade secrets or other protected business information.

Meda strives to protect personal information as it is transmitted from your computer to our websites. Due to the open nature of the Internet, Meda cannot guarantee that our interactions with you, or your interactions with Meda, will be free from unauthorized access by third parties. Meda protects our servers and data with a firewall and endeavors to protect personal information within our possession, custody, or control from unauthorized access, disclosure, alteration or destruction. Employees and business partners with access to your personal information must have a business–related "need to know" in order to perform their job functions for Meda. However, Meda also depends upon you to help secure information by protecting your own copies of passwords and related access codes for our websites.

Personal information is accessible to Meda, including its subsidiaries, divisions and groups worldwide, and to individuals and organizations that use personal information solely for, and at the direction of, Meda. Uses and disclosures of personal information by external individuals and organizations acting on Meda's behalf are governed by agreements that require personal information to be protected appropriately. Personal information about you only will be used and disclosed by Meda and individuals and organizations working on its behalf, in a manner consistent with this Privacy Policy, other applicable privacy notices, and as explicitly permitted or required by applicable laws, rules and regulations.

In general, Meda does not sell or barter your personal information to third parties. However, if Meda decides to reorganize or divest its business through sale, merger or acquisition, it is possible that personal information will be shared with actual or prospective buyers. If that happens, Meda will obtain a written agreement that personal information will be properly protected. Except where explicitly permitted, required by law, or provided in this Privacy Policy, personal information will not otherwise be shared without your consent.

You will have some choices about whether and/or when to share personal information with Meda. In cases where you are affirmatively requested to provide information, such as to complete a form, a survey, or application on a Meda website, you may decline to do so. Please understand, however, that in some cases certain information is required to complete an application, form, or survey, and if you decline to provide the information requested, you may not be able to use certain functionalities of our websites.

In addition, you may be given additional choices in the context of particular preferences tools or functions that are made available through Meda’s websites or opportunities to opt-out of future email or other communications using the opt-out choices offered within those communications.

More Important Safety Information

Do not take more Edluar than prescribed.

Do not take Edluar unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
Take Edluar right before you get in bed, not sooner.

Edluar may cause serious side effects, including:
After taking Edluar, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you many not remember that you did anything during the night.

Reported activities include:

  • driving a car ("sleep-driving")
  • making and eating food
  • talking on the phone
  • having sex
  • sleepwalking

Call your healthcare provider right away if you find out that you have done any of the above activities after taking Edular.

Do not take Edluar if you:

  • drank alcohol that evening or before bed
  • took another medicine to help you sleep

Edluar is a class four (C-IV) federally controlled substance because it can be abused or lead to dependence.

Edluar may not be right for you. Before starting Edluar, tell your healthcare provider about all of your health conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts
  • have a history of drug or alcohol abuse or addiction
  • have kidney or liver disease
  • have lung disease or breathing problems
  • are pregnant or planning to become pregnant. It is not known if Edluar will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Edluar can pass into your breast milk. It is not known if Edluar will harm your baby. Talk to your healthcare provider about the best way to feed your baby while you take Edluar.

Medicines can interact with each other, sometimes causing serious side effects.

Do not take Edluar with other medicines that can make you sleepy, unless directed by your healthcare provider.

Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Do not take Edluar if you are allergic to zolpidem or any other ingredients in Edluar.

Do not take Edluar if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Zolpimist, or Intermezzo.

Do not take Edluar if you drank alcohol that evening or before bed.

Edluar may cause serious side effects, including:

  • getting out of bed while not being fully awake and doing an activity that you do not know you are doing.
  • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, suicidal thoughts or actions.
  • memory loss
  • anxiety
  • severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing. Get emergency medical help if you get these symptoms after taking Edluar.

The most common side effects of Edluar are:

  • drowsiness
  • dizziness
  • diarrhea
  • grogginess or feeling as if you have been drugged
  • fatigue
  • headache

Approved Uses

Edluar is a sedative-hypnotic (sleep) medicine. Edluar is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

It is not known if Edluar is safe and effective in children under the age of 18 years.

These are not all the side effects of Edluar. Ask your doctor or pharmacist for more information. You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please read the Medication Guide for Edluar and discuss it with your doctor.