Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

Important Safety Information

  • You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of Lialda.
  • Reports of problems with kidney function have been associated with mesalamine-containing products like Lialda. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting Lialda and periodically while on therapy.

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Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

Important Safety Information

  • You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of Lialda.
  • Reports of problems with kidney function have been associated with mesalamine-containing products like Lialda. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting Lialda and periodically while on therapy.
Read more

Privacy Policy

This site is owned by Shire US Inc. This Online Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this site or that we acquire from your use of the site. Please be sure to read this entire Online Privacy Policy before using, or submitting information to, this site.

Your Consent

By using this Shire site, you signify your consent to the collection, use and disclosure of the information that you provide to the site or that we secure from your use of the site. If you do not agree to this policy, please do not use this site. We reserve the right, at our discretion and where permitted by law, to change, modify, add, or remove portions of this policy at any time with or without notice. Please check this page periodically for changes. Your continued use of our sites following the posting of changes to these terms will mean you accept those changes.

About Children

Generally, we do not knowingly collect information from children on this site. We encourage parents to talk to their children and supervise their use of the Internet and the information they disclose to Web sites.

In some cases, there are treatments that pertain to children, and while this site is not intended for use by minors, you may have the opportunity to provide personal information about a child. Such information will only be used to provide the requested services, and for no other purposes.

About This Site

In our effort to bring you up-to-date and accurate product and resource information, we use various expert sources and studies to develop site content. As a result, you may find slight differences in statistics and/or percentages across various articles—because different sources can view data differently.

Information We Collect and How We Collect It

You can visit our site and view most of the content anonymously; however, we may collect information from you.

The information we gather on our site falls into three categories: (1) personally identifiable information you supply, (2) aggregate information collected as you navigate through our site, and (3) publicly or commercially available information.

Personally Identifiable Information Collection

Like many Web sites, this site actively collects information from its visitors both by asking you specific questions (for example, such as a registration) and by permitting you to communicate directly with us via e-mail, feedback forms, and/or chat rooms. Some of the information that you submit may be personally identifiable information (that is, information that can be uniquely identified with you, such as your full name, address, e-mail address, phone number, and so on).

Some areas of this site may require you to submit treatment and/or demographic information in order for you to benefit from the specialized features (such as newsletter subscriptions, tips/pointers, etc.) or to participate in a particular activity (such as promotions). You will be informed at each information collection point what information is required and what information is optional.

Social Media: Generally, online social media resources are interactive tools that enable you to collaborate and share information with others. Social media resources include but are not limited to social networks, discussion boards, bulletin boards, blogs, wikis, and referral functions to share Web site content and tools with a friend or colleague. Shire may collect personal information from you to enable you to use online social media resources we may occasionally offer to you. Shire may also enable you to use these social media resources to post or share personal information with others. When using social media resources, you should take into careful consideration what information about yourself you choose to share with others. Shire provides additional notice and choices about how personal information is collected, used and disclosed on our Web sites and other online resources that offer social media.

Mobile Computing: In addition to the uses described above for the Shire Web sites, some Shire Web sites and online resources are specifically designed to be compatible and used on mobile computing devices. Mobile versions of Shire Web sites may require that you log in with a user account for that Web site. Information about your use of the mobile version of the Web site will be associated with your user account. Further, some of our Web sites and online resources may enable you to download an application, widget or other tool that you can use on your mobile or other computing device. Some of these tools may store information on your mobile or other device. These tools may transmit personal information to Shire to enable you to access your user account and to enable Shire to track use of these tools. Some of these tools may enable you to e-mail reports and other information from the tool. Shire may use personal or non-identifiable information transmitted to Shire to enhance these tools, to develop new tools, for quality improvement and as otherwise described in this Policy or in other notices Shire provides.

Other Information Collection

As you navigate through a Web site, certain information can be passively collected (that is, gathered without your actively providing the information) using various technologies and means, such as navigational data collection. This 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. We use your IP address to diagnose problems with our server, report aggregate non-personally identifiable information, determine the fastest route to your computer in connecting to our site, and administer and improve the site.

We also collect information about your use of our site through cookies and similar technology. A "cookie" is a bit of information that a Web site sends to your computer that helps the site remember information about you and your preferences and recognize you as a return visitor to the site. Cookies, by themselves, do not tell us your e-mail address or other personally identifiable information. However, we may combine this information with other information collected from or about you in order to help customize content.

"Web beacons" (also known as Internet tags, single-pixel GIFs/PNGs, clear GIFs/PNGs, invisible GIFs/PNGs, and 1-by-1 GIFs/PNGs) 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. This site may at times use Web Beacons.

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

Publicly/Commercially Available Information Collection

Publicly or commercially available information is defined as information that an individual makes or permits to be made available to the public, or is legally available through an independent list broker or other third party, and/or is legally obtained and accessed from, amongst other sources: government records that are available to the public, journalistic reports, or information that is required by law to be available. We may collect publicly available information or purchase commercially available information about you from third parties.

Use and Disclosure of Information

Except as otherwise stated, we may use your information 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, to respond to access requests or to otherwise protect Shire's legal and business interests and rights, and for the other purposes specified in this Online Privacy Policy. If you provide personally identifiable information to this site, we may combine such information with other actively and passively collected information.

We may disclose your personally identifiable information to our affiliates worldwide that agree to treat it in accordance with this Online Privacy Policy. In addition, we may disclose your personally identifiable information to third parties located in countries outside of the one in which you reside that may have laws and regulations different than your own, but only (i) to contractors we use to support our business (e.g., fulfillment services, technical support, delivery services, market research providers, and financial institutions), in which case we will require such third parties to agree to treat it in accordance with this Online Privacy Policy; or (ii) where required by applicable laws, court orders, or government regulations; or (iii) to otherwise protect Shire's legal and business interests.

Length of Personal Information Retention

Personal information will be stored as long as the information is required to fulfill Shire's legitimate business needs or the purposes for which the information was collected, or until an individual whose data is involved requests that we delete that information (unless its retention is required by law).

Access and Correction

To keep your personally identifiable information accurate, current and complete, please contact us as specified below. We will take reasonable steps to update or correct or to remove personally identifiable information in our possession that you have previously submitted via this site or that we have acquired from other sources.

Security

We take commercially reasonable steps to protect your personally identifiable information as you transmit your information from your computer to our site and to protect such information from loss, misuse, unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from this site may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail. Moreover, where you use passwords, ID numbers, or other special access features on this site, it is your responsibility to safeguard them.

Notification Procedures

In the event of an incident or security breach resulting in your personally identifiable information being accessed, lost, or stolen by an unauthorized third party, Shire will exercise commercially reasonable efforts to (i) notify you to the extent required by law; and (ii) identify the personally identifiable information that was accessed/disclosed using the contact information you have provided to us or by any other reasonable means.

Links to Other Web Sites

This site may contain links or references to other Web sites. Please be aware that Shire does not control other Web sites and that this Online Privacy Policy does not apply to those Web sites. We encourage you to read the privacy policy of every Web site you visit. We are not responsible for, nor do we endorse, the contents of these other Web sites. If you in any way rely on information obtained from any such Web sites, you do so at your own risk.

How to Contact Us / Accountability

If you have any questions, comments or concerns about this Online Privacy Policy or about the information practices of this site, or would like to have your information removed from our files, please contact us as follows:

Shire US Inc.
Attn: Online Privacy Policy
725 Chesterbrook Blvd
Wayne, PA 19087

This policy was last revised June 1, 2011

Important Safety Information (cont'd)

  • Products that contain mesalamine, like Lialda, have been associated with a condition that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach ache, bloody diarrhea, fever, headache, and rash. If you experience any of these symptoms, talk to your doctor immediately. Your doctor may decide to discontinue your medication.
  • Tell your doctor if you are allergic to sulfasalazine, as you may also be allergic to Lialda or drugs that contain or are converted to mesalamine. Some patients taking Lialda or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart. Tell your doctor if you have or have had a history of myocarditis or pericarditis as this may increase your likelihood of having these types of reactions.
  • Reports of liver failure have been associated with mesalamine-containing products like Lialda in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.
  • Tell your doctor if you have a stomach blockage, as this may delay the release of medication.
  • In clinical trials, common side effects reported with Lialda included ulcerative colitis, headache, gas, abnormal liver function test results, and stomach ache. Inflammation of the pancreas was reported which led to discontinuation of Lialda therapy. Other side effects may occur.
  • Before starting Lialda, tell your doctor about all medications you are taking. Mesalamine may increase the risk of kidney problems when used with non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen). Mesalamine may increase the risk of blood disorders when used with azathioprine and 6-mercaptopurine.

Please see 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.

 
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