Introduction
Your privacy is important to us. To better protect that privacy, Teva Women’s Health, Inc., (“Teva”) is providing this notice to explain our online information practices and the choices you can make about the way your information is collected and used. This Privacy Policy applies only to the use and collection of data collected by the Web site located at www.tevawomenshealth.com (the “Web site”) and does not apply to any other data collected by Teva online or offline. This Web site is intended for use by residents of the United States.
As used in this Privacy Policy, “we” or “our” includes Teva and its affiliated companies as well as any third-party vendors we hire to assist in the administration of the Web site. These vendors are required to maintain the confidentiality of the user information to which they become privy in accordance with the terms of this Privacy Policy and to otherwise abide by the terms of this Privacy Policy. These vendors are prohibited from using the user information for any other purpose.
Collection and Use of Your Information
You can visit our Web site and find out about Teva’s products and services without giving us any personally identifiable information about you. When you visit our Web site, we do not collect any personally identifiable information without your consent. We collect and store information from you that you voluntarily choose to give us or enter on our Web site(s), including, but not limited to, personally identifiable information such as your name, address, e-mail address, etc. Our primary purpose in collecting and processing such information is to provide you with services that you request or to personalize product information for you. We may also use your personally identifiable information to provide you with additional information about our products and services. We may also share your personally identifiable information with our agents, contractors, or business partners, in order that they may perform services for us, but those businesses are under an obligation to maintain the privacy of your information consistent with this Privacy Policy.
While the information you provide will be maintained for a commercially reasonable time by Teva for administrative, liability, and archival purposes, your personally identifiable information is not shared with a third party, other than (i) as required by law, (ii) to protect and defend the rights of Teva or its affiliates, the Web site, or the users of the Web site, (iii) as incident to a corporate sale, merger, reorganization, dissolution, bankruptcy, or similar event, (iv) under circumstances we believe reasonably necessary to protect the personal safety of users of Teva products and services, the Web site, or the public, or (v) as is otherwise described in this Privacy Policy.
We do conduct research on a user’s demographics, interests, and behaviors based upon information provided to us during use of our Web site(s), and we may combine your information with information collected from other individuals to produce anonymous, aggregated statistical information. Aggregated data do not include personally identifiable information. We use this demographic information, such as the percentage of male or female visitors, or the percentage of visitors within certain age brackets, to improve the content of our site. We also may share this anonymous, aggregated information, which does not identify personally identifiable information, with third parties.
Security and Use of Information
To prevent unauthorized access to the Web site or any portion thereof, maintain data accuracy, and ensure the correct use of information, we have enacted commercially reasonable physical, electronic, and managerial procedures to safeguard and secure, during transmission and storage, the information we collect online. You should keep in mind that no Internet transmission is completely secure or error free. In particular, e-mail sent to or from this Web site may not be secure.
Special Note Regarding Web Site Use by Children
The Web site is neither directed at nor designed for use by children—ie, anyone under 18 years old. This Web site is neither directed at, nor designed for use by, children under 13 years old.
Links to Other Sites
As a resource to our visitors, Teva provides links to other Web sites. Please be aware that these other Web sites are not covered under Teva’s Privacy Policy. We suggest that when linking to another site, you always read that Web site’s privacy policy before volunteering any personally identifiable information.
Cookies and IP Addresses
Cookies are text files that are stored on a Web site user’s computer by the Web site. Cookies typically contain user-related information such as preferences, status, settings, etc. The purpose of most cookies is to make use of the Internet easier and quicker. Most browsers allow the user to choose settings that allow the use of cookies that provide notice to the user when cookies are being stored and/or that refuse all cookies.
An IP address is a unique identifying number that is automatically assigned to any computer connected to the Internet. Depending on the nature of your Internet connection, the IP address may change each time you connect or may always be the same number for that computer. We reserve the right to log IP addresses for system administration, security, statistical analysis, demographic analysis of Web site use, and other such functions.
Public Forums
To the extent that the Web site makes forums, message boards, and/or news groups available to you, please remember that any information that is disclosed in these areas becomes public information. You should exercise caution in disclosing personally identifiable information there or in any other public section of the Internet.
Changes to This Privacy Policy
Teva may, from time to time in its sole discretion, change or modify this Privacy Policy. Any changes or modification will be effective upon posting of the revisions on the Web site. At any given time, your access and use of the Web site and provision of information is governed by the Privacy Policy then in effect. Teva may post changes or modifications to referenced policies and guidelines without your approval, and may determine whether and when any such changes apply to you. Your continued use of the Web site following Teva’s posting of any changes or modifications will constitute your acceptance of such changes or modifications. Should you not wish to be bound by the modified Privacy Policy, you may not use or access the Web site.
Feedback
Comments, suggestions, or other communications sent by you to us are deemed to be non-confidential. We have no obligations of any kind in relation to such comments, suggestions, or communications and are free to use or distribute them in any way, including in relation to the administration, update, or improvement of the Web site, without compensation to the author, sender, or any other party.
By using the Web site, you signify your assent to this Privacy Policy. Should you have any privacy-related or compliance-related questions or concerns, you may contact us at 888 TEVA USA (838.2872). To keep personal information about you that we collected online accurate, complete, and current, you may contact the Teva Women’s Health Marketing Director at 201.930.3300. Where offered, you also may update personal information about you online by modifying information that you previously have entered into forms or data fields on the Web site.
IMPORTANT SAFETY INFORMATION
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.
The estrogen alone substudy of the Women’s Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo.
The estrogen-plus-progestin substudy of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo.
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Other doses of oral conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
ENJUVIA® tablets should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active or recent (eg, within the past year) arterial thromboembolic disease (eg, stroke, myocardial infarction); liver dysfunction or disease; known hypersensitivity to the ingredients of ENJUVIA® tablets; or known or suspected pregnancy. There is no indication for ENJUVIA® in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.
The most common side effects in clinical trials were headache, pain, nausea, and breast pain.
In a clinical trial, adverse events that occurred at a rate greater than or equal to 5% and greater than placebo, regardless of relationship to study drug, included: headache, breast pain, nausea, pain, flu syndrome, bronchitis, rhinitis, sinusitis, abdominal pain, accidental injury, flatulence, vaginitis, dizziness, paresthesia, and dysmenorrhea.
ENJUVIA® tablets are taken orally, once daily, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the treatment of moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause.
When prescribing solely for the treatment of moderate-to-severe vaginal dryness and pain during intercourse, topical vaginal products should be considered. Patients should be started at the lowest approved dose of 0.3 mg ENJUVIA® daily. Dosage should be periodically reassessed by the healthcare provider and adjustments made based upon the individual patient response.
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