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Duramed Pharmaceuticals, Inc. ("Duramed") respects your privacy, and the privacy of all visitors to its Web sites (the "Sites"). It is the company's policy to collect only personally identifiable information, such as names, addresses, telephone/fax numbers, or email addresses, when such information is voluntarily submitted by our visitors. This information will be kept strictly confidential and will not be sold, reused, rented, loaned, or otherwise disclosed, except as described in this privacy policy.
We will not disclose your information other than to our contractors, where necessary, to operate and maintain this Web site or as required by law or legal process.
We will only use the information we collect from you to answer any of your requests for information, such as to send you updates or other informational mailings you may find useful, or to better understand your needs.
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Cookies are small text files that are sent by a Web site, accepted by a Web browser, and then placed on your hard drive. Duramed Web sites may use cookies to collect data that help provide information regarding the functionality of the site or to help analyze browsing patterns and use of the site.
Children
The Sites are not intended or designed to attract children under the age of 18. Duramed does not collect personally identifiable data from any person we know to be under the age of 18.
Revisions to This Policy
Duramed reserves the right, at our discretion, to change, modify, add, or remove portions of this policy at any time. If we change our Privacy Policy, we will post those changes on this page so that you may become aware of what information we may collect, how we may use it, and under what circumstances we may disclose it. You should visit this page from time to time to review the then-current policy because it is binding on you. This Privacy Policy was last updated June 2003.
General
Links from these Sites may take you to sites not covered by this Privacy Policy, and we advise you to check the applicable privacy practices yourself.
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Prescribing Information View Prescribing Information [PDF–Size: 591KB] IMPORTANT SAFETY INFORMATION ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER CARDIOVASCULAR AND OTHER RISKS The Women's Health Initiative (WHI) study 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 years of treatment with oral conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated equine estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Other doses of oral conjugated estrogens with 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 individuals 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; hypersensitivity to its ingredients; 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 the clinical trial 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. Patients should be started at the lowest approved dose of 0.3 mg ENJUVIA daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider. |
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