SAFETY INFORMATIONWomen who use oral contraceptives (OCs) should be strongly advised not to smoke due to the increased risk of cardiovascular side effects. Serious risks reported with the use of OCs include blood clots, stroke, and heart attacks. OCs are contraindicated in women with thrombophlebitis, thromboembolic disorders, breast cancer, hepatic or estrogen-dependent neoplasia, cerebrovascular or coronary artery disease, jaundice, or undiagnosed genital bleeding. OCs do not protect against HIV infection (AIDS) or other sexually transmitted diseases.
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Based on the results of open-label, randomized pharmacokinetic studies repeated at intervals of at least 4 weeks.
Reference: 1. Data on file, Watson Pharma, Inc.