Important Safety Information

The risks of serious cardiovascular side effects are substantially increased in women who smoke and use OCs, especially in women over age 35. Women who use oral contraceptives should be strongly advised not to smoke.

Contraindications

Combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders (current of past history), cerebrovascular or coronary artery disease (current of past history), valvular heart disease with thrombogenic complications, thrombogenic rhythm disorders, hereditary or acquired thrombophilias, major surgery with prolonged immobilization, diabetes with vascular involvement, headaches with focal neurological symptoms such as aura, uncontrolled hypertension, known or suspected carcinoma of the breast or personal history of breast cancer, carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior pill use, hepatic adenomas or carcinomas, or active liver disease, known or suspected pregnancy, hypersensitivity to any of the components of LYBREL.

• Oral contraceptives (OCs) do not protect against HIV infection or other sexually transmitted diseases.
• Serious risks associated with OCs include blood clots, heart attack, and stroke.
• LYBREL provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.
• Scheduled withdrawal bleeding does not occur with the use of LYBREL, therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy and as such, unexpected pregnancy may be difficult to recognize. Although pregnancy is unlikely if LYBREL is taken as directed, if for any reason, pregnancy is suspected in a woman using LYBREL, a pregnancy test should be performed.

Adverse Reactions

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives: Thromboembolic and thrombotic disorders and other vascular problems, carcinoma of the reproductive organs and breasts, hepatic neoplasia/liver disease, ocular lesions, gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The health information contained herein is provided for educational purposes only is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

The product information is intended only for residents of the United States.
The products discussed herein may have different product labeling in different countries.

LBE00012

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