Prescribing Information

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Important Safety Information

  • The Pill does not protect against HIV or other sexually transmitted diseases.

  • Unscheduled bleeding or spotting is likely to occur while you are taking LYBREL. The convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned breakthrough bleeding and spotting.

  • Some women should not use the Pill, including women who have blood clots; breast, uterine, or liver cancers; a history of heart attack, stroke, or breast cancer; as well as those who are or may be pregnant.

  • Serious risks associated with the Pill which can be life threatening, include blood clots, stroke, and heart attacks and are increased if you smoke cigarettes.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use, especially if you are over 35. Women who use the Pill are strongly advised not to smoke.

  • 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.

  • Because regular monthly bleeding does not occur on LYBREL, it may be difficult to recognize if you get pregnant. If you suspect that you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, you should have a pregnancy test and you should contact your health care professional.

  • The most common side effects reported with LYBREL in a clinical trial were headache, menstrual cramps, upper respiratory infection, vaginal bleeding, and nausea.