Loestrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) is a prescription oral contraceptive used for the prevention of pregnancy.
IMPORTANT SAFETY INFORMATION about Loestrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), including Boxed Warning
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.
The use of combination oral contraceptives is associated with increased risks of several serious side effects, which can be life threatening, including blood clots, stroke or heart attack. Some women should not use the Pill, including women who have or have had blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
The most common side effects reported by Loestrin® 24 Fe users were headache, vaginal infections, and upper respiratory infection.
Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Please see Full Prescribing Information, which includes the Patient Information and Boxed Warning.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is a prescription birth control pill used for the prevention of pregnancy.
IMPORTANT SAFETY INFORMATION about Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets), including Boxed Warning
Do not use Lo Loestrin® Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
You should not use birth control pills if you have or have had blood clots; breast cancer or any cancer that is sensitive to female hormones; a history of heart attack or stroke; high blood pressure that medicine can’t control; diabetes with kidney, eye, nerve, or blood vessel damage; liver disease or liver tumors; certain kinds of severe migraine headaches; jaundice (yellowing of the skin or eyes) caused by pregnancy; or if you are or may be pregnant.
Birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. The most common side effects reported by women taking Lo Loestrin® Fe in a study were nausea/vomiting, headache, spotting or bleeding between menstrual periods, painful menstruation, weight change, breast tenderness, acne, abdominal pain, anxiety, and depression.
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
Please see Full Prescribing Information, which includes the Patient Information and Boxed Warning.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Visit www.loloestrin.com for more information.
Loestrin® and Lo Loestrin® are registered trademarks of Warner Chilcott Company, LLC.