INDICATION for Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)
Loestrin® 24 Fe is a prescription oral contraceptive used for the prevention of pregnancy.
IMPORTANT SAFETY INFORMATION about Loestrin® 24 Fe, 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.
For additional safety information, please see FDA-Approved Patient Labeling.
INDICATION AND USAGE for Minastrin® 24 Fe (norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets)
Minastrin® 24 Fe is a prescription birth control pill used for the prevention of pregnancy.
Take one tablet by mouth at the same time every day, in the order on the blister pack. The tablets should be chewed and swallowed. You should drink a full glass (8 ounces) of water immediately after swallowing.
Minastrin® 24 Fe (norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets) have been shown to be bioequivalent to Loestrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets).
IMPORTANT SAFETY INFORMATION about Minastrin® 24 Fe, including Boxed Warning
WARNING TO WOMEN WHO SMOKE
Do not use Minastrin® 24 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; a history of heart attack or stroke; certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart; inherited blood clotting disorders; high blood pressure that medicine can’t control; diabetes with kidney, eye, nerve, or blood vessel damage; certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headache if you are over age 35; breast cancer or any cancer that is sensitive to female hormones; liver disease or liver tumors; unexplained bleeding from the vagina; 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 if they are over 35 years of age. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. In a clinical study, the most common side effects reported by women were headache, vaginal infections, nausea, painful menstruation, breast tenderness, abnormal Pap smear, acne, mood swings, and weight gain.
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
Please click here for FDA-Approved Patient Labeling, also available at www.minastrin24.com.
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.