IMPORTANT RISK INFORMATION
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WARNING TO WOMEN WHO SMOKE

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.

What is Lo Loestrin®Fe?

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. If you are moderately obese, discuss with your healthcare provider whether Lo Loestrin Fe is appropriate for you.

Who should not take Lo Loestrin Fe?

Do not use Lo Loestrin Fe if you have or have had blood clots, history of heart attack or stroke, high blood pressure that medicine cannot control, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, if you are or may be pregnant, or if you take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.

What else should I know about taking Lo Loestrin Fe?

Treatment with Lo Loestrin Fe should be stopped if you have a blood clot, and at least 4 weeks before and through 2 weeks after major surgery. You should not take Lo Loestrin Fe any earlier than 4 weeks after having a baby, or if you are breastfeeding. If you experience yellowing of the skin or eyes due to problems with your liver, you should stop taking Lo Loestrin Fe. If you are pre-diabetic or diabetic, your doctor should monitor you while using Lo Loestrin Fe. Your doctor should evaluate you if you have any significant change in headaches or irregular menstrual bleeding.

What are the most serious risks of taking Lo Loestrin Fe?

Lo Loestrin Fe increases the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability.

What are the possible side effects of Lo Loestrin Fe?

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 the full Prescribing Information, including Boxed Warning, and Patient Information.