LO LO ESTRIN ® FE
YOUR QUESTIONS ANSWERED

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

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

ABOUT LO LOESTRIN FE

GETTING LO LOESTRIN FE

TAKING LO LOESTRIN FE

SIDE EFFECTS

MY PERIOD ON LO LOESTRIN FE

IRREGULAR BLEEDING

ABOUT

What is Lo Loestrin® Fe?

Lo Loestrin Fe is a low-dose birth control pill that contains 2 types of female hormones, an estrogen called ethinyl estradiol and a progestin called norethindrone acetate. When taken as directed, oral contraceptives help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

How effective is Lo Loestrin Fe?

Lo Loestrin Fe is effective at preventing pregnancy. Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Women with a body mass index (BMI) above 35 kg/m 2 were not studied in the clinical trial, so it is not known how well Lo Loestrin Fe protects against pregnancy in such women. If you are moderately obese, discuss with your healthcare provider whether Lo Loestrin Fe is appropriate for you.

GETTING LO LOESTRIN FE

How can I get Lo Loestrin Fe?

Lo Loestrin Fe is a prescription birth control pill—you need to visit your healthcare provider to make sure it’s the right option for you. There’s no generic equivalent available, so be sure your pharmacy fills your Lo Loestrin Fe prescription as prescribed.

TAKING LO LOESTRIN FE

Who should not take Lo Loestrin Fe?

You should not take oral contraceptives 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.

Birth control pills should not be taken during pregnancy.

You should not take Lo Loestrin Fe any earlier than 4 weeks after having a baby.

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Lo Loestrin Fe, may decrease the amount of breast milk your body makes. A small amount of the Pill’s hormones pass into breast milk.

Your healthcare provider will not give you Lo Loestrin Fe if you have ever had breast cancer, liver disease including liver tumors, blood clots in your legs, lungs, or eyes, a stroke, heart attack, certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart, an inherited problem with your blood that makes it clot more than normal, high blood pressure that medicine can’t control, diabetes with kidney, eye, nerve, or blood vessel damage, or certain kinds of severe migraines with aura, numbness, weakness, or changes in vision. Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy).

Your healthcare provider also will not give you Lo Loestrin Fe if you are taking Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.

Can I take Lo Loestrin Fe with my other medications?

Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control less effective, including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St John’s wort, and topiramate.

How do I take Lo Loestrin Fe?

Take 1 pill at the same time every day. Take the pills in the order directed on the blister pack. Do not skip pills or take at intervals exceeding 24 hours. If you miss any pills or if you vomit or have diarrhea within 3 to 4 hours after taking your pill, follow the instructions for " What should I do if I miss any pills? "

When can I start taking Lo Loestrin Fe?

Talk to your healthcare provider about which day is best for you to start taking Lo Loestrin Fe. It is important to take your birth control pill at the same time every day and in the order directed on the blister pack.

If you are starting a hormonal birth control pill for the first time:

  1. Take the first blue pill of the first pack during the first 24 hours of your period.
  2. You will not need to use a back-up method of birth control because you are starting the pill at the beginning of your period. However, if you start on a day other than the first day of your period, or if you start after having a baby and you have not yet had a period, use a back-up method of birth control, such as a condom and spermicide, until you have taken a blue pill for 7 days in a row.
  3. After taking the last brown pill (Day 28) of the blister pack, start taking the blue pill from a new blister pack the very next day whether or not you have your period. You should not skip any days between packs. Learn more about starting or switching to Lo Loestrin Fe.
What if I want to become pregnant?

You may stop taking Lo Loestrin Fe whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking Lo Loestrin Fe.

SIDE EFFECTS

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

Like pregnancy, 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.

What are the most common 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.

Does Lo Loestrin Fe affect weight or cause anxiety or depression?

In a clinical study, about 4% of women reported changes in weight and 2% reported anxiety or depression when taking Lo Loestrin Fe. Women with a history of depression should be carefully observed by their healthcare provider and if depression comes back to a serious degree, Lo Loestrin Fe should be discontinued.

The most common side effects reported by women taking Lo Loestrin Fe in a study were nausea/vomiting (7%), headache (7%), spotting or bleeding between menstrual periods (5%), painful menstruation (4%), weight change (4%), breast tenderness (4%), acne (3%), abdominal pain (3%), anxiety (2%), and depression (2%).

MY PERIOD ON LO LOESTRIN FE

What should I know about my period when taking Lo Loestrin Fe?

When you take Lo Loestrin Fe you may have bleeding and spotting between periods, called unscheduled bleeding. Approximately half of the women who use Lo Loestrin Fe have unscheduled bleeding or spotting in the first months of use, and about one-third of users continue to have unscheduled bleeding or spotting after one year of use. If the unscheduled bleeding or spotting is heavy, or lasts for more than a few days, you should discuss this with your healthcare provider.

What if I miss my scheduled period when taking Lo Loestrin Fe?

It is not uncommon to miss your period. However, if you go two or more months in a row without a period, or you miss your period after a month where you did not take all your pills correctly, call your healthcare provider because you may be pregnant. Also notify your healthcare provider if you have symptoms of pregnancy, such as morning sickness or unusual breast tenderness. Stop taking Lo Loestrin Fe if you are pregnant.

What should I do if I miss any pills?

Your birth control pills may not be as effective if you miss any blue or white pills, especially if you miss the first few or the last few blue pills in a pack.

If you MISS 1 blue pill:

If you MISS 2 blue pills in a row in WEEK 1 or WEEK 2 of your pack:

If you MISS 2 blue or white pills in a row in WEEK 3 or WEEK 4 of your pack:

If you MISS 3 or MORE blue or white pills in a row at any time:

If you are not sure of what to do about the pills you have missed, you should call your healthcare provider. Use a back-up method of birth control, such as a condom and spermicide, any time you have sex, and keep taking 1 pill each day until you reach your healthcare provider.

IRREGULAR BLEEDING

Is it normal to have spotting while on the pill?

Yes, it's normal. Spotting, also called irregular bleeding or breakthrough bleeding, typically happens during the first few months of taking a new birth control pill. It may take time for your body to adjust to the new hormone levels.

Approximately half of the women who use Lo Loestrin Fe have unscheduled bleeding (bleeding or spotting between periods) in the first months of use, and about one-third of users continue to have unscheduled bleeding or spotting after one year of use. If the unscheduled bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider.

IMPORTANT RISK INFORMATION

What is Lo Loestrin ® Fe?

Lo Loestrin Fe 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.

IMPORTANT RISK INFORMATION

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.

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, liver disease or liver tumors, unexplained bleeding from the vagina, 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 prediabetic 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. Lo Loestrin Fe should not be taken during pregnancy.

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.

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.

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