ethinyl estradiol, folic acid, and levonorgestrel

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Pronunciation: ETH in il ESS tra DYE ol, FOE lik AS id, LEE voe nor JES trel

Brand: FaLessa Kit

What is the most important information I should know about birth control pills?

Do not use birth control pills if you are pregnant or think you might be pregnant.

You should not take birth control pills if you have uncontrolled high blood pressure, certain heart problems, a history of heart attack or stroke, circulation problems, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or if you have ever had a blood clot, jaundice caused by birth control pills, or cancer of the breast, uterus, or cervix.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take birth control pills if you smoke and are over 35 years old.

What is ethinyl estradiol, folic acid, and levonorgestrel?

Ethinyl estradiol and levonorgestrel prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Folic acid is a type of B vitamin that helps prevent a rare birth defect that could occur in a baby if you get pregnant while taking birth control pills or shortly after stopping them.

Ethinyl estradiol, folic acid, and levonorgestrel is a combination drug used to prevent pregnancy.

Ethinyl estradiol, folic acid, and levonorgestrel may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking birth control pills?

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use if you are pregnant or think you might be pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

  • untreated or uncontrolled high blood pressure;
  • heart disease (angina, coronary artery disease, rhythm disorder, uncontrolled heart valve disorder) or history of heart attack, stroke, or blood clot);
  • circulation problems caused by diabetes;
  • past or present cancer of the breast, uterus, or cervix;
  • unusual vaginal bleeding that has not been checked by a doctor;
  • liver disease or liver cancer;
  • severe migraine headaches; or
  • a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take birth control pills, tell your doctor if you have:

  • heart problems, high blood pressure, high cholesterol;
  • a blood-clotting disorder;
  • history of depression or migraine headaches;
  • liver or kidney disease;
  • diabetes, gallbladder disease;
  • seizures or epilepsy; or
  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. You should not breast-feed while using this medicine.

This medicine is not approved for use by anyone younger than 16 or older than 65. Birth control pills are not approved for use by a girl who has not yet started having periods.

How should I take birth control pills?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. The package contains 21 "active" and 7 "reminder" pills, along with 28 folic acid tablets.

Take one pill and one folic acid tablet every day, every 24 hours. You may get pregnant if you do not take one pill daily. When the pills run out, start a new pack the following day.

You may have breakthrough bleeding, especially during the first 3 months. Call your doctor if this bleeding continues or is very heavy.

You may need to use back-up birth control (such as condoms or spermicide) when you first start using this medicine, or if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Follow the patient instructions provided with your medicine. Missing a pill increases your risk of becoming pregnant. If you miss one active pill, take it as soon as you remember. Then take one pill per day on your regular schedule for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day. Use back-up birth control for at least 7 days after you start the new pack.

If you miss three or more active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day. Use a nonhormonal birth control (condom, diaphragm with spermicide) for at least 7 days after you start the new pack.

If you miss a period for two months in a row, call your doctor because you might be pregnant. If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking birth control pills?

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Do not use other folic acid supplements unless your doctor tells you to.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

After you have stopped taking birth control pills, avoid becoming pregnant until you start having normal regular periods again.

What are the possible side effects of birth control pills?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot --chest pain, sudden cough, wheezing, coughing up blood, swelling or warmth in one or both legs;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • vision changes;
  • a change in the pattern or severity of migraine headaches;
  • swelling in your hands, ankles, or feet;
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes); or
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • light vaginal bleeding or spotting;
  • problems with contact lenses;
  • weight gain; or
  • acne or other skin changes, increased hair growth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect birth control pills?

Some drugs can make birth control pills less effective, which may result in pregnancy. Other drugs may be affected by birth control pills. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ethinyl estradiol, folic acid, and levonorgestrel. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol, folic acid, and levonorgestrel.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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