Levonorgestrel/ ethinyl estradiol

Generic Name: levonorgestrel/ethinyl estradiol (LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol & FOE-late)
Brand Name: Falessa Kit

Smoking cigarettes while using levonorgestrel/ethinyl estradiol increases your chance of having heart problems. Do not smoke while using levonorgestrel/ethinyl estradiol. The risk of heart problems increases with age and with frequent smoking. Women older than 35 years old and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems.


Levonorgestrel/ ethinyl estradiol is used for:

Preventing pregnancy. It may be used for other conditions as determined by your doctor.

Levonorgestrel/ethinyl estradiol is a combination birth control pill and folate supplement kit. The birth control pill works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus. The folate supplement works by improving nutrition status.

Do NOT use levonorgestrel/ ethinyl estradiol if:

  • you are allergic to any ingredient in levonorgestrel/ethinyl estradiol
  • you are pregnant or think you may be pregnant
  • you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or breast cancer
  • you are at risk for developing severe blood clots or have certain heart problems (eg, certain heart valve problems, certain types of irregular heartbeat)
  • you have chest pain caused by angina; certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; or undiagnosed abnormal vaginal bleeding; or diabetes that affects circulation
  • you have liver disease, liver tumors or cancer, or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use
  • you have had surgery and are or will be confined to a bed or a chair for an extended period of time
  • you are older than 35 years old and you smoke 15 or more cigarettes per day

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using levonorgestrel/ ethinyl estradiol:

Some medical conditions may interact with levonorgestrel/ethinyl estradiol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, heart problems, diabetes, headaches or migraines, gallbladder problems, high blood cholesterol or lipid levels, high blood pressure, kidney problems, blood problems (eg, porphyria), blood in the urine, depression or other mental/mood problems, lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), seizures (eg, epilepsy), or a history of cancer
  • if you are overweight, you have not yet had your first menstrual period, or you use tobacco
  • if you have given birth or otherwise ended a pregnancy within the past 4 weeks

Some MEDICINES MAY INTERACT with levonorgestrel/ethinyl estradiol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Atorvastatin, indinavir, or troleandomycin because they may increase the risk of levonorgestrel/ethinyl estradiol's side effects
  • Aprepitant, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, primidone, rifabutin, rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease levonorgestrel/ethinyl estradiol's effectiveness, resulting in breakthrough bleeding or pregnancy
  • Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, or theophylline because the risk of their side effects may be increased by levonorgestrel/ethinyl estradiol
  • Clofibric acid, lamotrigine, morphine, salicylic acid, or temazepam because their effectiveness may be decreased by levonorgestrel/ethinyl estradiol

This may not be a complete list of all interactions that may occur. Ask your health care provider if levonorgestrel/ethinyl estradiol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use levonorgestrel/ ethinyl estradiol:

Use levonorgestrel/ethinyl estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with levonorgestrel/ethinyl estradiol. Talk to your pharmacist if you have questions about this information.
  • Take levonorgestrel/ethinyl estradiol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Begin taking levonorgestrel/ethinyl estradiol on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking levonorgestrel/ethinyl estradiol on that day. Try to take levonorgestrel/ethinyl estradiol at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
  • For levonorgestrel/ethinyl estradiol to be effective it must be taken every day. Do not skip doses.
  • If you miss a dose of levonorgestrel/ethinyl estradiol and remember it on the same day, take it as soon as possible and go back to your regular dosing schedule. If you do not remember until the next day or if you miss more than 1 dose of levonorgestrel/ethinyl estradiol, see the additional patient information leaflet that comes with levonorgestrel/ethinyl estradiol or contact your doctor for further instructions. You may need to use an extra form of birth control (eg, condoms). If you are not sure about how to handle missed doses of levonorgestrel/ethinyl estradiol, use an extra form of birth control (eg, condoms) until you talk with your doctor.

Ask your health care provider any questions you may have about how to use levonorgestrel/ethinyl estradiol.

Important safety information:

  • Levonorgestrel/ethinyl estradiol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use levonorgestrel/ethinyl estradiol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.
  • If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking levonorgestrel/ethinyl estradiol.
  • You should usually not take levonorgestrel/ethinyl estradiol within 4 weeks after giving birth or otherwise ending a pregnancy. Discuss any questions or concerns with your doctor.
  • Levonorgestrel/ethinyl estradiol may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
  • Use of levonorgestrel/ethinyl estradiol will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).
  • Bleeding or spotting may occur while taking levonorgestrel/ethinyl estradiol. Do not stop taking levonorgestrel/ethinyl estradiol if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
  • Smoking while using levonorgestrel/ethinyl estradiol may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.
  • Levonorgestrel/ethinyl estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using levonorgestrel/ethinyl estradiol.
  • Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using levonorgestrel/ethinyl estradiol may decrease the effectiveness of levonorgestrel/ethinyl estradiol. To prevent pregnancy, use an extra form of birth control (eg, condoms) until your next period.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.
  • Levonorgestrel/ethinyl estradiol may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping levonorgestrel/ethinyl estradiol. Discuss any concerns with your doctor or pharmacist.
  • Lab tests, such as PAP tests, may be performed while you use levonorgestrel/ethinyl estradiol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Levonorgestrel/ethinyl estradiol should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY AND BREAST-FEEDING: Do not use levonorgestrel/ethinyl estradiol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Levonorgestrel/ethinyl estradiol is found in breast milk. Do not breast-feed while taking levonorgestrel/ethinyl estradiol.

Possible side effects of levonorgestrel/ ethinyl estradiol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; breast tenderness or enlargement; changes in appetite; changes in sexual interest; changes in weight; dizziness; hair loss; headache; nausea; stomach cramps or bloating; unusual spotting or bleeding; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in amount of urine produced; change in vaginal secretions; changes in vision or speech; confusion; coughing of blood; crushing chest pain or heaviness in the chest; dark-colored urine; depression; difficulty sleeping; difficulty wearing contact lenses; fainting; fluid retention (swelling of the fingers and ankles); lack of energy; light-colored bowel movements; mental or mood changes; missed menstrual period; numbness of an arm or leg; one-sided weakness; persistent headache or migraines; persistent or recurrent abnormal vaginal bleeding; persistent or severe dizziness; severe pain or tenderness in the stomach; shortness of breath; sudden partial or complete loss of vision; sudden severe headache or vomiting; tiredness; vaginal irritation or discharge; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of levonorgestrel/ethinyl estradiol:

Store levonorgestrel/ethinyl estradiol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep levonorgestrel/ethinyl estradiol out of the reach of children and away from pets.

General information:

  • If you have any questions about levonorgestrel/ethinyl estradiol, please talk with your doctor, pharmacist, or other health care provider.
  • Levonorgestrel/ethinyl estradiol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take levonorgestrel/ethinyl estradiol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about levonorgestrel/ethinyl estradiol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to levonorgestrel/ethinyl estradiol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using levonorgestrel/ethinyl estradiol.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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