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All about: Levonorgestrel/Ethinyl Estradiol

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Generic Name: Levonorgestrel/Ethinyl Estradiol Tablets 28-Day Pack (Continuous) (lee-voe-nor-JES-trel/ETH-i-nil es-tra-DYE-ol)
Brand Name: Lybrel

Smoking cigarettes while using Levonorgestrel/Ethinyl Estradiol increases your chance of having serious 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 progesterone and estrogen combination birth control pill. It works by preventing ovulation, thickening the mucus in the cervix, and changing the lining of the uterus.

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 have certain heart problems (eg, heart valve problems, certain types of irregular heartbeat); chest pain caused by angina; certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; diabetes that affects circulation; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; or undiagnosed abnormal vaginal bleeding
  • you have liver disease or liver tumors, 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 chair for an extended period of time

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

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 a history of endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
  • if you have a history of diabetes or high blood sugar, gallbladder problems, migraines or severe or persistent headaches, heart problems, high blood pressure, high blood cholesterol or lipid levels, kidney or liver problems, blood or bleeding problems, blood in the urine, mental or mood problems (eg, depression), high blood calcium levels, yellowing of the eyes or skin, pancreas problems, or seizures
  • if you have chorea (jerky, involuntary movements of the face, arms, or legs), lupus, porphyria (a certain blood problem), or varicose veins
  • if you are overweight, have swelling problems, you have not yet had your first menstrual period, or you smoke or use tobacco

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:

  • Troleandomycin because the risk of serious liver problems may be increased
  • Azole antifungals (eg, ketoconazole) because they may decrease Levonorgestrel/Ethinyl Estradiol 's effectiveness or increase the risk of Levonorgestrel/Ethinyl Estradiol 's side effects
  • Aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, ampicillin), 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), theophylline, or tizanidine because the risk of their side effects may be increased by Levonorgestrel/Ethinyl Estradiol
  • Lamotrigine because its 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.
  • Do not remove the tablet from the blister packaging until you are ready to take Levonorgestrel/Ethinyl Estradiol .
  • Begin taking Levonorgestrel/Ethinyl Estradiol during the first 24 hours of your period, unless your doctor tells you otherwise
  • If you are switching from another form of hormonal birth control to Levonorgestrel/Ethinyl Estradiol , be sure you know when you should start taking Levonorgestrel/Ethinyl Estradiol . Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to Levonorgestrel/Ethinyl Estradiol .
  • 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, even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
  • If you vomit within 4 hours after taking Levonorgestrel/Ethinyl Estradiol , follow the directions for what to do if you miss a pill.
  • If you miss 1 dose of Levonorgestrel/Ethinyl Estradiol , take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Levonorgestrel/Ethinyl Estradiol , read the extra patient information leaflet that comes with Levonorgestrel/Ethinyl Estradiol or contact your doctor for instructions. If you miss one or more doses of Levonorgestrel/Ethinyl Estradiol , you must use a backup form of birth control for 7 days after you start to take it again. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and 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.
  • Levonorgestrel/Ethinyl Estradiol may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke. Do not smoke or use other tobacco products while taking Levonorgestrel/Ethinyl Estradiol .
  • You could become pregnant if you miss 1 or more doses of Levonorgestrel/Ethinyl Estradiol . You could also become pregnant if you start the pack later than the proper day. If you have sex, you must use another form of birth control as a backup (eg, condoms) during the days that you miss doses and for the first 7 days after you begin to take it again. Talk with you doctor for more information or if you have trouble remembering to take Levonorgestrel/Ethinyl Estradiol .
  • If you experience unusual breast tenderness, symptoms of morning sickness, or any other symptoms of pregnancy, call your doctor right away.
  • 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.
  • The effectiveness of Levonorgestrel/Ethinyl Estradiol may be decreased by certain conditions (eg, vomiting, diarrhea) or medicines (eg, antibiotics, medicines for seizures, St. John's wort). This could cause breakthrough bleeding or increase the risk of an unplanned pregnancy if you have sex. To prevent pregnancy, use an extra form of birth control (eg, condoms). Talk with your doctor or pharmacist for more information.
  • Tell your doctor or dentist that you take Levonorgestrel/Ethinyl Estradiol before you receive any medical or dental care, emergency care, or surgery. If possible, Levonorgestrel/Ethinyl Estradiol should be stopped at least 4 weeks before and for 2 weeks after surgery or any time you might be confined to a bed or chair for a long period of time (such as a long plane flight, bedrest, or lengthy illness).
  • You should usually not start taking Levonorgestrel/Ethinyl Estradiol within 4 weeks after giving birth. Discuss any questions or concerns with your doctor.
  • If you wear contact lenses and you develop problems with them or with your vision, contact your doctor as soon as possible.
  • Levonorgestrel/Ethinyl Estradiol may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to Levonorgestrel/Ethinyl Estradiol . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • You may experience a delay in being able to become pregnant after stopping Levonorgestrel/Ethinyl Estradiol . This effect may be greater in patients who had irregular periods before starting Levonorgestrel/Ethinyl Estradiol . Discuss any concerns with your doctor or pharmacist.
  • Levonorgestrel/Ethinyl Estradiol does not stop the spread of HIV and other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
  • Diabetes patients - Levonorgestrel/Ethinyl Estradiol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Examine your breasts monthly as directed by your doctor. Report any lumps right away.
  • Levonorgestrel/Ethinyl Estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Levonorgestrel/Ethinyl Estradiol .
  • Lab tests, including breast exams, Pap tests, physicals, and blood pressure, may be performed while you take 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 yet had their first menstrual period; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not take Levonorgestrel/Ethinyl Estradiol if you are pregnant. 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:

Breast tenderness; changes in appetite; dizziness; headache; mild hair loss; nausea; nervousness; vaginal spotting or breakthrough bleeding; vomiting; weight gain.

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; unusual hoarseness); breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or odor; vision changes (eg, sudden vision loss, double vision); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include severe dizziness, nausea, or vomiting; stomach pain; unusual drowsiness or tiredness; unusual vaginal bleeding.

Proper storage of Levonorgestrel/Ethinyl Estradiol :

Store Levonorgestrel/Ethinyl Estradiol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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.

This information is a summary only. It does not contain all information about Levonorgestrel/Ethinyl Estradiol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition
Copyright © 2007 Wolters Kluwer Health, Inc.

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