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Generic Name: levonorgestrel/ethinyl estradiol (lee-voe-nor-JES-trel/ETH-i-nil es-tra-DYE-ol)
Brand Name: Lybrel
Smoking cigarettes while using Lybrel increases your chance of having serious heart problems. Do not smoke while using Lybrel. 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.
Lybrel is used for:
Preventing pregnancy. It may be used for other conditions as determined by your doctor.
Lybrel 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 Lybrel if:
- you are allergic to any ingredient in Lybrel
- 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 Lybrel:
Some medical conditions may interact with Lybrel. 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 Lybrel. 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 Lybrel's effectiveness or increase the risk of Lybrel'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 Lybrel'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 Lybrel
- Lamotrigine because its effectiveness may be decreased by Lybrel
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lybrel 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 Lybrel:
Use Lybrel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Lybrel. Talk to your pharmacist if you have questions about this information.
- Take Lybrel 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 Lybrel.
- Begin taking Lybrel 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 Lybrel, be sure you know when you should start taking Lybrel. Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to Lybrel.
- Try to take Lybrel 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 Lybrel 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 Lybrel, follow the directions for what to do if you miss a pill.
- If you miss 1 dose of Lybrel, 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 Lybrel, read the extra patient information leaflet that comes with Lybrel or contact your doctor for instructions. If you miss one or more doses of Lybrel, 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 Lybrel.
Important safety information:
- Lybrel may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Lybrel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Lybrel 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 Lybrel.
- You could become pregnant if you miss 1 or more doses of Lybrel. 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 Lybrel.
- 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 Lybrel. Do not stop taking Lybrel if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
- The effectiveness of Lybrel 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 Lybrel before you receive any medical or dental care, emergency care, or surgery. If possible, Lybrel 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 Lybrel 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.
- Lybrel may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to Lybrel. 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 Lybrel. This effect may be greater in patients who had irregular periods before starting Lybrel. Discuss any concerns with your doctor or pharmacist.
- Lybrel 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 - Lybrel 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.
- Lybrel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Lybrel.
- Lab tests, including breast exams, Pap tests, physicals, and blood pressure, may be performed while you take Lybrel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Lybrel 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 Lybrel if you are pregnant. If you think you may be pregnant, contact your doctor right away. Lybrel is found in breast milk. Do not breast-feed while taking Lybrel.
Possible side effects of Lybrel:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast tenderness; changes in appetite; dizziness; headache; mild hair loss; nausea; nervousness; vaginal spotting or breakthrough bleeding; vomiting; weight gain.
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 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. Symptoms may include severe dizziness, nausea, or vomiting; stomach pain; unusual drowsiness or tiredness; unusual vaginal bleeding.Proper storage of Lybrel:
Store Lybrel 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 Lybrel out of the reach of children and away from pets.
- If you have any questions about Lybrel, please talk with your doctor, pharmacist, or other health care provider.
- Lybrel 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 Lybrel 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 Lybrel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lybrel. 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 Lybrel.