DrugindexOnline^{2nd edition}

Generic Name: Levonorgestrel/Ethinyl Estradiol Tablets 28-Day Pack (LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol)
Brand Name: Examples include Alesse and Levlen

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

Alesse is used for:

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

Alesse is a combination birth control pill. It works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus.

Do NOT use Alesse if:

• you are allergic to any ingredient in Alesse
• you have a history of blood clotting problems; heart disease; irregular heartbeat due to clotting problems; blood vessel problems (eg, blood flow problems in the brain or heart, stroke); chest pain (eg, heart attack, angina); certain types of headaches or migraines; uncontrolled high blood pressure; diabetes that affects circulation; breast cancer; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; undiagnosed vaginal bleeding; yellowing of the eyes or skin due to pregnancy or prior birth control use; or liver disease or tumors
• you are or suspect that you are pregnant
• you have had surgery and are confined to a bed or a 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 Alesse :

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

• if you are 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 pressure, high blood cholesterol or lipid levels, 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

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

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alesse 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 Alesse :

Use Alesse as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Alesse . Talk to your pharmacist if you have questions about this information.
• Take Alesse by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Begin taking Alesse 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 Alesse on that day. Try to take Alesse 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 Alesse to be effective it must be taken every day. Do not skip doses.
• If you miss a dose of Alesse 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 Alesse , see the additional patient information leaflet that comes with Alesse 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 Alesse , 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 Alesse .

Important safety information:

• Alesse may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Alesse 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 Alesse .
• Alesse may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protected clothing when exposed to the sun, sunlamps, or tanning booths.
• Use of Alesse will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).
• Bleeding or spotting may occur while taking Alesse . Do not stop taking Alesse if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
• Smoking while using Alesse may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.
• Alesse may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Alesse .
• Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using Alesse may decrease the effectiveness of Alesse . To prevent pregnancy, use an additional form of birth control until your next period.
• If you wear contact lens 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.
• Alesse may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping this medicine.Discuss any concerns with your doctor or pharmacist.
• Lab tests, such as PAP tests, may be performed while you use Alesse . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Alesse 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 Alesse if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Alesse is found in breast milk. Do not breast-feed while taking Alesse .

Possible side effects of Alesse :

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/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; sudden partial or complete loss of vision; sudden severe headache or vomiting; shortness of breath; 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 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 nausea; vaginal bleeding; vomiting.

Proper storage of Alesse :

Store Alesse 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 Alesse out of the reach of children and away from pets.

General information:

• If you have any questions about Alesse , please talk with your doctor, pharmacist, or other health care provider.
• Alesse 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 Alesse . 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.