IMPORTANT NOTE The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

TITLE LEVONORGESTREL/ETHINYL ESTRADIOL EXTENDED CYCLE ORAL CONTRACEPTIVE

HOW TO PRONOUNCE (LEE-voe-nor-jes-trel/ETH-in-il es-tra-DYE-ole)

COMMON BRAND NAMES Seasonale

WARNINGS Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke. The risk of heart problems increases with age (especially in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).

USES This medication is used to prevent pregnancy. This medication is a combination of two types of hormones (levonorgestrel, a progestin and ethinyl estradiol, an estrogen). Besides preventing pregnancy, similar birth control pills have been shown to decrease anemia, painful periods (dysmenorrhea), ovarian cysts, the number of episodes of pelvic inflammatory disease, and decrease the occurrence of certain cancers (uterine, ovarian). Using this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

HOW TO TAKE Begin taking this medication on the first Sunday following the beginning of your period (menstruation). If your period begins on a Sunday, begin taking this medication on that day. Take one "active" pill (pills that contain the hormones) once daily for 84 days in a row. Following these active pills, you will then take an "inactive" pill (pills that do not contain the hormones) once daily for 7 days in a row. After the last inactive pill, you will repeat the same cycle the very next day, starting again with an active pill. For this medication to be effective you must try to take this medication at the same time each day, not more than 24 hours apart. Pick a time that will be easy for you to remember. Use an additional form of birth control (e.g., condom or spermicide) during the first week of taking this medication since it will take a while to be effective. A Patient Information Leaflet about this drug should be dispensed with each prescription. Read the information carefully. Ask your doctor or pharmacist any questions you may have regarding this medication.

SIDE EFFECTS Dizziness, headache, stomach upset, bloating, nausea, vomiting, trouble sleeping, vaginal discomfort/irritation, increased vaginal discharge, or vaginal bleeding between periods may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: dark patches on the skin or face (melasma), weight changes (gain or loss), problem wearing contact lenses, depression, mental/mood changes. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, coughing up blood, shortness of breath, groin or calf pain/swelling, one-sided weakness, vision problems/changes, slurred speech, confusion, sudden severe headache, lumps in the breast, severe stomach/abdominal pain, tingling/weakness/numbness in the arms/leg, yellowing of eyes or skin, dark urine. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, severe swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots (e.g., in the legs, groin, lungs), history of heart disease or stroke, heart valve disease, severe high blood pressure, diabetes (especially affecting the circulation), severe headaches, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, cancer (especially endometrial or breast cancer), undiagnosed abnormal vaginal bleeding, liver problems, currently pregnant, heavy tobacco use (if 35 years old or greater). Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, high blood level of cholesterol or triglycerides (fats), gallbladder problems, kidney problems, thyroid problems, migraine headaches, depression, recent pregnancy, smoking, obesity, any allergies (especially to hormones used in other birth control pills). You should have your period (withdrawal bleeding) when you are taking the inactive pills. If bleeding does not occur, contact your doctor immediately. Your doctor will need to check to see if you are pregnant. Bleeding or spotting between your periods may occur while taking this medication. If this bleeding continues for more than 7 days or is heavy, contact your doctor. This drug may cause a patchy, darkening of the skin on the face (melasma). Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. There may be a delay in becoming pregnant after you stop taking birth control pills. Consult your doctor. Birth-control pills slightly increase your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors. Cigarette smoking (especially 15 or more cigarettes daily) and age (women older than 35/smokers or 40/nonsmokers years of age) further increase the risk of stroke, blood clots, high blood pressure and heart attacks. Ask your pharmacist or doctor for a copy of the patient labeling which explains these risks in more detail. Consult your doctor for any questions, including possible use in nonsmokers over 40 years of age. If you are near-sighted or wear contact lenses, you may develop vision problems. Also, your tolerance of the lenses may decrease. Contact your eye doctor if these problems occur. If you will be having surgery, be confined to a chair or bed for a long period of time (e.g., a long plane flight), or have recently delivered a baby, notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk. This may affect milk production and may have harmful effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS This drug should not be used with the following medications because very serious interactions may occur: troleandomycin. If you are currently using any of these medications, tell your doctor or pharmacist before starting this birth control pill. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: cyclosporine, corticosteroids (e.g., prednisolone), theophylline, beta-blockers (e.g., metoprolol), thyroid hormones, temazepam, aspirin, morphine, clofibric acid, acetaminophen, ascorbic acid (vitamin C), atorvastatin, azole antifungals (e.g., itraconazole, ketoconazole). Certain drugs can decrease the effectiveness of combination-type birth control pills by decreasing the amount of birth control hormones in your system (impaired enterohepatic recirculation or hepatic induction). This can result in pregnancy. Consult your doctor or pharmacist for details. Drugs that may cause this effect include: griseofulvin, many antibiotics (e.g., penicillins, macrolides, tetracyclines, sulfas, cephalosporins, chloramphenicol), many seizure medications (e.g., phenytoin, barbiturates, primidone, carbamazepine, topiramate), dapsone, rifamycins (e.g., rifampin), modafinil, St. John's wort, nevirapine, bosentan, aprepitant, certain HIV protease inhibitors (e.g., amprenavir, nelfinavir, ritonavir). Ask your doctor if you should use additional reliable birth control methods while taking any of the drugs mentioned above while also taking birth control pills. This product can affect the results of certain lab tests (e.g., thyroid). Inform all laboratory personnel that you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe nausea, vomiting, and unusual vaginal bleeding or irregular menstrual periods.

NOTES Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.

MISSED DOSE If you miss a dose, use it as soon as you remember. Take the next dose at your regular time. This may mean taking 2 doses on the same day. If you miss 2 active pills in a row, take 2 pills on the day you remember and 2 pills the next day. Then return to 1 pill per day dosing. You must use another form of birth control (e.g., condoms or spermicides) as a back-up for 7 days after you restart your pills. If you miss 3 or more active pills in a row, leave the missed pills in the pack. Keep taking 1 pill every day as indicated on the pack until you complete the pack. You must use another form of birth control as a back-up for 7 days after you restart your pills. If you miss any of the 7 inactive pills, throw away the missed inactive pill and finish the rest of the pills in the pack on schedule. You do not need to use back-up birth control if you miss taking an inactive pill. If you have any questions about what to do if you miss a pill, consult your doctor, pharmacist, or the Patient Information Leaflet available from your pharmacist.

STORAGE Store at room temperature between 68 and 77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.