The following information is a summary about Seasonale. It is not intended to replace a doctor's instructions.

Seasonale USES
Seasonale (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. Seasonale are a very effective method of birth control, but they do not prevent the spread of AIDS and other sexually transmitted diseases.

Seasonale DIRECTIONS
Seasonale come in packets of 21 or 28 tablets to take by mouth once a day. To avoid upset stomach, take Seasonale with food or milk. Take the tablet routinely at the same time every day (e.g., after dinner or at bedtime) to help you remember to take the tablet regularly. Missing doses increases your risk of becoming pregnant. When first starting on Seasonale, use an additional method of birth control until you have correctly taken 7 days' worth of medicine. If you have a 21-tablet packet, take one tablet daily for 21 days and then none for seven days. Then start a new packet. If you have a 28-tablet packet, take one tablet daily for 28 days. The last seven tablets are a different color. These tablets are not birth-control pills; they contain iron (ferrous fumarate) or an inactive ingredient. You should take one tablet daily continuously for 28 days in the order specified in your packet, starting a new packet the day after taking your 28th tablet. Follow the directions on your prescription label carefully concerning when to take your first tablet (on the first or fifth day of your menstrual period or on the first Sunday after or on which bleeding begins). Take the oral contraceptive exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking Seasonale without talking to your doctor. If you have recently given birth, wait until 4 weeks after giving birth to begin taking Seasonale.

Seasonale SIDE EFFECTS
Seasonale may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: * upset stomach * vomiting * stomach cramps or bloating * diarrhea * constipation * gingivitis (swelling of the gum tissue) * weight gain or weight loss * brown or black skin patches * acne * swelling of the hands, feet, or lower legs (fluid retention) * hair growth in unusual places * bleeding or spotting between menstrual periods * changes in menstrual flow * painful or missed periods * breast tenderness, enlargement, or discharge * difficulty wearing contact lenses Some side effects can be seious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately: * severe headache * shortness of breath * severe vomiting * partial or complete loss of vision * double vision * speech problems * dizziness or faintness * weakness or numbness of an arm or leg * crushing chest pain or chest heaviness * coughing up blood * calf pain * severe stomach pain * yellowing of the skin or eyes * severe depression * unusual bleeding * loss of appetite * extreme tiredness, weakness, or lack of energy * fever * dark-colored urine * light-colored stool * rash Seasonale may increase the risk of developing endometrial and breast cancer, gallbladder disease, liver tumors, heart attack, stroke, and blood clots. Talk to your doctor about the risks of taking this medication. Seasonale may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Seasonale PRECAUTIONS
Before taking Seasonale, * tell your doctor and pharmacist if you are allergic to estrogen, progestin, or any other medications. * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: acetaminophen (APAP, Tylenol); antibiotics; anticoagulants ('blood thinners') such as warfarin (Coumadin); atorvastatin (Lipitor); clofibrate (Atromid-S); cyclosporine (Neoral, Sandimmune); griseofulvin (Fulvicin, Grifulvin, Grisactin); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), and topiramate (Topamax); morphine (Kadian, MS Contin, MSIR, others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone); phenylbutazone; rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); temazepam (Restoril); theophylline (Theobid, Theo-Dur); and thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid). Before taking Yasmin, tell your doctor and pharmacist if you are taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), enalapril (Vasotec), and lisinopril (Prinivil, Zestril); angiotensin II antagonists such as irbesartan (Avapro), losartan (Cozaar), and valsartan (Diovan); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); diuretics ('water pills') such as amiloride (Midamor), spironolactone (Aldactone), and triamterene (Dyrenium); or heparin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. * tell your doctor what herbal products you are taking, especially St. John's wort. * tell your doctor if you have or have ever had breast lumps or cancer; endometrial cancer; high blood pressure; high blood cholesterol and fats; diabetes (high blood sugar); asthma; stroke; blood clots; toxemia (high blood pressure during pregnancy); heart attack; epilepsy (seizures); migraine headaches; depression; liver, heart, gallbladder, or kidney disease; adrenal insufficiency (for Yasmin); jaundice (yellowing of the skin or eyes); vaginal bleeding between menstrual periods; and excessive weight gain and fluid retention (bloating) during the menstrual cycle. * do not take Seasonale if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Seasonale, call your doctor immediately. * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Seasonale. * tell your doctor and pharmacist if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while taking hormone replacement therapy, see an eye doctor.

Seasonale OVERDOSE
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Seasonale NOTES
Keep all appointments with your doctor and the laboratory. You should have a complete physical examination every year, including blood pressure measurements, breast and pelvic exams, and a Pap test. Follow your doctor's directions for examining your breasts; report any lumps immediately. Before you have any laboratory tests, tell the laboratory personnel that you take Seasonale, as Seasonale may interfere with some laboratory tests. If you miss one menstrual period and have taken your tablets as directed, continue taking them. However, if you miss one period and have not taken your tablets as directed or if you miss two menstrual periods and have taken the tablets as directed, call your doctor and use another method of birth control until you have a pregnancy test. If you wish to stop taking Seasonale and become pregnant, use another method of birth control for at least 3 months after you stop taking the tablets to be sure that the medication will not harm the fetus. It may take a long time for you to become pregnant after you stop taking Seasonale, especially if you have never had a baby or if you had irregular, infrequent, or complete absence of menstrual periods before taking Seasonale. Questions should be discussed with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

MISSED DOSE
If you miss doses of your oral contraceptive, you may be at risk for becoming pregnant. Instructions about missed doses are different for different products. Carefully read the instructions in the manufacturer's information for the patient. If you have any questions, call your doctor or pharmacist. If you miss pills, you may need to use a backup method of birth control for 7 days or until the end of the cycle.

Seasonale STORAGE
Keep Seasonale in the packet it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.