LoSeasonique extended-cycle

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Some drugs can make birth control pills less effective, which may result in pregnancy. Other drugs may interact with ethinyl estradiol and levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Taking LoSeasonique can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking LoSeasonique. Your risk is also high when you restart this medicine after not taking it for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take this medicine if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking LoSeasonique.

You should not take LoSeasonique if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);

• a blood-clotting disorder or circulation problems;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease or liver cancer;

• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

• a history of jaundice caused by pregnancy or birth control pills; or

• if you smoke and are over 35 years old.

To make sure LoSeasonique are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;

• high cholesterol or triglycerides, or if you are overweight;

• a history of depression;

• diabetes, underactive thyroid, gallbladder disease;

• seizures or epilepsy;

• a history of irregular menstrual cycles;

• tuberculosis; or

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in LoSeasonique can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

Do not smoke while taking LoSeasonique, especially if you are older than 35 years of age.

LoSeasonique will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Get emergency medical help if you have signs of an allergic reaction to LoSeasonique: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using LoSeasonique and call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

• a change in the pattern or severity of migraine headaches;

• nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet;

• a breast lump; or

• symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Common LoSeasonique side effects may include:

• mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;

• breast tenderness or swelling, nipple discharge;

• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;

• changes in weight or appetite;

• problems with contact lenses;

• vaginal itching or discharge; or

• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Common side effects of LoSeasonique include: vulvovaginal candidiasis, breakthrough bleeding, decreased glucose tolerance, headache, increased blood pressure, migraine, spotty menstruation, vaginitis, dizziness, and breast tension. Other side effects include: uterine hemorrhage, abdominal cramps, abdominal distention, acne vulgaris, breast changes, dysmenorrhea, nausea, and vomiting. See below for a comprehensive list of adverse effects.