When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to drospirenone, ethinyl estradiol, or levomefolate, or if you are pregnant. Do not use this medicine if you have certain heart problems, adrenal gland problems, kidney disease, liver disease, migraines, unusual vaginal bleeding that has not been checked by a doctor, or kidney, eye, nerve, or blood vessel damage caused by diabetes. Do not use this medicine if you have a history of breast cancer, blood clots, heart attack, or stroke.

How to Use This Medicine:
Tablet, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. It is best to take this medicine at the same time every day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Use a second form of birth control for the first 7 days of your first cycle of pills. Your body will need at least 7 days to adjust to the new medicine before a pregnancy will be prevented.
• If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, follow the patient instructions or call your doctor.
• Missed dose: If you miss a dose, read and follow the patient instructions carefully. Call your doctor if you have any questions.
• To prevent pregnancy, use a second form of birth control for 7 days after you miss a dose.
• If you miss a pill or change your schedule, you may not have a period that month. Tell your doctor if you miss your period 2 months in a row, because you may be pregnant.
• You could have light bleeding or spotting if you do not take your pills on a regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  
  • St John's wort, acetaminophen, ascorbic acid (vitamin C), atorvastatin, bosentan, cholestyramine, felbamate, griseofulvin, heparin, itraconazole, ketoconazole, methotrexate, pyrimethamine, rifampicin, or sulfasalazine
  • Medicine to lower blood pressure, a diuretic (water pill), an NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen), medicine for seizures (such as carbamazepine, oxcarbazepine, lamotrigine, phenobarbital, phenytoin, primidone, topiramate, valproic acid), medicine for HIV/AIDS, thyroid medicine, or folate or potassium supplements

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you had a baby within the last 4 weeks. Tell your doctor if you have hereditary angioedema, diabetes, high blood pressure, high cholesterol, or a history of depression or chloasma gravidarum. Tell your doctor if you had liver problems caused by pregnancy or birth control pills. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Liver problems
  • Possible increased risk of breast or cervical cancer
  • High blood pressure
  • Gallbladder disease
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases. Talk to your doctor if you have concerns about this.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for a long time. This medicine may affect the results of certain medical tests.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Confusion, weakness, uneven heartbeat, or numbness in your hands, feet, or lips
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Heavy vaginal bleeding, irregular or missed menstrual period
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Severe stomach pain, nausea, vomiting, fever
• Vision blurring or loss

If you notice these less serious side effects, talk with your doctor:

• Breast pain, tenderness, or swelling
• Depression or mood changes
• Mild headache or stomach upset
• Vaginal spotting or light bleeding, itching, or discharge

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088