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 or ethinyl estradiol, or if you are pregnant. Do not use it if you have unusual vaginal bleeding that has not been checked by your doctor, kidney disease, liver disease, adrenal problems, certain heart problems, a blood clotting disorder, or diabetes with kidney, eye, nerve, or blood vessel damage. Do not use it if you have a history of breast cancer.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Each brand of birth control pills has specific directions. Follow the patient instructions for your prescribed brand. Talk to your doctor or pharmacist if you have any questions.
• Take this medicine at the same time each day, preferably after your evening meal or at bedtime. Birth control pills work best when there is no more than 24 hours between doses. Keep the pills in the original container. Take the pills in the order they appear in the container.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.
• Missed dose: Carefully follow the patient instructions if you miss a dose. You may need to use a second form of birth control for several days. Ask your doctor or pharmacist if you have any questions.
• 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.

• There are many foods and medicines can affect how drospirenone/ethinyl estradiol works. Tell your doctor about all medicines that you are using.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor right away if you become pregnant. This medicine could harm your unborn baby if you take it while you are pregnant.
• Tell your doctor if you are breastfeeding, or if you had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have inherited angioedema, diabetes, heart or blood vessel disease, high blood pressure, high cholesterol, migraines, or a history of depression or chloasma, especially during pregnancy. Tell your doctor if you have ever had cholestasis (jaundice) caused by pregnancy or birth control pills. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  
  • Increased risk of blood clots, which may cause a stroke or heart attack
  • Possible increased risk of breast or cervical cancer
  • Liver problems
  • High blood pressure
  • Gallbladder disease
• You may need to stop using this medicine for a few weeks before and after you have surgery because of the risk of blood clots.
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases. Talk with your doctor if you have questions.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check the effects of this medicine at regular visits. He may also monitor your blood pressure. 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, numbness in your hands, feet, or lips
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Irregular, late, or missed menstrual period
• Numbness or weakness on one side of your body, pain in your lower leg, sudden or severe headache, problems with vision, speech, or walking
• Severe stomach pain, nausea, vomiting
• Unusual or unexpected vaginal bleeding or heavy bleeding

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

• Breast pain or tenderness
• Headache
• Mild nausea, bloating
• Vaginal spotting, light bleeding, itching, 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