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 estradiol. Do not use it if you may be pregnant, or if you have adrenal gland disease, kidney disease, liver disease, or unusual vaginal bleeding that has not been checked by a doctor. Do not use this medicine if you have a history of breast or uterine cancer, heart attack, stroke, or blood clots.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole with liquids. Do not break, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. You may have vaginal bleeding if you forget to take your medicine for several days.
• 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 foods and medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  
  • St John's wort, carbamazepine, clarithromycin, erythromycin, heparin, itraconazole, ketoconazole, phenobarbital, rifampin, ritonavir
  • Medicine to lower blood pressure, an NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen), a diuretic (water pill), or a potassium supplement
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby.
• Tell your doctor if you have endometriosis, asthma, diabetes, epilepsy, hereditary angioedema, lupus, migraines, porphyria, a thyroid problem, heart disease, high blood pressure, or high cholesterol. Tell your doctor if you had liver problems caused by pregnancy or estrogen.
• Do not breastfeed while you are using this medicine, unless your doctor says it is okay.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Higher risk of endometrial, breast, or uterine cancer
  • Higher risk of dementia
  • Gallbladder disease
  • High blood pressure
• 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
• Breast lump
• Chest pain, trouble breathing, coughing up blood
• Confusion, weakness, uneven heartbeat, numbness in your hands, feet, or lips
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting, fever
• Unusual vaginal bleeding or discharge
• Vision blurring or loss

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

• Breast pain, swelling, or tenderness
• Headache
• Mild stomach pain

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