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 estradiol valerate or dienogest, or if you are pregnant. Do not use it if you have breast cancer, heart disease, liver disease, or history of blood clots (such as deep vein thrombosis, pulmonary embolism, or stroke).

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Each brand of birth control pills has specific directions. Read and follow the instructions for your prescribed brand. Ask your doctor or pharmacist if you have any questions.
• Take this medicine at the same time each day. Birth control pills work best when there is no more than 24 hours between doses.
• Use a second form of non-hormone birth control for the first 9 days of your first cycle of pills. Your body will need at least 9 days to adjust to this medicine before pregnancy will be prevented.
• Missed dose: This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully. Call your doctor if you have any questions.
  
  • If you vomit or have diarrhea within 4 hours after taking this medicine, count it as a missed dose.
  • You may not have a period for that month if you miss more than one dose or change your schedule.
  • You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
• 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 estradiol and dienogest work. Tell your doctor if you are using any of the following:
  
  • Bosentan, carbamazepine, diltiazem, felbamate, griseofulvin, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rifampin, St John's wort, topiramate, verapamil
  • Medicine to treat an infection (including clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, voriconazole)
  • Medicine to treat HIV or hepatitis C infection
  • Thyroid medicine
• 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 think you are pregnant or if you miss your period 2 months in a row, because you could be pregnant.
• Tell your doctor if you have cancer, diabetes, blood circulation problems, or migraine headaches, or if you smoke. Tell your doctor if you are breastfeeding, or if you have recently given birth. Also tell your doctor if you have kidney disease, high blood pressure, gallbladder disease, high cholesterol, or a history of depression, angioedema, or jaundice.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Possible risk of breast or cervical cancer
  • Liver cancers or tumors
  • High blood pressure
  • Gallbladder disease
• This medicine may make your periods lighter or shorter, and you might not have a period in some cycles. However, tell your doctor if you miss 2 periods in a row, or if you miss 1 period and did not take the pills on schedule during the month. You might be pregnant.
• 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.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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, or coughing up blood
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Double vision or other trouble seeing
• New or unusual headaches
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your lower leg (calf)
• Unusual or unexpected vaginal bleeding or heavy bleeding

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

• Breast tenderness
• Headache
• Mild nausea
• Light spotting or bleeding between periods
• Skin color changes or dark patches

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