Dienogest (dye-EN-oh-jest), Estradiol Valerate (es-tra-DYE-ol VAL-er-ate)

Prevents pregnancy. Also treats heavy monthly periods.

Brand Name(s):

Natazia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use a second form of birth control for the first 9 days of your first cycle of pills. Your body will need at least 9 days to adjust to the new medicine before a pregnancy will be prevented.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Carefully follow your doctor's instructions about when to start taking your medicine. You will begin taking the pills on the first day of your menstrual period.
• 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.
• 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 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the patient instructions or call your doctor.
  • 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 this medicine works. 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/AIDS 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:

• Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding, or if you have given birth within 4 weeks before you start using this medicine. Tell your doctor if you have kidney disease, diabetes, gallbladder disease, hereditary angioedema, high blood pressure, high cholesterol, migraines, or a history of cervical cancer, depression, weight changes, or chloasma gravidarum (skin disorder during pregnancy). Tell your doctor if you smoke or if you are having surgery that requires inactivity for a long time. Tell your doctor if you wear contact lenses.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of breast or cervical cancer
  • Liver cancers or tumors
  • High blood pressure
  • Gallbladder disease
  • High cholesterol in the blood
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections.
• This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• You might have some light bleeding or spotting.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• 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 do lab tests at regular visits to check on the effects of this medicine. 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 lumps, tenderness, pain, swelling, or discharge
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Sudden or severe headache, or problems with vision, speech, or walking
• Unusual moods or behavior, depression
• Unusual, unexpected, or heavy vaginal bleeding
• Vision loss, double or blurred vision

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

• Increased weight
• 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