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Estradiol/dienogest (By mouth)

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

Prevents pregnancy. Also treats heavy menstruation. This medicine is an oral contraceptive (birth control pill).

Brand Name(s):

Natazia

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to estradiol valerate and dienogest or if you are pregnant or have unusual vaginal bleeding that has not been checked by a doctor. You should not use this medicine if you have uncontrolled high blood pressure, certain heart problems, or diabetes with kidney, eye, or blood vessel damage. Do not use this medicine if you have breast cancer, cancer of the uterus or cervix, liver disease, or certain types of headaches. You should not use this medicine if you have a history of blood clots, heart attack, or stroke. Do not use this medicine if you smoke cigarettes and you are older than age 35.

How to Use This Medicine:

Tablet

  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Take this medicine at the same time every day. Birth control pills work best when there is no more than 24 hours between doses.
  • Keep your pills in the blister pack you receive from the pharmacy. Take the pills in the order they appear in the container.
  • If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, follow the instructions in the leaflet given by your doctor or call your doctor.

If a dose is missed:

  • This medicine has specific instructions on what to do if you miss a dose. Read and follow these instructions carefully. You may need to use a second form of birth control for several days. Call your doctor if you have any questions.
  • If you miss your pills and change your schedule, you may not have a period for that month. Make sure your doctor knows if you miss your period 2 months in a row, because you may be pregnant.
  • You could have light bleeding or spotting any time you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you also use medicine to treat infections (such as clarithromycin, erythromycin, griseofulvin, itraconazole, ketoconazole, rifampicin, Ery-Tab®, Grisactin®, Grisovin®, Ketek®, Nizoral®, Rifadin®, Rimactane®, or Sporanox®), medicine for seizures (such as carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, topiramate, Dilantin®, Felbatol®, Lamictal®, Tegretol®, Topamax®, or Trileptal®), medicine to treat depression (such as nefazodone, Serzone®), medicine used to treat HIV or AIDS (such as ritonavir, saquinavir, or Norvir®), thyroid replacement hormones (such as levothyroxine, Synthroid®), bosentan (Tracleer®), cimetidine (Tagamet®), diltiazem (Cardizem®), verapamil (Calan®, Isoptin®, Verelan®), or St John's wort.
  • 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 have become pregnant while using the medicine. Although the risk is low, this medicine could harm your unborn baby.
  • Make sure your doctor knows if you are breastfeeding or if you have had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have kidney disease, gallbladder disease, inherited angioedema (swelling of the face, tongue, or throat), diabetes, high blood pressure, high cholesterol, or a history of chloasma or depression. Also tell your doctor if you have ever had jaundice (yellow eyes or skin) caused by pregnancy or birth control.
  • If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are older than age 35, are overweight, or have diabetes, high blood pressure, high cholesterol. Talk with your doctor about ways to stop smoking.
  • Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or lower legs, trouble breathing, severe or sudden headache, slurred speech, sudden loss of coordination, or vision changes while using this medicine.
  • Check with your doctor immediately if you have trouble wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your eyes may need to be checked by an eye doctor.
  • Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. Talk with 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 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.

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
  • Changes in vision
  • Chest pain, trouble breathing, or coughing up blood
  • Dark-colored urine or pale stools
  • Heavy vaginal bleeding
  • Irregular or missed menstrual period
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach
  • Numbness or weakness in your arm or leg, or on one side of your body
  • Pain in your lower leg (calf)
  • Sudden or severe headache, or problems with vision, speech, or walking
  • Yellow skin or eyes

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

  • Breast pain, tenderness, or swelling
  • Depression or mood changes
  • Headache
  • Mild nausea
  • 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


Last Updated: 8/4/2014


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