Estradiol/dienogest (By mouth)

Brand Name(s)

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should 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. 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 or if you are over age 35. Do not use this medicine if you have ever had jaundice (yellow eyes or skin) caused by pregnancy or birth control.

How to Use This Medicine

Tablet, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Carefully follow your doctor's instructions about when to start taking your medicine. You may begin taking the pills on the first day of your menstrual period. Use a second form of birth control during the first nine days. Some other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
• Take this medicine at the same time every day. Birth control pills work best when there is no more than 24 hours between doses. It is very important that you take this medicine on time every day.
• Keep your pills in the blister pack you receive from the pharmacy. Take the pills in the order they appear in the container.
• You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.
• 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 patient instructions on what to do if you miss a dose. Read and follow these instructions carefully, and 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 two 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.
• To prevent pregnancy, you should use a second form of birth control for the next nine days after you miss a dose.

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 away from children and 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 are also using medicine to treat infections (such as erythromycin, griseofulvin, ketoconazole, itraconazole, rifampicin, Ery-Tab®, Grisactin®, Grisovin®, Nizoral®, Rifadin®, Rimactane®, or Sproranox®), 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®), 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

• 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. If you think you have become pregnant while using the medicine, tell your doctor right away.
• 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 fats in the blood, or a history of depression.
• 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 over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
• Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; severe, sudden headache; slurred speech; sudden, unexplained shortness of breath; sudden loss of coordination; or vision changes while using this medicine.
• Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; 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 may not work as well in women with a body mass index (BMI) of more than 66 pounds per square meter.
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

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 pain, tenderness, or swelling.
• Chest pain, shortness of breath, 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.
• Yellowing of your skin or the whites of your eyes.

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

• Acne, or darkened skin on your face.
• Bloated or full feeling.
• Change in vision.
• Depression or mood changes.
• Mild nausea, vomiting, or stomach pain.
• Sensitivity to sunlight.
• Vaginal spotting or light bleeding, itching, or discharge.
• Weight gain.

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

Introduction

Prevents pregnancy. This medicine is an oral contraceptive (birth control pill).