Dienogest and estradiol is a combination drug that contains female hormones that prevent ovulation (the release of an egg from an ovary). dienogest and estradiol also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Dienogest and estradiol is used to prevent pregnancy. This medicine is also used to treat heavy menstrual bleeding that is not caused by any medical condition of the uterus.

Dienogest and estradiol may also be used for purposes not listed in this medication guide.

Do not use dienogest and estradiol if you are pregnant or if you have recently had a baby.

You should not take this medicine if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take dienogest and estradiol if you smoke and are over 35 years old.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your medicine.

dienogest and estradiol contains 5 different colors of pills. Take 1 pill each day in the exact order directed on the blister pack. Follow the arrows shown on each row of pills in the pack. Use a back-up birth control, such as condoms or a spermicide, for the first 9 days. Do not take two different kinds of birth control pills at the same time.

If you are switching from another birth control pill, start taking dienogest and estradiol on the first day of your period. If you were taking progestin-only pills, start taking dienogest and estradiol on the day you would have taken your next pill.

If you are switching from a birth control implant, intrauterine device (IUD), vaginal ring, or skin patch, start taking dienogest and estradiol on the day the other birth control device is removed. If you are switching from a birth control injection, start taking dienogest and estradiol on the day you would have received your next scheduled injection.

Tell your doctor if you have heavy breakthrough bleeding. You may also have very little or no bleeding during your periods.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using dienogest and estradiol.

While taking dienogest and estradiol, you will need to visit your doctor regularly.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Contraception:

1 tablet orally at the same time every day
-Tablets must be taken in the order directed on the blister pack.

Comments:
-Efficacy in women with a body mass index over 30 kg/m2 has not been evaluated.
-To start: Take the first pill on the first day of the menstrual cycle; non-hormonal back-up contraceptives should be used for the first 9 days.
-Starting postpartum: Start no earlier than 4 weeks postpartum due to increased thromboembolism risk; if no period has occurred, rule out pregnancy; non-hormonal back-up contraceptives should be used for the first 9 days.
-Switching from another combination hormonal method: Take the first pill on the first day of withdrawal bleeding; if no withdrawal bleeding occurred, rule out pregnancy.
-Switching from vaginal ring or transdermal patch: Take the first pill on the day the ring/patch is removed; non-hormonal back-up contraceptives should be used for the first 9 days.
-Switching from a progestin-only method: Take the first pill on the day the next progestin-only pill would have been taken, the day of removal of an implant, or the day the next injection would have occurred; non-hormonal back-up contraceptives should be used for the first 9 days.

Uses:
-Pregnancy prevention
-Treatment of heavy menstrual bleeding without organic pathology in women who choose oral contraceptives for contraception

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking dienogest and estradiol. Your risk is also high when you restart this medicine after not taking it for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take this medicine if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop taking this medicine and tell your doctor if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking this medicine.

You should not take dienogest and estradiol if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);

• a blood-clotting disorder or circulation problems;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease or liver cancer;

• severe migraine headaches; or

• if you smoke and are over 35 years old.

To make sure this medicine is safe for you, tell your doctor if you have:

• high blood pressure, high cholesterol or triglycerides, or if you are overweight;

• a history of depression;

• diabetes, underactive thyroid, gallbladder disease;

• seizures or epilepsy; or

• a history of jaundice caused by pregnancy or birth control pills.

The hormones in dienogest and estradiol can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding a baby.

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill by more than 12 hours increases your risk of becoming pregnant. Vomiting or having diarrhea within 4 hours after taking a pill is the same as missing that dose.

If you miss one pill:

• During Days 1 through 17, take the missed pill as soon as you remember, then take your next pill at the usual time. Use back-up birth control for at least 9 days.

• During Days 18 through 24, throw out the rest of the pack and start a new one the same day. Take the Day 1 pill from the new pack and then take one pill per day in the order directed on the pack. Use back-up birth control for at least 9 days.

• During Days 25 through 28, take the missed pill as soon as you remember, then take your next pill at the usual time. You do not need back-up birth control if you miss one pill during Days 25 through 28.

If you miss two pills:

• During Days 1 through 16, skip the missed pills and start with the pill that corresponds to the day you remember you missed your doses. Then take one pill per day in the order directed on the pack. Use your back up birth control for at least 9 days

• During Days 17 through 24, throw out the rest of the pack and start a new one the same day. Take the Day 3 pill from the new pack and then take one pill per day in the order directed on the pack. Use your back up birth control for at least 9 days.

• During Days 25 through 28, throw out the rest of the pack. Start a new pack on the same day or on the day you would normally start a new pack. Take one pill per day in the order directed on the pack. No back up birth control is needed.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Do not smoke while taking dienogest and estradiol, especially if you are older than 35 years of age.

Dienogest and estradiol will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot--chest pain, sudden cough, wheezing, coughing up blood, swelling or warmth in one or both legs;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems--severe stomach pain, fever, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• sudden and severe pelvic pain;

• a change in the pattern or severity of migraine headaches;

• swelling in your hands, ankles, or feet;

• a breast lump; or

• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects of dienogest and estradiol may include:

• light vaginal bleeding or spotting;

• nausea (especially during the first few months of taking this medicine), vomiting;

• breast pain or tenderness;

• weight gain; or

• problems with contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with birth control pills and make them less effective, which may result in pregnancy. Estradiol can also affect blood levels of certain other drugs, making them less effective or increasing side effects. You may need to use a back-up birth control method while using certain other drugs. Tell your doctor about all your current medicines and any you start or stop using. Not all possible interactions are listed in this medication guide.