Do not use this medicine 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 is a combination drug that contains female hormones that prevent ovulation (the release of an egg from an ovary). This medicine 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.
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:
To make sure this medicine is safe for you, tell your doctor if you have:
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.
This medicine 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.
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:
If you miss two pills:
If you miss a period for two months in a row, call your doctor because you might be pregnant.
Do not smoke while taking this medicine, 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:
Common side effects may include:
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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