dienogest and estradiol

What is the most important information I should know about dienogest and estradiol?

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

This medication can harm an unborn baby or cause birth defects. Do not use dienogest and estradiol if you are pregnant.

Do not use this medication if you have a history of heart attack or stroke, a history of blood clot or coronary artery disease, circulation problems (especially if caused by diabetes), a blood clotting disorder, breast or uterine cancer, abnormal vaginal bleeding, eye problems or kidney problems caused by diabetes, liver disease or liver cancer, uncontrolled high blood pressure, severe migraine headaches, a heart valve or heart rhythm disorder, or if you smoke and you are over 35 years old.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use.

What is dienogest and estradiol?

Dienogest and estradiol is a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication 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 as contraception to prevent pregnancy.

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

What should I discuss with my healthcare provider before using dienogest and estradiol?

This medication can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Tell your doctor right away 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 birth control pills.

Do not use this medication if you are allergic to dienogest or estradiol, or if you have:

• a history of heart attack, stroke, blood clot, or coronary artery disease;
• a blood-clotting disorder, untreated or uncontrolled high blood pressure;
• a hormone related cancer such as breast or uterine cancer;
• abnormal vaginal bleeding;
• problems with your eyes, kidneys, or circulation caused by diabetes;
• liver disease or liver cancer;
• severe migraine headaches;
• a heart valve or heart rhythm disorder; or
• if you smoke and you are over 35 years old.

To make sure you can safely take this medicine, tell your doctor if you have any of these other conditions:

• a history of depression;
• high blood pressure, heart disease, congestive heart failure, high cholesterol or triglycerides;
• diabetes;
• underactive thyroid; or
• a history of jaundice caused by birth control pills.

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

How should I take dienogest and estradiol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Take your first pill on the first day of your period or on the first Sunday after your period begins. Follow the directions on your prescription label. The 28 day birth control pack contains five different colors of pills. Take one pill each day in the exact order directed on the blister pack.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.

You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions. Do not take two different kinds of birth control pills at the same time.

If you are switching to this medication from another birth control pill, start taking dienogest and estradiol on the first day of your withdrawal bleeding and stop taking the other birth control pills. If you were taking progestin only pills before, 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.

You may have breakthrough bleeding. Tell your doctor if this bleeding continues or is very heavy.

Use a back up birth control if you are sick with severe vomiting or diarrhea. Vomiting within 4 hours after your dose is the same as missing a pill.

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 12 hours late in taking your pill, take the missed dose as soon as you remember. Take the next pill at the usual time, then take one pill per day in the order directed on the pack. Missing a pill by more than 12 hours increases your risk of becoming pregnant.

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 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 on 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.

Your risk of getting pregnant will increase with the number of pills you miss. If you miss a period for two months in a row, call your doctor because you might be pregnant. Use back-up birth control if you are not sure how many pills you have missed.

What happens if I overdose?

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

What should I avoid while using dienogest and estradiol?

Do not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills 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.

What are the possible side effects of dienogest and estradiol?

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;
• sudden severe headache, confusion, problems with vision, speech, or balance;
• sudden cough, wheezing, rapid breathing, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• jaundice (yellowing of the skin or eyes);
• 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, mood changes).

Less serious side effects may include:

• mild nausea or vomiting, appetite or weight changes;
• breast swelling or tenderness;
• headache, nervousness, dizziness;
• problems with contact lenses;
• freckles or darkening of facial skin, loss of scalp hair; or
• vaginal itching or discharge.

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.

What other drugs will affect dienogest and estradiol?

Many drugs can make birth control pills less effective, which may result in pregnancy. Below is just a partial list:

• antifungal medication (Sporanox, Extina, Ketozole, Nizoral, Vfend, and others);
• certain antibiotics (especially Biaxin, Ery-Tab, Erythrocin, Ketek, and others);
• certain antidepressants, or St. John's wort;
• certain HIV medications;
• certain seizure medications;
• isoniazid (for treating tuberculosis);
• St. John's wort;
• rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
• thyroid replacement (Synthroid, Levothroid, and others);
• phenobarbital or other barbiturates; or
• heart or blood pressure medication (especially Cartia, Cardizem, Cardene, Procardia, Calan, Covera, Isoptin, Verelan, and others).

This list is not complete and other drugs may interact with dienogest and estradiol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about dienogest and estradiol.