Dienogest and estradiol

What is Dienogest and estradiol?

Dienogest with estradiol, a combination of female hormones, prevents ovulation. Dienogest and estradiol can also cause changes to your cervical mucus and uterine lining and make it more difficult for sperm and fertilized eggs to attach to your uterus. Dienogest is combined with estradiol to prevent pregnancy. This medicine can also be used to treat excessive menstrual blood flow, which is not due to any medical conditions of the uterus. This medication guide does not list all possible uses for estradiol and dienogest.

Side effects of Dienogest and estradiol

If you experience any of the following signs and symptoms of an allergic reaction: difficulty breathing, hives or swelling to your lips, face, tongue or throat. Seek medical help immediately.

If you experience:

• Signs of stroke: sudden numbness, weakness, or headache (especially one side), slurred or shaky speech, or problems with vision, balance, or coordination;
• Signs of a blood clot: chest pain, sudden coughing, wheezing or coughing blood, swelling in the legs, or warmth;
• Heart attack symptoms: chest pain or pressure; pain spreading into your jaw or shoulder; nausea and sweating.
• Liver problems: severe stomach pains, fatigue, dark urine, clay-colored stools, and jaundice
• Sudden and severe pelvic pain
• A change in the frequency or intensity of migraine headaches
• You may experience swelling of your ankles, feet, or hands.
• Breast lumps;
• Symptoms of depression include sleep problems, fatigue, and mood changes.

Dienogest, estradiol, and their side effects include:

• Light vaginal bleeding;
• Vomiting, nausea (especially in the first few weeks of taking this medication), nausea
• Breast pain or tenderness
• Weight gain
• Contact lenses are causing problems.

There may be other side effects. Call your physician if experiencing symptoms. To report side effects to the FDA directly, call their toll free number at 1-800-FDA-1088.

Warnings

Avoid using dienogest or estradiol while pregnant or after a recent birth. If you are suffering from uncontrolled high blood tension, heart disease, a bleeding disorder, diabetes, problems with the eyes or kidneys, unusual vaginal blood, liver cancer or disease, severe headaches, or migraines, you should not use this medication. This medicine may increase your risk of blood clots or strokes. It is especially dangerous if you suffer from certain conditions or are overweight. Smoking increases your risk of blood clots and strokes. If you are older than 35 and smoke, it is not recommended that you take estradiol and dienogest. If you miss a pill, your chances of getting pregnant increase. If you forget to take a medicine, carefully follow the instructions for "missed dosage".

Before you take this drug

This medicine increases your risk of stroke, heart attack, and blood clots. If you have diabetes, high blood pressure, high cholesterol, or are overweight, you're at an even greater risk. The risk of stroke and blood clots is greatest during the first year you take dienogest with estradiol. You are at high risk if you start taking this medication after a break of 4 weeks or more. Smoking increases your risk of blood clots and strokes. The more you smoke, the greater the risk. This medicine should not be taken if you are older than 35 and smoke. Do not use this medication if pregnant. Tell your doctor immediately if you are pregnant or if two menstrual cycles are missed in a row. Wait at least four weeks after giving birth before you take this medication.

If you are:

• Untreated or uncontrolled hypertension;
• Heart disease (coronary arterial disease, uncontrolled heart-valve disorder, history of stroke, blood clot, or heart attack);
• A blood-clotting disorder or circulation problems;
• Diabetes can cause problems with the eyes, kidneys, and circulation.
• A history of cancers related to hormones, such as breast cancer or uterine carcinoma;
• Unusual vaginal bleeding not being addressed by a healthcare provider:
• Liver disease or liver cancer
• Migraine headaches can be severe.
• If you are older than 35 and smoke, then this is for you.

Tell your doctor about any of the following to ensure that this medication is safe for you:

• If you have high blood pressure, high cholesterol, or high triglycerides, or if your weight is high,
• A history of depression
• Gallbladder diseases, and diabetes.
• Seizures or epilepsy;
• A history of jaundice due to pregnancy or birth-control pills

Dienogest, estradiol, and other hormones can be passed into breast milk. This may cause harm to a nursing infant. This medicine can also reduce breast milk production. Use caution if you plan to breastfeed your baby.

How to take Dienogest and estradiol?

Dienogest estradiol comes in five different colors. Take one pill every day, in the exact sequence shown on the blister. Follow the arrows on each row of the pills. For the first nine days, use a backup birth control such as a condom or spermicide. Take no more than one type of birth control pill at a time. Start taking estradiol and dienogest on the first day of your period if you're switching from another pill. Start taking estradiol and dienogest on the day that you would normally take your next pill if you had been taking only progestin pills. Start taking dienogest and estradiol the day after the removal of the previous birth control device. Start taking dienogest on the same day as your next scheduled birth control injection if you're switching from an injection.

Inform your doctor if bleeding occurs at the beginning of a period. It is possible to have no or very little bleeding during your period. You may have to temporarily stop taking this medication if you are going to be undergoing medical tests, surgery, or bed rest. You should let any doctor or surgeon that treats you know you're using estradiol and dienogest. You will need to see your doctor regularly while taking estradiol and dienogest. Store away from heat and moisture at room temperature.

Details on dosage

Adult dose for contraception:

Take one tablet every day at the same time.
The tablets must be taken according to the instructions on the blister package.
Comments:
The effectiveness of the product in women with an anthropometric index greater than 30 kg/m2 was not evaluated.
Start with the first pill taken on the day of your menstrual period. Use non-hormonal contraceptives for the next 9 days.
If you have not had a period, it is best to rule out pregnancy. Non-hormonal contraceptives can be used during the first nine days.
If you are switching from another hormonal combination method, take the first pill the day after withdrawal bleeding. If no withdrawal bleeding occurs, rule out pregnancy.
Switching from transdermal patches or vaginal rings: Take your first pill the day after the patch or ring is removed. Non-hormonal backup contraceptives are recommended for the first nine days.
Switching from a progestin-only method: Take your first pill the day after the last progestin pill, the day you remove an implant or receive the next injection. Use non-hormonal backup contraceptives for the first nine days.
Uses:
-Pregnancy prevention
Treatment of heavy menstrual bleeds without organic pathology among women who use oral contraceptives as contraception

What happens if I miss the dose?

Please read and follow all instructions that accompany your medication, if there are any unclear portions contact your pharmacist for clarification or call your physician to inquire further. If necessary seek additional help from either. You are more likely to become pregnant if you miss a pill for longer than 12 hours. Vomiting or diarrhea that occurs within four hours of taking a dose is considered to be the same thing as missing it.

You will miss one pill if you:

• On Days 1–17, take the missed pill immediately after you remember it. Then take the next pill at your usual time. Use a backup birth control method for at least nine days.
• On Days 18–24, throw away the remaining pack and begin a new one on the same day. Start with the Day 1 pill in the new pack, and take one pill each day according to the instructions on the package. Use backup birth control for at least 9 days.
• Take the missed pill immediately after you remember it. Then, take your next pill as usual. If you miss a pill between Days 25 and 28, you do not require backup birth control.

If you miss two pills:

• On Days 1–16, skip the missed doses and begin with the next pill. Take one pill per dose in the same order as directed on the package. Use your backup birth control for a minimum of 9 days.
• On Days 17 to 24, discard the remaining pack and begin a new one on the same day. Start with the Day 3 pill in the new pack, and take it one pill a day according to the instructions on the package. Use your backup birth control for a minimum of 9 days.
• Throw out the remainder of the pack during Days 25 to 28. Start a brand new pack the next day, or the day that you normally would. Take one pill daily in the prescribed order. There is no need for a backup birth control method.

Call your doctor if you have missed two periods in a row. You might be pregnant.

What happens if I overdose?

Call the Poison Help Line at 1-800-222-1222, or seek emergency medical attention if overdose symptoms such as nausea, vomiting and vaginal bleeding appear.

What should be avoided?

Do Not Smoke While Taking Dienogest or Estradiol, Especially if You Are Over 35 Years Old. Estradiol and dienogest will not protect you against sexually transmissible diseases, including HIV and AIDS. The only way to prevent these diseases is by using a condom.

Interaction with other drug

Birth control pills can be affected by many drugs, causing them to become less effective and resulting in pregnancy. Estradiol may also reduce the effectiveness of other drugs or increase side effects. You may have to use an alternative birth control method if you are taking certain drugs. Inform your doctor of all the medications you are taking and those that you have started or stopped using. This medication guide does not list all possible interactions.