Medications and Drugs

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Brand Names: Natazia

Generic Name: dienogest and estradiol (Pronunciation: dye EN oh jest and ESS tra DYE ole)

• What is dienogest and estradiol (Natazia)?
• What are the possible side effects of dienogest and estradiol (Natazia)?
• What is the most important information I should know about dienogest and estradiol (Natazia)?
• What should I discuss with my healthcare provider before using dienogest and estradiol (Natazia)?
• How should I take dienogest and estradiol (Natazia)?
• What happens if I miss a dose (Natazia)?
• What happens if I overdose (Natazia)?
• What should I avoid while using dienogest and estradiol (Natazia)?
• What other drugs will affect dienogest and estradiol (Natazia)?
• Where can I get more information?

What is dienogest and estradiol (Natazia)?

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 are the possible side effects of dienogest and estradiol (Natazia)?

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 is the most important information I should know about dienogest and estradiol (Natazia)?

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

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.

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