estradiol and norethindrone (oral)

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Pronunciation: ESS tra DYE ole and nor ETH in drone

Brand: Activella, Ena, Mimvey

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

Do not use if you are pregnant.

You should not use estradiol and norethindrone if you have had a hysterectomy, or if you have any of the following conditions: liver disease, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have recently had a heart attack, stroke, or a blood clot.

Estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Long-term use of this medicine may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risk.

Do not take this medicine in larger amounts or for longer than recommended.

What are estradiol and norethindrone?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and norethindrone is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes (itching, burning, dryness), and to prevent osteoporosis (bone loss) in menopausal women.

Estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking estradiol and norethindrone?

You should not use estradiol and norethindrone if you are allergic to it, or if you have:

  • a recent history of heart attack, stroke, or blood clots;
  • liver disease;
  • abnormal vaginal bleeding that a doctor has not checked;
  • a history of breast, uterine, or hormone-related cancer;
  • if you have had a hysterectomy; or
  • if you are pregnant.

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

  • heart disease;
  • risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);
  • asthma;
  • diabetes;
  • epilepsy or other seizure disorder;
  • migraines;
  • porphyria;
  • lupus;
  • kidney disease;
  • gallbladder disease;
  • endometriosis or uterine fibroid tumors;
  • a thyroid disorder; or
  • high levels of calcium in your blood.

Long-term use of estradiol and norethindrone may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using this medicine long term.

Estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

FDA pregnancy category X: Do not use estradiol and norethindrone if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Estradiol and norethindrone can pass into breast milk. This medication may slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take estradiol and norethindrone?

Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended.

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 estradiol and norethindrone.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using estradiol and norethindrone.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using estradiol and norethindrone?

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of estradiol and norethindrone?

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

Call your doctor at once if you have:

  • chest pain or heavy feeling, pain spreading to the jaw or shoulder, sweating, feeling short of breath, fainting;
  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • vomiting, jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding; or
  • a lump in your breast.

Common side effects may include:

  • nausea, bloating, stomach cramps;
  • headache, depressed mood;
  • breast pain, back pain;
  • sleep problems (insomnia);
  • hair loss, weight changes, acne; or
  • vaginal itching or discharge, breakthrough bleeding.

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 estradiol and norethindrone?

Other drugs may interact with estradiol and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about estradiol and norethindrone.

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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