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Estradiol and Norethindrone Tablets

Generic Name: Estradiol and Norethindrone Tablets (ES tra DYE ol and nor ETH in drone)
Brand Name: Activella

  • Estrogens may raise the chance of endometrial cancer (cancer of the lining of the uterus).
  • Do not use estrogens to prevent heart disease or dementia. Using estrogens may raise the chances of having a heart attack, a stroke, breast cancer, a blood clot, or dementia.
  • Use estrogens with or without progestin for the shortest time needed at the lowest useful dose.

Uses of Estradiol and Norethindrone Tablets:

  • It is used to put off soft, brittle bones (osteoporosis) in women after change of life.
  • It is used to prevent or lower the signs of the change of life (menopause).
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Estradiol and Norethindrone Tablets?

  • If you have an allergy to estradiol, norethindrone, or any other part of this medicine (estradiol and norethindrone tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have had any of these health problems: Bleeding disorder, blood clots, a higher risk of having a blood clot, breast cancer, liver problems or liver tumor, heart attack, stroke, or a tumor where estrogen makes it grow.
  • If you have unexplained vaginal bleeding.
  • If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.

This is not a list of all drugs or health problems that interact with this medicine (estradiol and norethindrone tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Estradiol and Norethindrone Tablets?

  • Tell all of your health care providers that you take this medicine (estradiol and norethindrone tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • Check your blood sugar as you have been told by your doctor.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • Limit your drinking of alcohol.
  • Avoid cigarette smoking. Smoking raises the chance of heart disease. Talk with your doctor.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
  • Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
  • If you are 65 or older, use this medicine (estradiol and norethindrone tablets) with care. You could have more side effects.
  • This medicine is not approved for use in children. Talk with the doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Soft, brittle bones (osteoporosis):

  • This medicine works best when used with calcium/vitamin D and weight-bearing workouts like walking or PT (physical therapy).
  • Follow the diet and workout plan that your doctor told you about.

How is this medicine (Estradiol and Norethindrone Tablets) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take this medicine (estradiol and norethindrone tablets) at the same time of day.
  • Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses or extra doses.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Chest pain or pressure.
  • Shortness of breath.
  • Coughing up blood.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Very bad headache.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Very bad dizziness or passing out.
  • Change in eyesight.
  • Bulging eyes.
  • Change in how contact lenses feel in the eyes.
  • A lump in the breast, breast soreness, or nipple discharge.
  • Breast pain.
  • Vaginal itching or discharge.
  • Vaginal bleeding that is not normal.
  • Low mood (depression).
  • Memory problems or loss.
  • Swelling.

What are some other side effects of Estradiol and Norethindrone Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Hair loss.
  • Upset stomach or throwing up.
  • Cramps.
  • Bloating.
  • Tender breasts.
  • Enlarged breasts.
  • Vaginal bleeding or spotting.
  • This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Estradiol and Norethindrone Tablets?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine (estradiol and norethindrone tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine (estradiol and norethindrone tablets). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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