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= Prescription Required = Generic Equvalent

Estradiol/Norethindrone Acetate

Activella - Called Kliovance
1/0.5mg Tablets
Estradiol/Norethindrone Acetate

Estradiol/Norethindrone Acetate Information

Estradiol/Norethindrone (By mouth)
Estradiol (es-tra-DYE-ol), Norethindrone (nor-ETH-in-drone)

Treats symptoms of menopause, including hot flashes, night sweats, and vaginal dryness and irritation. Estradiol is a type of estrogen. Norethindrone is a type of progestin.

Brand Name(s):Activella
There may be other brand names for Estradiol/Norethindrone Acetate.

When Estradiol/Norethindrone Acetate Should Not Be Used:
You should not use Estradiol/Norethindrone Acetate if you have had an allergic reaction to estradiol or norethindrone or if you are or may be pregnant. You should not use Estradiol/Norethindrone Acetate if you have blood clotting problems, liver disease, unexplained vaginal bleeding, or if you have or suspect you have certain types of cancer (including breast or endometrial cancer). Also, you should not use Estradiol/Norethindrone Acetate if you have a history of stroke or certain types of cancer (especially breast cancer).

How to Use Estradiol/Norethindrone Acetate:
Tablet

Your doctor will tell you how much of Estradiol/Norethindrone Acetate to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
Estradiol/Norethindrone Acetate sometimes comes in a special dispenser pack with a calendar reminder dial. To use this dispenser, first turn the inner disc so the current day of the week is lined up with the plastic tab. Pull the plastic tab up and break if off. Tip out the first tablet.
To get the next tablet out (on the next day), turn the outer transparent dial one space clockwise as shown by the arrow.
The transparent dial can be turned only after the tablet in the opening has been removed. This will help you to remember to take one tablet every day.

If a dose is missed:

Use your medicine as soon as possible unless it is almost time for your next dose.
Skip the missed dose if it is almost time for your next regular dose.
Do not use two doses at the same time.

How to Store and Dispose of Estradiol/Norethindrone Acetate:

Store at room temperature in a closed container, away from heat, moisture, and direct light.
Keep this and all medicine out of the reach of children.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using Estradiol/Norethindrone Acetate:

Estradiol/Norethindrone Acetate can cause severe birth defects in an unborn baby. Do not use Estradiol/Norethindrone Acetate while you are pregnant.
If you are breastfeeding, talk to your doctor before using Estradiol/Norethindrone Acetate.
Make sure your doctor knows if you have heart disease, circulation problems, diabetes, asthma, epilepsy, migraine headaches, or kidney problems. Also make sure your doctor knows if you feel depressed or have a history of depression.
Estradiol/Norethindrone Acetate is intended to be used only by women who have an intact uterus (womb). Tell your doctor if you have had a hysterectomy (had your uterus removed).
You may have irregular vaginal bleeding or spotting when you first start using Estradiol/Norethindrone Acetate. This is normal and should decrease over time.
You should have regular check-ups with your doctor while you are using Estradiol/Norethindrone Acetate (usually every 6 to 12 months).
Estradiol/Norethindrone Acetate may increase your risk for developing breast cancer or cancer of the uterus, especially with long-term use or large doses. Be sure to discuss this with your doctor.
You can help combat breast cancer by doing regular breast self-exams (at any age) and having regular mammograms (if you are over 40). Ask your doctor if you do not know how to do a breast self-exam.
Be sure you understand all the advantages and disadvantages of treatment with Estradiol/Norethindrone Acetate. Estrogen taken alone (without the progestin) has been know to cause endometrial cancer and heart, blood pressure, gallbladder, and circulation problems. Discuss this with your doctor.

Possible Side Effects While Using Estradiol/Norethindrone Acetate:
Call your doctor right away if you notice any of these side effects:

Moderate to heavy vaginal bleeding
Pelvic pain, discomfort, aching, or heaviness
Sudden chest pain, trouble breathing, or coughing up blood
Sudden severe headache, dizziness, change in speech, or weakness
Sudden vision problems, including complete or partial loss of vision or double vision, or protruding eyeballs
Swelling or pain in leg
Yellow eyes or skin

If you notice these less serious side effects, talk with your doctor:

Breast tenderness or pain
Light vaginal bleeding or spotting
Nausea, vomiting
Trouble sleeping

If you notice other side effects that you think are caused by Estradiol/Norethindrone Acetate, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088