Estradiol/Norethindrone (By Mouth)

Estradiol (es-tra-DYE-ole), 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 this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to estradiol or norethindrone or if you are or may be pregnant. You should not use this medicine 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 this medicine if you have a history of stroke or certain types of cancer (especially breast cancer).

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine 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 This Medicine:

• 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 This Medicine:

• This medicine can cause severe birth defects in an unborn baby. Do not use this medicine while you are pregnant.
• If you are breastfeeding, talk to your doctor before using this medicine.
• 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.
• This medicine 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 this medicine. This is normal and should decrease over time.
• You should have regular check-ups with your doctor while you are using this medicine (usually every 6 to 12 months).
• This medicine 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 this medicine. 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 This Medicine:

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 this medicine, tell your doctor.