Estradiol is a form of estrogen. Estrogen is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Together, estradiol and norethindrone are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes” or "hot flushes”); to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause; and to replace estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure that result in a lack of estrogen. Estradiol and norethindrone is also used to prevent thinning of the bones (osteoporosis).

Estradiol and norethindrone may also be used for purposes other than those listed in this medication guide.

Take estradiol and norethindrone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a glass of water.

Try to take each dose at the same time every day.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norethindrone.

Store ethinyl estradiol and norethindrone tablets at room temperature away from moisture, heat, and direct light.

Before taking estradiol and norethindrone, tell your doctor if you are taking an anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to take estradiol and norethindrone, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with estradiol and norethindrone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

There are no restrictions on food, beverages, or activity while taking estradiol and norethindrone unless otherwise directed by your doctor.

Contact an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of a estradiol and norethindrone overdose may include nausea, vomiting, and withdrawal bleeding may occur in females.

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norethindrone.

Do not take estradiol and norethindrone without first talking to your doctor if you have

• a circulation, bleeding, or blood-clotting disorder;

• undiagnosed, abnormal vaginal bleeding;

• any type of breast, uterine, or hormone-dependent cancer; or

• liver disease.

Taking estradiol and norethindrone may be dangerous in some cases if you have any of the conditions listed above.

Before taking estradiol and norethindrone, tell your doctor if you have

• high blood pressure, angina, or heart disease;

• high levels of cholesterol or triglycerides in your blood;

• kidney disease;

• asthma;

• epilepsy;

• migraines;

• depression;

• diabetes;

• gallbladder disease;

• uterine fibroids; or

• had a hysterectomy (uterus removed).

You may not be able to take estradiol and norethindrone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Estradiol and norethindrone is in the FDA pregnancy category X. This means that estradiol and norethindrone is known to cause birth defects in an unborn baby. Do not take estradiol and norethindrone if you are pregnant or could become pregnant during treatment.

Estradiol and norethindrone may decrease milk flow and have other effects on milk composition. Do not take estradiol and norethindrone without first talking to your doctor if you are breast-feeding a baby.

Your pharmacist has additional information about estradiol and norethindrone written for health professionals that you may read.

Estradiol and norethindrone is available with a prescription under the brand name Activella in a tablet formulation. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Activella (1mg estradiol and 0.5 mg norethindrone)-white, round tablet