Estradiol and norethindrone transdermal

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 transdermal (skin patch) is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes (itching, burning, dryness). This medicine is also used before menopause to treat a lack of estrogen caused by conditions such as hypogonadism, primary ovarian failure, or surgical removal of the ovaries.

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

You should not use this medicine if you are allergic to estradiol or norethindrone, or if you have:

• a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

• liver disease;

• abnormal vaginal bleeding that has not been checked by a doctor;

• a history of breast, uterine, or hormone-related cancer;

• a bleeding or blood-clotting disorder;

• if you have had a hysterectomy; or

• if you are pregnant or may become pregnant.

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 may also increase your risk of breast cancer or blood clot. Talk with your doctor about your individual risks before using this medicine long-term.

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

• unusual vaginal bleeding;

• heart disease;

• risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease);

• liver or kidney disease;

• hereditary angioedema;

• lupus;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• porphyria;

• gallbladder disease;

• endometriosis or uterine fibroid tumors;

• a thyroid disorder; or

• high levels of calcium levels in your blood (hypercalcemia).

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 medicine may slow breast milk production. Do not use if you are breast-feeding a baby.

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

In the U.S.

• Combipatch

In Canada

• Estalis
• Estalis-Sequi

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Estrogen/Progestin Combination

Pharmacologic Class: Estrogen