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Brand Names: Combipatch

Generic Name: estradiol and norethindrone (topical patches) (Pronunciation: ess tra DYE all and nor ETH in drone)

• What are estradiol and norethindrone (CombiPatch)?
• What are the possible side effects of estradiol and norethindrone (CombiPatch)?
• What is the most important information I should know about estradiol and norethindrone (CombiPatch)?
• What should I discuss with my healthcare provider before using estradiol and norethindrone (CombiPatch)?
• How should I use estradiol and norethindrone (CombiPatch)?
• What happens if I miss a dose (CombiPatch)?
• What happens if I overdose (CombiPatch)?
• What should I avoid while using estradiol and norethindrone (CombiPatch)?
• What other drugs will affect estradiol and norethindrone (CombiPatch)?
• Where can I get more information?

What are estradiol and norethindrone (CombiPatch)?

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

What are the possible side effects of estradiol and norethindrone (CombiPatch)?

Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side effects, stop using estradiol and norethindrone and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• sharp chest pain, coughing of blood or shortness of breath (possible blood clot in the lung );
• pain in the calf (possible blood clot in the leg);
• crushing chest pain or heaviness in the chest (possible heart attack);
• sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (possible stroke);
• partial or complete loss of vision (possible clot in the eye);
• stomach pain or tenderness, yellowing of the skin or eyes, fever, fatigue, loss of appetite, dark-colored urine, or light-colored stools (possible liver problems); or
• new or changing breast lumps.

Other, less serious side effects may be more likely to occur. Continue to use estradiol and norethindrone and talk to your doctor if you experience

• nausea and vomiting;
• tenderness or enlargement of the breasts;
• weakness;
• swelling of the hands or feet;
• spotty darkening of the skin, particularly on the face;
• difficulty in wearing contact lenses;
• vaginal irritation or discomfort;
• a rash or reaction at the patch application site; or
• changes in menstrual cycle, painful menstruation, or breakthrough bleeding.

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.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about estradiol and norethindrone (CombiPatch)?

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.

Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

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

Do not use this medication if you are pregnant.

Do not place the transdermal patch on your breasts or at your waistline where tight-fitting clothing may interfere with its functioning.