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If you experience any of the following serious side effects, stop taking 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), shortness of breath or pain in the chest, a painful, red, swollen leg, abnormal vaginal bleeding, pain, swelling, or tenderness in the abdomen, severe headache or vomiting, dizziness, faintness or changes in vision or speech, yellowing of the skin or eyes, or a lump in a breast. Other, less serious side effects may be more likely to occur. Continue to take 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 or changes in menstrual cycle, painful menstruation, or break-through 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. It is unclear to what extent estrogen and progesterone treatments may affect the risk of breast cancer.

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. Prevention of Postmenopausal Osteoporosis