ESTRADIOL/NORETHINDRONE-ORAL (cont.)
PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease, history of blood clots (thrombophlebitis), blood vessel problems (e.g., cerebral vascular disease, coronary artery disease), stroke, history of certain cancers (especially endometrial or breast cancer), unusual vaginal bleeding of unknown cause, pregnancy, heavy smoking. Tell your doctor your medical history (including family history), especially of: heart problems, gallbladder disease, diabetes, high cholesterol or triglyceride levels, high blood pressure (hypertension), asthma, migraines, seizures, mental/mood changes (e.g., depression, memory loss), eye or vision problems, high calcium levels (hypercalcemia), thyroid problems, any allergies. Two-drug combination hormone replacement therapy (estrogen and progestin menopause HRT) can infrequently cause breast cancer, heart disease (CHD/MI), stroke, dementia, and blood clots in the lung (PE) or leg, especially if used for a long period of time (greater than one year). Therefore, the risks of use of HRT for a long period of time must be discussed with your doctor . Use of two-drug HRT for short periods of time (less than one year) to relieve menopause symptoms may be considered. Discuss the risks and benefits with your doctor. Blood clots may be more likely to form during very long periods of sitting or if you are bedridden, as well as with certain types of surgery. If this applies to you, ask your doctor whether you should temporarily stop your medication. If you are near-sighted or wear contact lenses, you may develop vision problems or have trouble wearing your contact lenses. Contact your eye doctor if this occurs. Do not smoke cigarettes. This medication combined with smoking cigarettes, especially in women older than 35 years of age, puts you at a much higher risk of developing serious health problems than with this medication alone. Consult your doctor or pharmacist for more information. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk and has had undesirable effects on nursing infants. Consult your doctor before breast- feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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