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progesterone-oral (cont.)

PRECAUTIONS: Tell your doctor your medical history (and family history), especially of: allergies (especially to drugs or peanuts), heart disease, kidney disease, liver disease, abnormal vaginal bleeding, cancer, blood clots/blood vessel problems, strokes, missed abortion, any conditions you had that worsened because of pregnancy or sex steroid use (e.g., norethindrone, progesterone). Two-drug combination hormone replacement therapy (estrogen and progestin menopause HRT) can infrequently cause cancer of the breast, heart disease (e.g., heart attack), stroke, dementia, and blood clots in the lung (pulmonary embolism) or leg. Estrogens may also increase the risk of cancer of the ovary. These risks appear to depend on the length of time this combination is used and the amount of estrogen per dose. Therefore, two-drug HRT should be used for the shortest possible length of time at the lowest effective dose, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Discuss the risks and benefits with your doctor. If you use this drug for an extended period, you should be evaluated at least once a year. See Notes section. 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. Limit alcohol consumption as it may increase the side effects of this drug. Because this medication may cause drowsiness, use caution performing tasks requiring alertness (e.g., driving). This drug should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially of drugs that can cause drowsiness such as: sedatives, drugs for sleep, anti- anxiety drugs, anti-seizure medicines, narcotic pain relievers (e.g., codeine), psychiatric medications, muscle relaxants, certain antihistamines (e.g., diphenhydramine). Certain laboratory tests may be altered by this drug, such as gonadotropin, progesterone and pregnanediol. Do not start or stop any medicine without doctor or pharmacist approval.




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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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