IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ESTRADIOL/NORETHINDRONE - ORAL

(ess-truh-DYE-all/nor-ETH-in-drone)

COMMON BRAND NAME(S): Activella

USES: This combination estrogen/progesterone hormone replacement therapy (HRT) medication is used to treat various female medical conditions caused by a natural decrease in these hormones (e.g.,"hot flashes" with menopause, vaginal/vulvar dryness), as well as to prevent bone loss (osteoporosis). There are several medications (e.g., raloxifene or bisphosphonates) that are safe and effective to prevent or treat bone loss. These medicines should be considered for use before estrogen/progestin HRT therapy for osteoporosis. If you have other medical conditions as well, and are prescribed estrogen/progestin HRT for more than one condition, consult your doctor about your treatment plan and its options. Combination HRT should not be used to prevent heart disease. This medication is not recommended for women who have had their uterus removed (hysterectomy). Estrogen hormones alone are recommended in those cases.

OTHER USES: This drug may also be used to regulate your menstrual cycle.

HOW TO USE: Take this medication by mouth usually once daily, or as directed by your doctor. Try to take this medication at the same time each day. Doing so may help you to remember to take it. This medication should be used for the shortest possible length of time, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.

SIDE EFFECTS: Nausea, vomiting, headache, diarrhea, unusual weight change (gain or loss), swelling or bloating, skin spots, hair loss, breast tenderness, or difficulty wearing contact lenses may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: unusual or severe vaginal bleeding, dizziness, flu- like symptoms (e.g., fever, cough, unusual weakness/fatigue, sore throat, muscle aches), mental/mood changes, trouble sleeping, vaginal infections. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe headache, pain/swelling in the legs, pain in the groin, trouble breathing, chest pain, vision changes, severe stomach pain, one-sided weakness, slurred speech, yellowing eyes or skin, lumps in the breast. If you notice other effects not listed above, contact your doctor or pharmacist.

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.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: corticosteroids (e.g., prednisone, prednisolone), rifamycins (e.g., rifampin), certain anti-seizure drugs (e.g., phenobarbital, phenytoin). This product can affect the result of certain lab tests (e.g., liver function tests, blood tests). Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea, vomiting, vaginal bleeding.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., potassium levels, breast exams, pelvic exams) should be performed to monitor for serious side effects. The breast exams should be monthly (self exam) and yearly (professional exam). A manufacturer's fact sheet about this drug should be dispensed with each prescription. Read the information carefully; if any of the information is unclear, consult your doctor or pharmacist.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule; do not double the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.

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Copyright 2004 by First DataBank, Inc.