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.

ESTROGEN/PROGESTINS - ORAL

WARNING: Combination hormone replacement therapy (estrogen and progestin HRT) should not be used to prevent heart disease. Two-drug combination hormone replacement therapy 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.

USES: This medication is a combination of hormones (estrogen and progestin) used to treat symptoms of menopause (e.g., hot flashes, vaginal dryness) and to prevent bone loss (osteoporosis) in people at high risk. If you are only being treated for vaginal menopause symptoms, products applied locally such as vaginal creams, tablets, or rings should be considered before products taken by mouth or absorbed through the skin. 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.

HOW TO USE: Take this medication by mouth at the same time each day, usually once daily. It may be taken with food or immediately after a meal to prevent stomach upset. Do not increase your dose, take it more often than directed, or stop taking it without first consulting your doctor. Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, fatigue, nausea, weight changes, increased/decreased interest in sex, and breast tenderness may occur. If any of these persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), calf pain/swelling, sudden severe headache, chest pain, trouble breathing, one-sided weakness, slurred speech, vision changes (e.g., change in contact lens fit, loss of vision), breast lumps, swelling of hands and feet, changes in vaginal bleeding (e.g., spotting, breakthrough bleeding or prolonged bleeding), unusual vaginal discharge/itching/odor, yellowing of the eyes or skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. 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: undiagnosed abnormal vaginal bleeding, cancer (e.g., of the breast or ovary), blood clots, active/recent stroke or heart attack, liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, heart attacks, congestive heart failure), kidney disease, low thyroid hormone (hypothyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy (toxemia), yellowing of eyes and skin (cholestatic jaundice) during pregnancy or with past estrogen use, womb problems (e.g., uterine fibroids, endometriosis), cholesterol or lipid problems, gallbladder disease, excessive weight gain, certain blood disorder (porphyria), any allergies. If you will be having surgery or will be confined to a chair or bed for a long period of time (e.g., a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. Cigarette smoking can increase the chance of blood clots while taking this medication (especially in women over the age of 35). This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: corticosteroids (e.g., prednisone), hydantoins (e.g., phenytoin), warfarin, drugs which affect certain liver enzymes (CYP450-3A4 enzymes) such as azole antifungals (e.g., ketoconazole, itraconazole), carbamazepine, macrolide antibiotics (e.g., clarithromycin, erythromycin), phenobarbital, rifamycins (e.g., rifampin), ritonavir, cimetidine, St. John's Wort. This product can affect the results of certain lab 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: severe nausea/vomiting or excessive vaginal bleeding.

NOTES: Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. You should also have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Non-drug therapy to help prevent bone loss includes a weight-bearing exercise plan and adequate daily calcium and vitamin D. Consult your doctor or pharmacist for more details.

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 at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 to 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

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