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Esterified Estrogens/Methyltestosterone is used for:

Treating symptoms of menopause in patients who do not respond to estrogens used alone. It may also be used for other conditions as determined by your doctor.

Esterified Estrogens/Methyltestosterone includes 2 naturally occurring hormones, an estrogen and an androgen. It is used to treat symptoms of menopause in women whose bodies do not produce enough of these hormones.

Do NOT use Esterified Estrogens/Methyltestosterone if:

• you are allergic to any ingredient in Esterified Estrogens/Methyltestosterone
• you have blood clots or a history of blood clots, unexplained or abnormal vaginal bleeding,an estrogen-dependent tumor, breast cancer, severe liver damage, or porphyria (a blood disorder),or if you are pregnant, think you may be pregnant, or are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Esterified Estrogens/Methyltestosterone :

Some medical conditions may interact with Esterified Estrogens/Methyltestosterone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had an abnormal mammogram (breast x-ray); a lump in your breast; heart problems; lupus; diabetes; endometrial cancer or endometriosis; blood flow problems; liver or kidney problems; gallbladder disease; high cholesterol, lipid, triglyceride, or calcium levels; high blood pressure; yellowing of the skin or eyes; inflammation of the pancreas; or tumors on your uterus; if you are obese; or if you have recently had or will be having surgery
• if you smoke cigarettes

Some MEDICINES MAY INTERACT with Esterified Estrogens/Methyltestosterone . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Esterified Estrogens/Methyltestosterone 's effectiveness
• Anticoagulants (eg, warfarin), carbamazepine, corticosteroids (eg, hydrocortisone), cyclosporine, macrolide immunosuppressants (eg, tacrolimus), succinylcholine, or tricyclic antidepressants (eg, amitriptyline) because their actions and the risk of their side effects may be increased by Esterified Estrogens/Methyltestosterone
• Anticoagulants (eg, warfarin) or tricyclic antidepressants (eg, amitriptyline) because their effectiveness may be decreased by Esterified Estrogens/Methyltestosterone
• Tricyclic antidepressants (eg, amitriptyline) because a paranoid reaction may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Esterified Estrogens/Methyltestosterone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Esterified Estrogens/Methyltestosterone :

Use Esterified Estrogens/Methyltestosterone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Esterified Estrogens/Methyltestosterone by mouth with or without food.
• Esterified Estrogens/Methyltestosterone should be used for the shortest possible length of time for you to obtain the benefits. This minimizes the chance of serious side effects from long-term treatment.
• If you miss a dose of Esterified Estrogens/Methyltestosterone , take it as soon as possible that same day. If it is almost time for your next dose or it is the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use this medicine.

Important safety information:

• Esterified Estrogens/Methyltestosterone may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Esterified Estrogens/Methyltestosterone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Esterified Estrogens/Methyltestosterone may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
• Follow your doctor's instructions to examine your breasts, and report any lumps to your health care provider immediately.
• If you are having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks in advance. Special precautions may be needed.
• Esterified Estrogens/Methyltestosterone may cause dark skin patches on your face. Sun exposure may make these patches darker. If patches develop, use sunscreen or protective clothing when exposed to sun, sunlamps, or tanning booths.
• Diabetes patients - Esterified Estrogens/Methyltestosterone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests may be performed while you use Esterified Estrogens/Methyltestosterone . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Esterified Estrogens/Methyltestosterone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Esterified Estrogens/Methyltestosterone if you are pregnant. It may cause birth defects. Avoid becoming pregnant while you are taking it. Use nonhormonal birth control measures (eg, condoms) while taking Esterified Estrogens/Methyltestosterone . If you think you may be pregnant, contact your doctor right away. It is not known if Esterified Estrogens/Methyltestosterone is found in breast milk. Do not breast-feed while taking Esterified Estrogens/Methyltestosterone .

Possible side effects of Esterified Estrogens/Methyltestosterone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensation; acne; bloating; breast enlargement; changes in sex drive; cramps; deepening of voice; fluid retention; headache; loss of scalp hair; nausea; premenstrual syndrome (PMS); spotty dark patches on the face; unusual body hair growth; unusual body movements.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding or spotting; breast tenderness or secretion; calf or chest pain; changes in menstrual flow; changes in vision; coughing up blood; dark urine; difficulty wearing contact lenses; dizziness or fainting; facial hair; lumps in the breast; memory loss; mental/mood changes; migraine (sudden severe headache); shortness of breath; slurred speech; stomach pain, swelling, or tenderness; swelling of the fingers, legs, and ankles; vaginal infection; vomiting; weakness on one side of the body; weight changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea; vomiting; withdrawal bleeding.

Store Esterified Estrogens/Methyltestosterone at room temperature , between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Esterified Estrogens/Methyltestosterone out of the reach of children and away from pets.

General information:

• If you have any questions about Esterified Estrogens/Methyltestosterone , please talk with your doctor, pharmacist, or other health care provider.
• Esterified Estrogens/Methyltestosterone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Esterified Estrogens/Methyltestosterone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.