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EstroGel Gel is used for:

Treating vulvar and vaginal atrophy, as well as other conditions due to menopause (eg, hot flashes, vaginal itching, burning, or dryness).

EstroGel Gel is an estrogen hormone used to provide the female hormone when the body no longer produces enough.

Do NOT use EstroGel Gel if:

• you are allergic to any ingredient in EstroGel Gel
• you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus
• you have known or suspected breast cancer (unless directed by your doctor) or you have cancers that are estrogen-dependent
• you have blood clots, circulation disorders, or liver problems
• you have had a recent heart attack or stroke

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

Before using EstroGel Gel:

Some medical conditions may interact with EstroGel Gel. 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
• 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 a family history of breast cancer, or you have breast lumps or disease, or an abnormal mammogram
• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
• if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
• if you have abnormal calcium levels in the blood, asthma, cancer, certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
• if you smoke or will be having surgery

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

• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by EstroGel Gel
• Anticoagulants (eg, warfarin) because their effectiveness may be decreased by EstroGel Gel
• Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease EstroGel Gel's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if EstroGel Gel 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 EstroGel Gel:

Use EstroGel Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with EstroGel Gel. Talk to your pharmacist if you have questions about this information.
• If you are switching from oral estrogen to EstroGel Gel, stop taking the oral estrogen and wait 1 week before using EstroGel Gel. However, if symptoms return, you may start using EstroGel Gel sooner.
• Wash your hands with soap and water both before and after using EstroGel Gel.
• Be sure your skin is completely dry before applying EstroGel Gel. Press the pump firmly and fully to dispense the medicine into the palm of your hand. Spread the medicine as thinly as possible over the entire area on the inside and outside of your arm from the wrist to the shoulder. Allow the medicine to dry for 5 minutes.
• Grapefruit and grapefruit juice may increase the risk of EstroGel Gel's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking EstroGel Gel.
• If you miss a dose of EstroGel Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use EstroGel Gel.

Important safety information:

• EstroGel Gel may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use EstroGel Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Limit alcoholic beverages while you are using EstroGel Gel.
• EstroGel Gel may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
• EstroGel Gel may increase the risk of blood clots. The risk may be greater if you smoke. (especially in women older than 35 years of age).
• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking EstroGel Gel.
• Follow your doctor's instructions for examining your breasts, and report any lumps immediately.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you will be 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 beforehand. Special precautions may need to be taken in these circumstances while you are taking EstroGel Gel.
• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
• EstroGel Gel may increase the risk of breast and endometrial cancer.
• Diabetes patients - EstroGel Gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• EstroGel Gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using EstroGel Gel.
• Lab tests, including physical exams and blood pressure, may be performed while you use EstroGel Gel. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
• EstroGel Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use EstroGel Gel if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. EstroGel Gel may be found in breast milk. If you are or will be breast-feeding while you use EstroGel Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of EstroGel Gel:

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:

Breast pain or tenderness; headache; hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain;breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes; vomiting; weakness or numbness of an arm or leg; 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 excessive vaginal bleeding; severe nausea; vomiting.

Store EstroGel Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep EstroGel Gel out of the reach of children and away from pets.

General information:

• If you have any questions about EstroGel Gel, please talk with your doctor, pharmacist, or other health care provider.
• EstroGel Gel 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 EstroGel Gel. 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.