EstroGel Pump

EstroGel Pump (for the skin) is used by menopausal adult women to treat specific symptoms of menopause like hot flashes, and vaginal dryness, burning, and irritation.

EstroGel Pump may also be used for other reasons not mentioned in this medication guide.

You should not use this medicine if you have or have ever had: vaginal bleeding that has not been checked by your doctor, liver disease, a bleeding or blood clotting disorder, a heart attack, a stroke, a blood clot, or cancer of the breast or uterus.

EstroGel Pump may increase your risk of developing uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, dementia, stroke, heart attack, or breast cancer. Estradiol should not be used to prevent heart disease, stroke, or dementia.

EstroGel Pump is absorbed through the skin and can cause side effects in a child who comes into contact with the skin where you have applied the medicine.

You should not use estradiol if you are allergic to it or any of its ingredients, or if you have or have ever had:

• unusual vaginal bleeding that has not been checked by a doctor;
• a heart attack, stroke, or blood clot;
• a bleeding or blood clotting disorder;
• hormone-related cancer such as breast or uterine cancer; or
• liver disease.

Estradiol should not be used to prevent heart disease, stroke, or dementia. Using EstroGel Pump may increase your risk of blood clots, dementia, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Tell your doctor if you have or have ever had:

• heart disease;
• gallbladder disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• bone cancer;
• a family history of breast cancer;
• systemic lupus erythematosus (SLE);
• diabetes;
• endometriosis or uterine fibroid tumors;
• hereditary angioedema;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• high triglycerides;
• a thyroid disorder;
• hypoparathyroidism;
• abnormal levels of calcium in your blood;
• endometrial hyperplasia (overgrowth of cells lining the uterus);
• if you have had your uterus removed (hysterectomy);
• liver problems such as a liver tumor or jaundice (caused by pregnancy or hormones); or
• kidney disease.

Long-term use of estradiol may increase your risk of cancer of the breast or uterus. Talk with your doctor about this risk.

Do not use EstroGel Pump if you are pregnant. Tell your doctor right away if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

EstroGel Pump can increase your risk of blood clots, stroke, or heart attack. Get emergency medical help if you have: chest pain, pain, swelling or warmth in your leg, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath or trouble breathing.

EstroGel Pump may cause serious side effects. Call your doctor at once if you have:

• change in the pattern or severity of migraine headaches;
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding;
• a lump in your breast;
• changes in vision;
• abnormal lab results such as increased fat in your blood (triglycerides) or thyroid hormone levels;
• signs of gallbladder, liver, or pancreas problems--chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, loss of appetite, upper stomach pain (that may spread to your back), vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
• increased blood pressure-- severe headache, pounding in your neck or ears; or
• low or high blood calcium levels--constipation, increased thirst or urination, muscle spasms, weight loss, tingly feeling (around your mouth, or in your fingers and toes).

Topical estradiol is absorbed through the skin of a child who comes into contact with EstroGel Pump. Call your doctor if a child in close contact with you develops swollen nipples or enlarged breasts.

Common side effects of EstroGel Pump may include:

• nausea, vomiting, stomach cramps;
• bloating, swelling, weight gain;
• breast pain or tenderness;
• headache;
• vaginal itching or discharge, irregular vaginal bleeding or spotting;
• hair loss; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

EstroGel Pump is usually applied once per day. Follow your doctor's instructions.

Use the medicine at the same time each day.

Read and carefully follow any Instructions for Use provided on how to apply this medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands with soap and water after applying the medicine. Do not allow other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine. Do not allow a child to come into contact with the skin where you have applied EstroGel Pump. If you cover with clothing, allow the medicine to dry well.

If you need surgery, or will be on bed rest, tell your healthcare provider ahead of time that you are using EstroGel Pump. You may need to stop using the medicine for a short time.

Estradiol may increase your risk of developing a condition that can lead to uterine cancer. To lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.

You may need frequent medical tests and your doctor will need to check your progress on a regular basis to determine how long you should use EstroGel Pump. You may need a pelvic exam, breast exam, and mammogram every year while using this medicine. Follow your doctor's instructions.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using EstroGel Pump.

Store at room temperature away from moisture and heat.

EstroGel Pump may be flammable. Do not use near high heat or open flame. Do not smoke until the medicine has completely dried on your skin.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting EstroGel Pump in your eyes. If contact occurs, rinse with water.

Do not apply EstroGel Pump to your breast area.

Ask your doctor when to use sunscreen or other skin products on skin treated with EstroGel Pump.

Avoid smoking. It can greatly increase your risk of blood clots, dementia, stroke, or heart attack while using this medicine.

Grapefruit may interact with EstroGel Pump and cause side effects. Avoid consuming grapefruit products.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Many drugs can affect EstroGel Pump. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you are using.