EstroGel Transdermal

This medication is a female hormone (estrogen). It is absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Certain brands may also help to reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

How to use Estrogel Gel In Metered-Dose Pump

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. Learn how to use the pump and how to apply the gel correctly. If you have any questions, ask your doctor or pharmacist.

Follow the instructions for priming the pump if you are using it for the first time.

Use exactly as directed by your doctor. Apply the medication to clean, dry skin on the upper arm/shoulder area, usually once daily. Some brands may be applied on the arm from the wrist to the shoulder. Follow the directions for your specific brand. Avoid applying this medication to broken, irritated skin. Do not apply this medication to the breast, face, or in or around the vagina. Do not let others apply this medication to your body.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this medication more often than prescribed.

Replace the cap on the pump after each use. After applying this medication, wash your hands thoroughly with soap and water to reduce the risk of accidentally spreading it from your hands to other people. Wait about 5 minutes for the application site to dry completely before dressing. Cover the application site with clothing (such as a long-sleeve shirt) to prevent others from touching the application area and being exposed to the drug. Wait at least 1 to 2 hours (depending on your brand) before allowing others to touch the skin where the medication was applied. If someone accidentally touches the gel (or the application area within 1 to 2 hours), have them wash the area of contact on their body with soap and water as soon as possible.

To get the best effect, wait at least 2 hours before showering/swimming to allow the drug to be absorbed through the skin.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Avoid getting this medication in the eyes. If this medication gets in the eyes, rinse them right away with warm water. Tell your doctor if you get any eye irritation.

This medication is flammable until dry. Let the gel dry before smoking or going near an open flame.

Learn how many doses the gel pump delivers. Keep track of the number of doses used and discard the pump after all the doses are used, even though there may be some gel left in the pump.

Tell your doctor if your condition does not improve or if it worsens.

See also Warning section.

Nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, mental/mood disorders (such as dementia, depression), a certain blood disorder (porphyria).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop this medication for a time or take special precautions.

This drug may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Wear protective clothing when outdoors. Ask your doctor or pharmacist about using sunscreen with this medication. Sunscreen may affect the absorption of this medication if applied on the area of the skin where the medication was applied.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This product is not meant for children. Children may be accidentally exposed to this medication by touching someone on the area where the medication was applied. If this occurs, the child may have unwanted side effects. Children should avoid contact with any unclothed area where the medication has been applied. Tell the doctor right away if you notice unexpected signs of puberty in a child such as an increase in breast or nipple size. To decrease this risk, carefully follow all directions for the proper use of this drug.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

Estrogel is a clear, colorless gel medicine that contains an estrogen hormone called estradiol. Estrogens are female sex hormones made by a woman's ovaries that regulate many processes in the body.

Estrogel is a prescription medicine used to reduce certain symptoms of menopause such as moderate to severe hot flashes, and vaginal symptoms such as dryness, burning, and irritation.

Estrogel may also be used for purposes not listed in this medication guide.

You should not use Estrogel if you have any of the following conditions: a history of heart attack, stroke, or blood clot, a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, history of an allergic reaction to estradiol topical, or a hormone-related cancer such as breast or uterine cancer.

Do not use if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using Estrogel.

Children should avoid coming into contact with skin areas where you have applied Estrogel. Topical estradiol is absorbed through the skin and can cause side effects in a child who comes into contact with this medicine or with skin where Estrogel was applied.

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use of Estrogel may also increase your risk of breast cancer or blood clot.

Use Estrogel exactly as prescribed by your doctor, Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Apply Estrogel only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated. Never apply this medicine to the breasts.

To use EstroGel:

• Before using the pump for the first time, it must be primed. Remove the large pump cover, and fully depress the pump twice for the 93-gram pump or three times for the 50-gram pump and the 25-gram pump. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash in a manner that avoids accidental exposure or ingestion by household members or pets. After priming, the pump is ready to use, and one complete pump depression will dispense the same amount of Estrogel each time.

• Apply Estrogel at the same time each day. You should apply your daily dose of gel to clean, dry, unbroken skin. If you take a bath or shower or use a sauna, apply your Estrogel dose after your bath, shower, or sauna. If you go swimming, try to leave as much time as possible between applying your Estrogel dose and going swimming.

• Be sure your skin is completely dry before applying Estrogel.

• To apply the dose, collect the Estrogel into the palm of your hand by pressing the pump firmly and fully with one fluid motion without hesitation.

• Apply the gel to one arm using your hand. Spread the Estrogel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder. Never apply Estrogel directly to the breast.

• Always place the small protective cap back on the tip of the pump and the large pump cover over the top of the pump after each use.

• Wash your hands with soap and water after applying the Estrogel to reduce the chance that the medicine will spread from your hands to other people.

• It is not necessary to massage or rub in Estrogel. Simply allow the gel to dry for up to 5 minutes before dressing.

• Estrogel is flammable. Avoid smoking or being near an open flame until the medicine has completely dried on your skin.

Wash your hands with soap and water after applying Estrogel. Avoid allowing other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

Children should avoid coming into contact with skin areas where you have applied Estrogel. Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estradiol.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.

Store Estrogel at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

Other drugs may interact with estradiol topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.