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Uses

ELESTRIN (estradiol gel) is used after menopause to reduce moderate to severe hot flashes.

Important Safety Information
What is the most important information I should know about ELESTRIN (an estrogen hormone)?
  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb) Report any unusual vaginal bleeding right away while you are using ELESTRIN. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with ELESTRIN
Do not start using ELESTRIN if you:
  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers
    Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use ELESTRIN.
  • Had a stroke or heart attack
  • Currently have or have had blood clots
  • Currently have or have had liver problems
  • Have been diagnosed with a bleeding disorder
  • Are allergic to ELESTRIN or any of its ingredients
    (Elestrin contains the Active ingredient, estradiol, an estrogen hormone. The Inactive ingredients in Elestrin are purified water, ethanol, propylene glycol, diethylene glycol monoethyl ether, carbomer 940, triethanolamine, and edetate sodium)
  • Think you may be pregnant
Tell your healthcare provider:
  • If you have any unusual vaginal bleeding
    Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • About all of your medical problems
    Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • About all the medicines you take
    This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how ELESTRIN works. ELESTRIN may also affect how your other medicines work.
  • If you are going to have surgery or will be on bed rest
    You may need to stop using ELESTRIN.
  • If you are breastfeeding
    the hormone in elestrin can pass into your breast milk.
What are the possible side effects of ELESTRIN?
Side effects are grouped by how serious they are and how often they happen when you are treated. Serious, but less common side effects include:
  • Heart attack
  • Stroke
  • Blood clots
  • Dementia
  • Breast cancer
  • Cancer of the lining of the uterus (womb)
  • Cancer of the ovary
  • High blood pressure
  • High blood sugar
  • Gallbladder disease
  • Liver problems
  • Enlargement of benign tumors of the uterus (“fibroids”)
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
  • New breast lumps
  • Unusual vaginal bleeding
  • Changes in vision or speech
  • Sudden new severe headaches
  • Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
Less serious, but common side effects include:
  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach or abdominal cramps, bloating
  • Nausea and vomiting
  • Hair loss
  • Fluid retention
  • Vaginal yeast infection

These are not all the possible side effects of ELESTRIN. For more information, ask your healthcare provider or pharmacist for advice about side effects.

Important things to remember when using ELESTRIN

Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people. Allow the gel to dry for five minutes or more before dressing. Try to keep the area dry for as long as possible. Do not allow others to come in contact with the area of skin where you applied the gel for at least two hours after you apply ELESTRIN. Do not apply sunscreen to the area where the gel was applied for at least 25 minutes or for 7 or more consecutive days.Never apply ELESTRIN to the breast. Never apply ELESTRIN in or around the vagina. Do not allow others to apply the gel for you. Avoid fire, flame or smoking until the gel has dried. ELESTRIN contains alcohol. Alcohol based gels are flammable. It is important that you read and follow the detailed "Patient Instructions for Use" on how to use the ELESTRIN pump and apply the dose.
Keep ELESTRIN out of the reach of children.

You may report side effects to Meda Pharmaceuticals at 1-800-890-3098 or to FDA at 1-800-FDA-1088.

©2015 Meda Pharmaceuticals Inc. All rights reserved. US/ELE/1215/0006(1)