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 listed in the FDA-Approved Patient Labeling.
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:
Cancer of the lining of the uterus (womb)
Cancer of the ovary
High blood pressure
High blood sugar
Enlargement of benign tumors of the uterus ("fibroids")
Call your healthare 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:
Irregular vaginal bleeding or spotting
Stomach or abdominal cramps, bloating
Nausea and vomiting
Vaginal yeast infection
Important things to remeber 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.
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.
Never apply ELESTRIN to the breast. Never apply ELESTRIN in or around the vagina.
Do not allow others to apply 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.
These are not all the possible side effects of ELESTRIN. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also call Mylan at 1-877-4-INFO-RX.
ELESTRIN (estradiol gel) is used after menopause to reduce moderate to severe hot flashes.