Read this PATIENT INFORMATION before you start taking estradiol and read what you get each time you refill estradiol tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
WHAT ARE ESTRADIOL TABLETS?
Estradiol tablets are medicine that contains estrogen hormones.
Estrogens are hormones made by a woman's ovaries. Between ages 45 and 55, the ovaries normally stop making estrogens. This leads to a drop in body estrogen levels which causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause."
When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with estradiol.
Weight-bearing exercise, like walking or running, and taking calcium with vitamin D supplements may also lower your chances for getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your healthcare provider before starting them.
You and your healthcare provider should talk regularly about whether you still need treatment with estradiol to control these problems. If you use estradiol only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use estradiol only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you should continue with estradiol.
Unusual vaginal bleeding can be a warning sign of cancer of the uterus, especially if it happens after menopause. Your doctor must find out the cause of the bleeding so that he or she can recommend the proper treatment. Taking estrogens without visiting your doctor can cause you serious harm if your vaginal bleeding is caused by cancer of the uterus.
Estrogens may increase the risk of certain types of cancer, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take estradiol.
(For certain patients with breast or prostate cancer, estrogens may help.)
See the end of this leaflet for a list of ingredients in estradiol tablets.
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how estradiol tablets work. Estradiol tablets may also affect how your other medicines work.
These are some of the warning signs of the serious side effects:
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.
These are not all the possible side effects of estradiol tablets. For more information, ask your healthcare provider or pharmacist.
WHAT CAN I DO TO LOWER MY CHANCES OF A SERIOUS SIDE EFFECT WITH ESTRADIOL?
If you use estrogens, you can reduce your risks by doing these things:
If any of these warning signals (or any other unusual symptoms) happen while you are using estrogens, call your doctor immediately:
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
GENERAL INFORMATION ABOUT SAFE AND EFFECTIVE USE OF ESTRADIOL TABLETS
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
Do not take estradiol tablets for conditions for which they were not prescribed. Do not give estradiol tablets to other people, even if they have the same symptoms you have. They may harm them.
KEEP ESTRADIOL TABLETS OUT OF THE REACH OF CHILDREN
This leaflet provides a summary of the most important information about estradiol tablets. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about estradiol tablets that is written for health professionals. For more information about estradiol call Epic Pharma, LLC at 1-888-374-2791.
WHAT ARE THE INGREDIENTS IN ESTRADIOL TABLETS?
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of estradiol, USP.
In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.