IMPORTANT SAFETY INFORMATION

Femtrace^® is the first tablet to treat moderate-to severe hot flashes and night sweats of menopause with the hormone estradiol acetate. Once in your body, Femtrace changes to estradiol, the same hormone made naturally in your ovaries. And since Femtrace is available in three strengths, your healthcare provider can prescribe the lowest dose that's right for you.

What are the possible side effects of Femtrace?
Less common but serious side effects include: breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, ovarian cancer.

These are some of the warning signs of serious side effects: breast lumps, unusual vaginal bleeding, dizziness and faintness, changes in speech, severe headaches, chest pain, shortness of breath, pains in your legs, changes in vision, vomiting. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects of estrogens include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss

In clinical studies with Femtrace the following side effects were observed:

• Headache
• Vaginal bleeding
• Breast tenderness

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

Tell your healthcare provider:

If you are breastfeeding. The hormone in Femtrace can pass into your milk.

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), migraine, endometriosis, lupus, 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 Femtrace® works. Femtrace 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 taking estrogens.

Who should not take Femtrace?

Do not start taking Femtrace if you:
Have unusual vaginal bleeding, currently have or have had certain cancers, (estrogens may increase the chances 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 take Femtrace), had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, think you may be pregnant or are allergic to Femtrace or any of its ingredients.

For more information, refer to the PATIENT PRODUCT INFORMATION.