Femtrace

Femtrace is a prescription medication used after menopause to reduce moderate to severe hot flashes. Femtrace contains the hormone, estradiol, and belongs to a group of drugs called estrogens. Femtrace works as a hormone replacement to relieve issues caused by hormonal changes. 

Femtrace comes in tablet form and is usually taken once daily, with or without food. 

Common side effects of Femtrace include headache, breast pain, and irregular vaginal bleeding or spotting.

Femtrace is a prescription medication used after menopause to reduce moderate to severe hot flashes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Warner Chilcott (US), LLC

Serious side effects have been reported with Femtrace. See the “Femtrace Precautions” section.

Common side effects of Femtrace include the following:

• headache
• breast pain
• irregular vaginal bleeding or spotting
• stomach or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection

This is not a complete list of Femtrace side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Drugs that may interact with Femtrace include:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

This is not a complete list of Femtrace drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Femtrace including the following:

• 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
• changes in your thyroid hormone levels
• 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. 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. 
• 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

What can I do to lower my chances of a serious side effect with Femtrace?

• Talk with your healthcare provider regularly about whether you should continue taking Femtrace.
• If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
• The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
• See your healthcare provider right away if you get vaginal bleeding while taking Femtrace.
• Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else.
• If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or use tobacco, you may have a higher chance of getting heart disease.
• Ask your healthcare provider for ways of lowering your chances of getting heart disease.

Do not take Femtrace if you:

• are allergic to Femtrace or to any of its ingredients
• 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 and 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
• currently have or have had blood clots
• currently have or have had liver problems
• have been diagnosed with a bleeding disorder
• think you may be pregnant

Grapefruit and grapefruit juice theoretically may interact with Femtrace and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Femtrace, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Femtrace or to any of its ingredients
• have any unusual vaginal bleeding
• have any other medical conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood
• are going to have surgery or will be on bed rest
• are breastfeeding
• are pregnant or plan to become pregnant

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Femtrace is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take Femtrace if the test is positive. Tell your doctor right away if you become pregnant. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Estrogens, such as femtrace, have been detected in human breast milk. Femtrace can decrease the quality or quantity of breast milk. A choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Femtrace exactly as your healthcare provider tells you to take it.

• Take 1 Femtrace tablet at the same time each day.
• You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with Femtrace.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Femtrace is 0.45 mg a day taken by mouth once daily.

If you take too much Femtrace, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Femtrace at room temperature, 68°F to 77°F (20°C to 25°C).

Keep this and all medicines out of the reach of children.

WARNING: ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking Femtrace. 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 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 65 years of age 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 65 years of age or older.

You and your healthcare provider should talk regularly about whether you still need treatment with Femtrace.