Three major female sex hormones exist in your body: estrogen, progesterone, and testosterone. Progesterone works with estrogen to maintain reproductive organs, prepare for conception and pregnancy, and regulate menstrual cycles. One of the many things estrogen does is to thicken and build the endometrium (the lining of the woman's uterus) each month. This is the body's natural way of getting ready for pregnancy. When pregnancy doesn't happen, both estrogen and progesterone suddenly drop at the end of each cycle, and the uterus sheds its lining.

Hormones do not only change during puberty; they change every month as part of your menstrual cycle.

Women go through many hormonal changes throughout their lives.

During their childbearing years, some women stop menstruating. There can be many reasons a woman's period stops before she begins menopause. When this happens for at least 6 months, it is called secondary amenorrhea.

After a woman's childbearing years, she enters a period of time when her menstrual cycle gradually shuts down. This is a time of major change in your hormones — menopause.

Menopause is a time when your body makes approximately one half the amount of progesterone it used to.

Without enough progesterone, your menstrual period becomes irregular or infrequent, and the lining of the uterus stays thick and full of blood. Then, if that lining stays thickened month after month, it can be unhealthy. This can increase the chances of developing hyperplasia, or an overgrowth of cells in the uterine lining, which can lead to endometrial cancer. To help increase hormone levels in your blood, your healthcare provider may prescribe hormone therapy.

• Hot flashes
• Night sweats
• Vaginal dryness

• Help shed your uterine lining
• Help prevent abnormal cells from growing in the estrogen-thickened lining of the uterus, or endometrial hyperplasia
• Are absorbed differently in your body and thus may have different physiological effects
• May lead to side effects such as spotting, menstrual cramps, bloating, drowsiness, dizziness, breast tenderness, headache, and mood swings
• Do not need to be taken by women who have had a hysterectomy

Some hormone therapies are compounded in pharmacies. Traditional compounding involves combining, mixing, or altering ingredients by a pharmacist, according to a prescription from a licensed healthcare professional, to produce a drug that meets an individual's special medical needs. Compounded products may use ingredients like estradiol and progesterone, and the products created this way are not FDA approved.

The FDA considers traditional compounding to be a valuable service when used appropriately, such as customizing a drug for someone who is allergic to a dye or preservative in an FDA-approved medicine.

The FDA encourages consumers to become informed about compounded products. Please talk to your healthcare professional to answer any questions.

Uses
PROMETRIUM^® (progesterone, USP) Capsules are used with estrogen in postmenopausal women with a uterus for the prevention of abnormal thickening of the lining of the uterus (endometrial hyperplasia).

PROMETRIUM^® Capsules are also used to treat the absence of menstrual periods in women who have previously had a menstrual period (secondary amenorrhea).

Important Safety Information

Estrogen with or without progestins should not be used to prevent heart disease, heart attacks, strokes or dementia.

Estrogen with or without progestins may increase your chance of having a heart attack, blood clot or stroke. It may also increase your risk for developing breast cancer. A study of women 65 years and older showed estrogen with or without progestins may increase your chance of developing dementia. You should talk to your doctor on a regular basis about whether or not you should continue treatment with PROMETRIUM^®.

PROMETRIUM^® CONTAINS PEANUT OIL AND SHOULD NOT BE USED IF YOU ARE ALLERGIC TO PEANUTS.

You should not take PROMETRIUM^® if you are allergic to any of the ingredients in the medication, have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, or think you may be pregnant.

If you experience chest pain or pain between the shoulder blades, shortness of breath or difficulty breathing, swelling or pain in the legs, severe headache, difficulty speaking or walking, breast pain or feel a lump in your breast, confusion and/or memory problems, you should contact your doctor immediately, as these could be signs of a serious problem.

Due to increased risk of breast cancer while using this medication, all women should do a self-exam of the breasts each month and have a yearly exam by their healthcare provider.

Notify your healthcare provider right away if you experience unusual vaginal bleeding, sudden loss of vision, double vision, or if migraine headaches occur.

PROMETRIUM^® may cause dizziness and/or drowsiness. You should use caution when driving or operating machinery. This medication should be taken at bedtime.

The most common side effects include dizziness, abdominal pain (cramping), headache, breast tenderness/pain, musculoskeletal pain, viral infection, depression, urinary problems, abdominal bloating and vaginal discharge.

For more information, talk with your healthcare professional.

Please click here for PROMETRIUM Patient Information.

Please click here for the PROMETRIUM full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.