Materials for patient education:
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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.
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