Estring®(estradiol)

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using ESTRING. 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.Do not use estrogens with or without progestins 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 estrogens with or without progestins may increase your chances 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 ESTRING.

ESTRING is a soft, flexible vaginal ring that releases estradiol (an estrogen hormone) into the vagina for 90 days.ESTRING is used to treat moderate to severe vaginal changes (dryness, itching, burning) that occur after menopause due to low estrogen levels.

• have unusual vaginal bleeding that has not been evaluated by your healthcare provider• currently have or have had certain cancers, including breast cancer or cancer of the uterus• have or have had blood clots (in your legs, lungs, or eyes)• have or have had a stroke or heart attack• have liver problems• have a bleeding disorder• have had an allergic reaction to ESTRING or any of its ingredients• think you may be pregnant

• have any unusual vaginal bleeding• have asthma (wheezing)• have epilepsy (seizures)• have diabetes• have migraine headaches• have endometriosis• have lupus• have heart problems or kidney problems• have liver problems or thyroid problems• have high blood pressure• have high cholesterol or triglycerides• are going to have surgery or will be on bed rest• are breastfeedingTell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Compress the ring and insert it into the upper third of the vagina.• ESTRING should be left in place continuously for 90 days, then removed and replaced with a new ring if continued treatment is needed.• When properly positioned, you should not feel anything.• Relief of symptoms typically takes approximately 2-3 weeks.• If ESTRING slips down or comes out, rinse with lukewarm water and reinsert.• ESTRING does not need to be removed during sexual intercourse, but may be removed if desired. If removed, rinse with lukewarm water and reinsert.

ESTRING may cause serious side effects, including:• Toxic shock syndrome. Seek immediate medical help if you have sudden fever, muscle pain, dizziness, faintness, diarrhea, vomiting, or a sunburn-like rash.• Ring adherence to vaginal wall. Tell your healthcare provider if you have difficulty removing the ring.• Vaginal erosion or ulceration. Report any vaginal discomfort, bleeding, or unusual discharge.• Severe allergic reactions. Get medical help right away if you have swelling of the face, lips, or throat, or trouble breathing.ESTRING may increase your chances of getting:• Cancer of the uterus• Stroke• Blood clots• DementiaThe most common side effects of ESTRING include:• increased vaginal secretions• headache• breast pain• nausea• vaginal yeast infectionsThese are not all the possible side effects of ESTRING. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store ESTRING at room temperature between 59°F to 77°F (15°C to 25°C).• Keep ESTRING and all medicines out of the reach of children.

Active ingredient: estradiol (2 mg)Inactive ingredients: silicone polymers, barium sulfate, and silicone fluid