Estradiol Vaginal tablet

ESTRADIOL (es tra DYE ole) reduces the vaginal symptoms of menopause, such as vaginal irritation, dryness, and pain during sex. It is an estrogen hormone.

This medication is for use in the vagina only. Do not take by mouth. Take it as directed on the prescription label at the same time every day. Do not use more often than directed.

Wash your hands before and after use. Read package directions carefully. Unwrap the applicator package. Be sure to use a new applicator for each dose. If the tablet has fallen out of the applicator, but is still in the package, carefully place it back into the applicator. If the tablet has fallen out of the package, that applicator should be thrown out, and you should use a new applicator containing a new tablet. Lie on your back, part and bend your knees. Gently insert the applicator as far as comfortably possible into the vagina. Then, gently press the plunger until the plunger is fully depressed. This will release the tablet into the vagina. Gently remove the applicator. Throw away the applicator after use. Do not use it more often than directed. Keep using it unless your care team tells you to stop.

A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time. The sheet may change often.

Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual vaginal discharge, itching, or odor
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bloating
• Breast pain or tenderness
• Nausea
• Vaginal irritation at application site
• Vomiting

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

They need to know if you have any of these conditions:

• Abnormal vaginal bleeding
• Blood vessel disease or blood clots
• Cancer, such as breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Dementia
• Diabetes
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol
• High levels of calcium in your blood
• Hysterectomy
• Kidney disease
• Liver disease
• Lupus
• Migraine headaches
• Protein C or S deficiency
• Stroke
• Tobacco use
• An unusual or allergic reaction to estrogens, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

Do not take this medication with any of the following:

• Aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

This medication may also interact with the following:

• Antibiotics used to treat tuberculosis like rifabutin, rifampin and rifapentine
• Raloxifene or tamoxifen
• Warfarin

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam. You should also discuss the need for regular mammograms with your care team, and follow their guidelines.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

If you may be pregnant, stop taking this medication right away and contact your care team.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. This risk is higher if you are 35 years or older.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

If you are going to have elective surgery, tell your care team that you are taking this medication. You may need to stop taking this medication before the surgery.