Estradiol Vaginal Tablets

What is this medication?

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 medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Vagifem

What should I tell my care team before I take this medication?

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

• Abnormal vaginal bleeding
• Blood vessel disease or blood clots
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Dementia
• Diabetes
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol
• High level of calcium in the blood
• Hysterectomy
• Kidney disease
• Liver disease
• Migraine headaches
• Protein C/S deficiency
• Stroke
• Systemic lupus erythematosus (SLE)
• Tobacco smoker
• An unusual or allergic reaction to estrogens, other hormones, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is only for use in the vagina. Do not take by mouth. Wash and dry your hands before and after use. Read package directions carefully. Unwrap the applicator package. Be sure to use a new applicator for each dose. Use at the same time each day. 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 your medication more often than directed. Do not stop using except on the advice of your care team.

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

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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.

What may interact with this medication?

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

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

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 have any reason to think you are pregnant; stop taking this medication at once and contact your care team.

Tobacco smoking increases the risk of getting a blood clot or having a stroke, especially if you are more than 35 years old. You are strongly advised not to smoke.

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, you may need to stop taking this medication beforehand. Consult your care team for advice prior to scheduling the surgery.

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.