Uses of Estradiol Vaginal Insert:

• It is used to treat vaginal pain during sex caused by changes that happen with menopause.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Estradiol Vaginal Insert?

• If you have an allergy to estradiol or any other part of estradiol vaginal insert.
• If you are allergic to estradiol vaginal insert; any part of estradiol vaginal insert; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had any of these health problems: Bleeding disorder, blood clots, a higher risk of having a blood clot, breast cancer, liver problems or liver tumor, heart attack, stroke, or a tumor where estrogen makes it grow.
• If you have unexplained vaginal bleeding.
• If you are pregnant or may be pregnant. Do not take estradiol vaginal insert if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with estradiol vaginal insert.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take estradiol vaginal insert with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Estradiol Vaginal Insert?

• Tell all of your health care providers that you take estradiol vaginal insert. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• High triglyceride levels have happened with estradiol vaginal insert. Tell your doctor if you have ever had high triglyceride levels.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take estradiol vaginal insert.
• Do not smoke. Smoking raises the chance of heart disease. Talk with your doctor.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• High calcium levels have happened with drugs like this one in some people with cancer. Call your doctor right away if you have signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain.
• If you are 65 or older, use estradiol vaginal insert with care. You could have more side effects.

How is this medicine (Estradiol Vaginal Insert) best taken?

Use estradiol vaginal insert as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take estradiol vaginal insert by mouth. For vaginal use only. Keep out of your mouth, nose, and eyes (may burn).
• Use estradiol vaginal insert at the same time of day.
• Put into the vagina as you have been told by your doctor. Be sure you know how often to do this and what dose to use. If you have questions, talk with your doctor.
• Wash your hands before and after use.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of low thyroid levels like constipation; not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Pelvic pain or pressure.
• Vaginal irritation.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Depression or other mood changes.
• Memory problems or loss.
• Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
• This medicine may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Estradiol Vaginal Insert?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Hair loss.
• Tender breasts.
• Upset stomach or throwing up.
• Stomach pain or cramps.
• Bloating.
• Back pain.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Estradiol Vaginal Insert?

• Store in the original container at room temperature.
• Protect from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about estradiol vaginal insert, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.