This medication is used by women after menopause to treat painful sexual intercourse. Painful intercourse can be a symptom of changes in and around your vagina, due to menopause. Prasterone belongs to a class of drugs known as steroids. It is not well understood how it works to lessen painful intercourse, but prasterone is changed in the body to certain hormones (androgens and estrogens).

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using prasterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for vaginal use only. Empty your bladder and wash your hands before handling the vaginal insert and applicator. Unwrap one vaginal insert and follow the instructions to use the applicator to insert this medication into the vagina as directed by your doctor, usually once daily at bedtime.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Vaginal discharge may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

You may have an abnormal Pap smear test result after using this medication. Your doctor will monitor your results and tell you if more tests are needed.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using prasterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breast cancer
• vaginal bleeding

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not usually used by women of childbearing age. Tell your doctor if you are planning pregnancy, become pregnant, or think you may be pregnant.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as Pap smear) may be done while you are using this medication. Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator or at room temperature away from light. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.