Prasterone (PRAS-ter-one)

Treats pain during sex that can be caused by vaginal changes during menopause. This medicine is a steroid.

Brand Name(s):

Intrarosa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Suppository

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Wash your hands with soap and water before and after using this medicine.
• This medicine is to be used only in the vagina. Use at bedtime unless your doctor tells you otherwise.
• This medicine comes with a disposable applicator. Place the vaginal insert in the applicator and then insert it into your vagina. Use each applicator only once, and then throw it away.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. You may also store the medicine in the refrigerator.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby.
• Tell your doctor if you are breastfeeding, or if you have or have had breast cancer.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

If you notice these less serious side effects, talk with your doctor:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• White or brownish vaginal discharge

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088