Intrarosa is a manmade form of a hormone called dehydroepiandrosterone (DHEA). DHEA is normally produced by your adrenal glands. DHEA is inactive by itself, but in the body DHEA can be converted into active sex hormones including estrogen and testosterone.

Intrarosa vaginal inserts are a prescription medicine used in women to treat painful sexual intercourse that is related related to vaginal changes (vulvar and vaginal atrophy) caused by menopause.

Intrarosa may also be used for purposes not listed in this medication guide.

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use Intrarosa exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Intrarosa is a vaginal insert that you place in your vagina with an applicator that comes with vaginal inserts.

Use only the applicator supplied with this medicine to insert a Intrarosa insert.

• The usual dose of Intrarosa is one insert placed into the vagina every day at bedtime.

• Each applicator is for one time use only.

• Empty your bladder and wash your hands before handling the vaginal insert and applicator.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

1. Remove one applicator from the package. Pull back on the plunger until it stops to activate the applicator. The applicator must be activated before use. Place the applicator on a clean surface.

2. Slowly pull the plastic tabs on the Intrarosa vaginal insert away from each other while keeping the vaginal insert still between your fingers. Carefully remove the vaginal insert from the plastic wrap. If a vaginal insert falls on an unsanitary surface, replace it with a new one.

3. Place the flat end of the Intrarosa vaginal insert into the open end of the activated applicator. You are now ready to insert the vaginal insert into your vagina.

4. Hold the applicator between your thumb and middle finger. Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.

5. Select the position for insertion of the vaginal insert that is most comfortable for you, either a lying position or a standing position.

6. Gently slide the vaginal insert end of the applicator into your vagina as far as it will comfortably go. Do not use force.

7. Press the applicator plunger with your index (pointer) finger to release the vaginal insert. Remove the applicator and throw it away after use.

Store this medicine at room temperature away from moisture and heat.

You may also store the medicine in a refrigerator. Do not freeze.

You should not use Intrarosa if you are allergic to prasterone, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor.

To make sure Intrarosa is safe for you, tell your doctor if you have ever had breast cancer.

Although this medicine is for use only in postmenopausal women, Intrarosa should not be used by a women who is pregnant or breast-feeding.

This medicine is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra inserts to make up the missed dose.

An overdose of Intrarosa is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Intrarosa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common Intrarosa side effects may include:

• vaginal discharge; or

• changes in your Pap smear results.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on prasterone used in the vagina. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.