Hydroxyethyl cellulose, glycerin, and purified water (Intrauterine)

ExEm® foam is used to check or assess the fallopian tube of women with known or suspected infertility (unable to have children).

ExEm® foam is an ultrasound contrast dye used for sonohysterosalpingography. Sonohysterosalpingography is a type of ultrasound exam where a fluid is inserted into the uterus through the cervix using a thin plastic tube. Sound waves create images or pictures of the uterus and fallopian tube.

This medicine is to be given only by or under the direct supervision of your doctor.

Your doctor will closely monitor your progress while you are using this medicine. This will help your doctor determine if the medicine is effective and if you should continue to use it.

Using this medicine during pregnancy can harm your unborn baby. Your doctor will perform a pregnancy test before you begin using this medicine to ensure you are not pregnant. If you think you might be pregnant, inform your doctor immediately.

This medicine may raise your risk of gynecological infections after using it. Inform your doctor right away if you experience dull or aching abdominal or stomach pain, foul-smelling vaginal discharge, painful urination, or unusual vaginal bleeding.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits. This is a decision you and your doctor will make together. Also, other factors may affect test results. For this test, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on how age affects the effects of ExEm® foam have not been done in children. Safety and effectiveness have not been established.

Geriatric

No information is available on how age affects the effects of ExEm® foam in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to change the dose, or other precautions may be needed. When you are receiving this diagnostic test, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Arsenic Trioxide

Receiving this diagnostic test with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this diagnostic test. Make sure to inform your doctor if you have any other medical problems, especially:

• Lower genital tract infection, known or suspected
• Patients who have had a gynecological procedure within the last 30 days
• Uterine cancer or tumors
• Unusual vaginal bleeding—Should not be used in patients with these conditions.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Abdominal or stomach pain
• fainting
• light vaginal bleeding after the procedure
• nausea
• pelvic pain
• slow heartbeat
• unusual tiredness or weakness (severe)

Incidence not known

• Dull or aching abdominal or stomach pain
• foul-smelling vaginal discharge
• increased urge to urinate
• painful urination
• shivering fever
• unusual tiredness or weakness
• unusual vaginal bleeding

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

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

A doctor or other trained health professional will give you this medicine. This medicine is given through a tube into the uterus through the cervix before an ultrasound.