Pronunciation:

hye-drox-ee-ETH-il SEL-ue-lose, GLIS-er-in, Water, Purified, Water, Purified

Uses of This Medicine:

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 that is used for sonohysterosalpingography. Sonohysterosalpingography is a kind of ultrasound exam wherein a fluid is put into the uterus through the cervix using a thin plastic tube. Sound waves are used to 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.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care 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.

Children—

Appropriate studies on the relationship of age to the effects of ExEm® foam have not been performed in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of ExEm® foam in geriatric patients.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Arsenic Trioxide

Receiving this diagnostic test with any of the following medicines may cause an increased 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 use one or both of the medicines.

• Licorice

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Receiving this medicine while you are pregnant can harm your unborn baby. Your doctor will give you a pregnancy test before you start using this medicine to make sure you are not pregnant. If you think you have become pregnant, tell your doctor right away.

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 occur in some patients. If you notice any other effects, check with your healthcare professional.

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