Urso capsules are used to dissolve small gallstones that cannot be removed with surgery, or to prevent gallstones that may occur during rapid weight loss. This medicine will not dissolve calcified gallstones.

Urso tablets are used to treat primary biliary cirrhosis, an autoimmune disorder that causes progressive destruction of the bile ducts in your liver.

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the Urso tablet with food.

You may need to break a tablet in half to get your correct dose.

Swallow each tablet piece whole with a glass of water. A broken tablet may have a bitter taste.

After breaking a tablet, keep it separate from the whole tablets and use it within 28 days after breaking.

Use Urso regularly for the best results.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may need medical tests, including gallbladder ultrasound exams and blood tests to check your liver function. You may also need liver function tests every 6 months after you stop using Urso.

Call your doctor if your symptoms do not improve, or if they get worse.

To treat gallstones, you may have to take Urso for several months. Some gallstones may not completely dissolve, and you may develop new gallstones within 5 years after treatment. Ask your doctor about your risk.

Store tightly closed at room temperature, away from moisture and heat.

You should not use Urso if you are allergic to it, or if you have an obstruction in your liver or gallbladder.

Tell your doctor if:

• you have been coughing up blood; or

• you have gained weight rapidly, especially in your face and midsection.

Tell your doctor if you are pregnant or breastfeeding.

Not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Ask your doctor before taking an antacid, and take only the type your doctor recommends.

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

Urso may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate;

• stomach pain or discomfort, constipation, vomiting;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of a new infection--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, trouble swallowing.

Common side effects of Urso may include:

• upset stomach, nausea, vomiting;

• diarrhea, constipation;

• cough, sore throat;

• painful urination;

• hair loss; or

• back pain.

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 may be harder for your body to absorb Urso if you take certain cholesterol-lowering medicines, such as:

• antacids that contain aluminum;

• cholestyramine; or

• colestipol.

Tell your doctor about all your other medicines, especially birth control pills, clofibrate, and other estrogens.

Other drugs may affect Urso, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.