Product Information

Ursodiol tablet

What are ursodiol tablets?

URSODIOL is a bile acid. The drug helps dissolve gallstones in those who cannot have gallbladder surgery or who do not need the surgery. Ursodiol may be used with a procedural device that fragments the gallstone into smaller pieces; the procedure, called lithotripsy, allows the drug to dissolve the stones more quickly. Ursodiol is also useful for certain liver diseases of adults, children and infants; the drug reduces itching and other symptoms.

What should my health care professional know before I take ursodiol?

They need to know if you have any of these conditions:

• pancreatitis (an inflammation of the pancreas)
• an unusual or allergic reaction to ursodiol, bile acids, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take ursodiol capsules or tablets by mouth. Follow the directions on the prescription label. Take the capsules with food or milk to improve absorption and limit stomach or intestinal side effects. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. Usually, a pharmacist must prepare this medicine into a suspension for administration to children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with ursodiol?

• activated charcoal
• antacids
• cholestyramine
• clofibrate, fenofibrate, or gemfibrozil
• ciprofloxacin
• colesevelam
• colestipol
• dextrothyroxine
• female hormones, including estrogens or birth control pills

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking ursodiol?

Visit your prescriber or health care professional for regular checks on your progress. It may take months of therapy to get the right response. Your prescriber or health care professional will schedule tests to see if your gallstones are dissolving or if your liver problem is improving. Report continued or worsened nausea, vomiting, or abdominal pain to your prescriber.

Continue to take your medicine even if you feel better, unless directed otherwise by your prescriber or health care professional. Do not stop taking except on your prescriber's advice.

Antacids may interfere with the absorption of ursodiol. Take ursodiol at least 1 hour before or 2 hours after an antacid dose.

What side effects may I notice from taking ursodiol?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• any signs of an allergic reaction (rare): difficulty breathing, hives, skin rash or unusual itching
• severe stomach area pain, especially toward your right side

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• cough or sore throat
• diarrhea
• hair loss or thinning
• headache
• joint or muscle aches
• constipation
• gas
• indigestion
• nausea

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature below 30 degrees C (86 degrees F). Keep in a well-closed container. Throw away any unused medicine after the expiration date.