Ursodiol

WHY is this medicine prescribed?

Ursodiol is used to dissolve gallstones in people who do not want surgery or cannot have surgery to remove gallstones. Ursodiol is also used to prevent the formation of gallstones in overweight people who are losing weight very quickly. Ursodiol is used to treat people with primary biliary cholangitis (PBC; formerly known as a primary biliary cirrhosis; an autoimmune liver disease). Ursodiol is in a class of medications called gallstone dissolution agents. It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile to prevent stone formation and by decreasing toxic levels of bile acids that accumulate in primary biliary cirrhosis.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ursodiol comes as a capsule and as a tablet to take by mouth. It is usually taken two or three times a day with or without food to treat gallstones and two times a day to prevent gallstones in people who are losing weight quickly. If you are taking the tablets to treat primary biliary cholangitis, they are usually taken 2 or 4 times a day with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ursodiol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you need to break the tablet for your specific dose, place the tablet on a flat surface with the scored section on the top. Hold the tablet with your thumbs close to the scored part and apply gentle pressure to snap the tablet into two parts. Swallow the half tablet with water; do not chew the half tablet. Because the tablet has a strong bitter taste, store the other tablet half in a separate container from the whole tablets. Use the stored half tablet within 28 days. If you have any questions, your doctor or pharmacist will tell you how to break the tablets and how you should take and store them.

This medication must be taken for months to have an effect. If you are taking ursodiol capsules to dissolve gall stones, you may need to take ursodiol for up to 2 years. Your gallstones may not completely dissolve, and even if your gallstones do dissolve you may have gallstones again within 5 years after successful treatment with ursodiol. Continue to take ursodiol even if you feel well. Do not stop taking ursodiol without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking ursodiol,

• tell your doctor and pharmacist if you are allergic to ursodiol, bile acids, or any other medications, or any of the ingredients in ursodiol tablets and capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with ursodiol: antacids that contain aluminum. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking ursodiol. Do not start any of these medications while taking ursodiol without discussing it with your healthcare provider.

• tell your doctor if you have bile duct blockage. Your doctor will probably tell you not to take ursodiol. Your doctor also will probably tell you not to take ursodiol if you have a type of gallstone that will not dissolve or if surgery is a better choice for your condition.

• tell your doctor if you have had gastrointestinal surgery. Also, tell your doctor if you have or have ever had variceal bleeding (bleeding in the esophagus or stomach), Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking ursodiol, call your doctor.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ursodiol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• headache
• cough, fever, sore throat, runny nose, or other signs of infection
• frequent urination or pain when you urinate
• muscle pain
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• indigestion
• stomach pain
• nausea
• vomiting
• diarrhea
• constipation
• hives; rash; itching; swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs; or difficulty breathing or swallowing

Ursodiol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order blood tests to check your liver function every few months while you take ursodiol. You will also have to have an ultrasound (a type of imaging to look at organs and structures inside the body) to see how your gallstones are responding to ursodiol.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.