Uses of Urso 250:

• It is used to treat or prevent gallstones.
• It is used to treat a type of liver disease caused by bile duct problems in the liver (biliary cirrhosis).

What do I need to tell my doctor BEFORE I take Urso 250?

• If you have an allergy to ursodiol or any other part of Urso 250 (ursodiol).
• If you are allergic to Urso 250 (ursodiol); any part of Urso 250 (ursodiol); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a biliary tract block.
• If you have a certain bile duct problem (cholangitis).
• If you have any of these health problems: Abnormal opening in the biliary and GI (gastrointestinal) tracts, pancreatitis, or swelling of the gallbladder (cholecystitis).

This is not a list of all drugs or health problems that interact with Urso 250 (ursodiol).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Urso 250 (ursodiol) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Urso 250?

• Tell all of your health care providers that you take Urso 250 (ursodiol). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Urso 250) best taken?

Use Urso 250 (ursodiol) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• Some other drugs may need to be taken at some other time than Urso 250 (ursodiol). If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Urso 250 (ursodiol).

Tablets:

• Take with food.
• Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.
• If you break the tablet in half, use the other half of the tablet for the next dose, as told by the doctor. Throw away half-tablets not used within 28 days.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.

What are some other side effects of Urso 250?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Dizziness.
• Back pain.
• Diarrhea or constipation.
• Upset stomach or throwing up.
• Stomach pain or heartburn.
• Muscle or joint pain.
• Signs of a common cold.
• Hair loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Urso 250?

All products:

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Tablets:

• If you break the tablet in half, store the half-tablets apart from the whole tablets.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Urso 250 (ursodiol), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.