Ursodiol (another brand of Ursodeoxycholic acid) 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. Ursodeoxycholic Acid is used to treat people with primary biliary cirrhosis (PBC; 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. Actigall capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. This medicine capsules are not for treating gallstones that are calcified. Actigall may also be used for purposes not listed in this medication guide.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. It is best to take ursodiol with meals, unless otherwise directed by your doctor.Take this medicine for the full time of treatment, even if you begin to feel better. If you stop taking this medicine too soon, the gallstones may not dissolve as fast or may not dissolve at all.It is thought that body weight and the kind of diet the patient follows may affect how fast the stones dissolve and whether new stones will form. However, check with your doctor before going on any diet.

It is important that your doctor check your progress at regular visits. Blood tests will have to be done every few months while you are taking this medicine to make sure that the gallstones are dissolving and your liver is working properly.

Check with your doctor immediately if severe abdominal or stomach pain, especially toward the upper right side, or severe nausea and vomiting occur. These symptoms may mean that you have other medical problems or that your gallstone condition needs your doctor's attention.Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.Also, 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.

Side effects of the medication include but are not limited to:

Upset stomach nausea, diarrhea, dizziness, back pain, hair loss, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: weakness, swelling of the ankles/feet, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• severe stomach area pain, especially toward your right side

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

• constipation
• gas
• indigestion
• nausea

What should I tell my health care provider before I take this medicine?

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

• blocked bile duct or fistula
• pancreatitis
• an unusual or allergic reaction to ursodiol, bile acids, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding