Urso Forte

Ursodiol comes as a capsule to take by mouth. It is usually taken two or three times a day to treat gallstones and two times a day to prevent gallstones in patients who are losing weight quickly. 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.

This drug must be taken for months to have an effect. 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.

• Actigall^®
• Urso^® 250
• Urso^® Forte

Urso Forte is part of the drug class:

• Bile acid preparations

Serious side effects have been reported with Urso Forte including the following:

• frequent urination or pain when you urinate
• cough with fever

Urso Forte can cause dizziness. Do not drive or operate heavy machinery until you know how Urso Forte affects you.

Do not take Urso Forte if you are allergic to Urso Forte or to any of its ingredients.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Urso Forte crosses into human milk. Because many medications can cross into human milk, caution should be exercised when Urso Forte is administered to a nursing mother.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Ursodiol is used to dissolve gallstones in patients who do not need to have their gallbladders removed or in those in whom surgery should be avoided because of other medical problems. However, ursodiol works only in those patients whose gallstones are made of cholesterol and works best when these stones are small and of the “floating” type. It is also used to help prevent gallstones in patients who are on rapid weight-loss programs.

Ursodiol is also used to treat primary biliary cirrhosis (PBC). PBC is an autoimmune disorder that causes a patient's liver to have problems and not work properly.

This medicine is available only with your doctor's prescription.

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 nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• dizziness
• fast heartbeat
• frequent urge to urinate
• indigestion
• lower back or side pain
• severe nausea
• skin rash or itching over the entire body
• stomach pain
• vomiting
• weakness

• Black, tarry stools
• chest pain
• chills or fever
• cough
• pinpoint red spots on the skin
• severe or continuing stomach pain
• sore throat or swollen glands
• sores, ulcers, or white spots on the lips or in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

• Clay-colored stools
• dark urine
• difficulty with swallowing
• headache
• hives or welts
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea
• redness of the skin
• slow or irregular breathing
• tightness in the chest
• unpleasant breath odor
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• body aches or pain
• congestion
• constipation
• general feeling of discomfort or illness
• heartburn
• loss of voice
• muscle aches
• muscle or bone pain
• pain, swelling, or redness in the joints
• runny nose
• sweating
• trouble sleeping

• Diarrhea

• Worsening psoriasis

• Acid or sour stomach
• belching bloating or swelling of face, arms, hands, lower legs, or feet
• difficulty with moving
• rapid weight gain
• stomach discomfort or upset
• tingling of the hands or feet
• unusual weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.