Please read this important safety information carefully. This page contains essential information about Reltone (ursodiol) that you should discuss with your healthcare provider.
WHAT IS RELTONE?
Reltone (ursodiol capsules) is an FDA-approved prescription medicine for people with certain types of gallstones.
1. Reltone may be used to dissolve gallstones in people who cannot or choose not to have surgery to remove the gallbladder (elective cholecystectomy). They may not be able to have surgery because of higher risk due to disease, age, or reaction to anesthesia. Reltone may be used to dissolve gallstones that are:
2. Reltone is also used to prevent gallstones from forming in patients with body mass index (BMI) ≥ 30 experiencing rapid weight loss from either surgery or dieting.
IMPORTANT SAFETY INFORMATION
Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, the gallstone is not completely dissolved. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It is not known if Reltone is safe to use for longer than 24 months.
Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.
Reltone will not dissolve gallstones that are
Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).
Do not use Reltone if you have an allergy to bile acids.
When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.
Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.
Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, the gallstone is not completely dissolved. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It is not known if Reltone is safe to use for longer than 24 months.
Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.
Reltone will not dissolve gallstones that are:
Patients Requiring Gallbladder Surgery
Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliarygastrointestinal fistula).
Allergy to Bile Acids
Do not use Reltone if you have an allergy to bile acids.
When Used for Dissolving Gallstones
When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis.
When Used for Preventing Gallstones
When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.
Report Side Effects
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
