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INDICATION AND IMPORTANT SAFETY INFORMATION
GLOPERBA® (colchicine) 0.6 mg oral solution is indicated for the prevention (prophylaxis) of gout flares in adults. The safety and effectiveness of GLOPERBA for the treatment of gout flares during prophylaxis has not been studied.
Important Safety Information for GLOPERBA® (colchicine)
GLOPERBA can cause serious side effects or death if levels of GLOPERBA are too high in your body. Taking GLOPERBA with certain medicines can cause GLOPERBA levels to be too high, even if you have taken the recommended dose, especially if you have kidney or liver problems. Patients with both kidney and liver problems should not take GLOPERBA.
Fatal overdoses have been reported with colchicine in adults and children. Keep GLOPERBA out of reach of children.
Blood problems including myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported in patients taking GLOPERBA.
Muscle weakness has happened in some people taking GLOPERBA, especially in combination with other drugs known to cause this effect.
Patients with liver or kidney problems and elderly patients are at increased risk of serious side effects when using GLOPERBA.
The most common side effects in people who take GLOPERBA are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Use of GLOPERBA oral solution
GLOPERBA 0.6 mg oral solution is indicated for the prevention (prophylaxis) of gout flares in adults. The safety and effectiveness of GLOPERBA for the treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not a pain medication and should not be used to treat pain from other causes.
You are encouraged to report negative side effects of prescription drugs to the FDA.
To report suspected adverse reactions, visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see accompanying full Prescribing Information, including Medication Guide.