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Recommended dosage of colchicine depends on whether patient is receiving or has recently within 14 days received a moderate or potent cyp3a4 inhibitor or an inhibitor of the p-glycoprotein transport system see table 3 .

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Advise patients that muscle pain or weaknesstingling or numbness in fingers or toes may occur with colchicine capsules alone or when it is used with certain other drugsPatients developing any of these signs or symptoms must discontinue colchicine capsules and seek medical evaluation immediately.

These are not all of the possible side effects of colchicine capsulesFor more information ask your healthcare provider or pharmacist.

Limitations of useThe safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.

Some drugs such as HMG-CoA reductase inhibitors and fibrates may increase the risk of myopathy when combined with colchicine capsulesComplaints of muscle pain or weakness could be an indication to check serum creatinine kinase levels for signs of myopathy.

Patients with liver or renal impairment should be carefully monitored for adverse effects of colchicinesee section 5.2

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pharmacokinetic studies evaluating changes in systemic levels of colchicine when co-administered with cyp3a4 inhibitors in healthy volunteers have been conducted with colchicine capsules.

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