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Co-administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to colchicinewhich may lead to colchicine induced toxicity including fatalitiesIf treatment with a P-gp inhibitor or a moderate or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic functiona reduction in colchicine dosage or interruption of colchicine treatment is recommendedsee section 4.5

Colchicine has been reported to cause neuromuscular toxicitywhich may present as muscle pain or weaknesssee WARNINGS AND PRECAUTIONS

Physicians should ensure that patients are suitable candidates for treatment with colchicine capsules and remain alert for signs and symptoms of toxic reactions associated with increased colchicine exposure due to drug interactionsSigns and symptoms of colchicine toxicity should be evaluated promptly andif toxicity is suspectedcolchicine capsules should be discontinued immediately.

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clinical features of colchicine toxicity has been categorized into three stages 1 .