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In the event of diarrhoea, treatment must be discontinued or the dose reduced.
Treatment with colchicine in the elderly, children and debilitated patients, or those who abuse alcohol, must be closely monitored due to the higher risk of cumulative toxicity in these populations.
Leukopoenia, granulocytopoenia, pancytopoenia, aplastic anaemia and myelosuppression have all been associated with the use of colchicine at therapeutic doses, so possible side effects must be monitored and patients must undergo regular blood tests.
A dose adjustment may be required in patients with hepatobiliary and renal impairment. Patients must be closely monitored during treatment of acute gout attacks due to the possibility of renal or hepatobiliary impairment.
Colchicine is significantly excreted in the urine of healthy individuals. Colchicine clearance is diminished in patients with renal impairment. Total body clearance of colchicine is reduced by up to 75% in patients with renal disease undergoing dialysis (see Pharmacology: Pharmacokinetics under Actions).
As colchicine may not be cleared in patients undergoing dialysis, its use would be contraindicated (see Contraindications).
Colchicine clearance may be significantly reduced and its plasma half-life increased in patients with hepatic insufficiency.
Neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment at therapeutic doses. This risk may be increased in patients with renal failure and in the elderly (even those with no hepatic or renal impairment).
Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid or bezafibrate (all of which are associated with myotoxicity), digoxin or cyclosporine with colchicine may promote the appearance of myopathies (see Interactions). Once treatment with colchicine has been discontinued, the symptoms usually subside in a period of between one week and several months.
Warning about the excipients: This medicinal product contains lactose. Patients with a hereditary galactose intolerance, Lapp lactase deficiency (deficiency observed in some towns in Lapland) or glucose-galactose malabsorption should not take this medicinal product.
This medicinal product contains methylene casein. Patients who are allergic or intolerant to cow milk protein must not take this medicinal product.
Effects on ability to drive and use machines: This medicinal product has no influence on the ability to drive and use machines.
