YSP Colchicine Special Precautions

Colchicine is potentially toxic so it is important not to exceed the dose prescribed. Colchicine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain and diarrhea occur. Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, and thrombocytopenia). The change in blood count may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood picture are essential.
If patients develop sign and symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, prolonged bleeding, bruising, or skin disorders, treatment with colchicine should be immediately discontinued and a full haematological investigation should be conducted straight away.
Caution is advised in case of: Liver or renal impairment; Cardiovascular disease; Gastrointestinal disorders; Elderly and debilitated patients; Patients with abnormalities in blood counts.
Co-administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine-induced toxicity including fatalities. If treatment with a P-gp inhibitor or a moderate or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, a reduction in colchicine dosage or interruption of colchicine treatment is recommended.
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on Ability to Drive and Use Machine: No data are available regarding the influence of colchicine on the ability to drive and use machines.
However, the possibility of drowsiness and dizziness should be taken into account.