COLCHICINA Ref.[4345] Active ingredients: Colchicine

Colchicine should be given with care to elderly and debilitated patients as there is a greater risk of cumulative toxicity.

Care should also be exercised in those with cardiac, hepatic, gastrointestinal disease or if patients are breast-feeding.
Colchicine should be avoided in patients with blood disorders.

Reduce dose in patients with mild to moderate renal impairment (see section 4.2 Posology and Method of Administration and section 4.3 Contraindications).

A reduction in Colchicine dosage or interruption of Colchicine treatment is recommended in patients with normal renal and hepatic function if treatment with a P-glycoprotein or a strong CYP3A4 inhibitor is required (see section 4.5, Interaction with other medicinal products and other forms of interaction).

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Antibacterials: increased risk of Colchicine toxicity when given with clarithromycin or erythromycin, particularly in patients with pre-existing renal impairment. Rare reports of fatalities (see section 4.3 Contraindications). AS CYP3A4 inhibitors, macrolides should not be used to treat patients with renal or hepatic impairment who are taking Colchicine (see section 4.3, Contraindications).

P-glycoprotein or strong CYP3A4 inhibitors: Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein inhibitor (e.g. ciclosporin, verapamil or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketaconazole) (see section 4.3, Contraindications).

A reduction in Colchicine dosage or an interruption of Colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with a P-glycoprotein or strong CYP3A4 inhibitor is required (see section 4.4, Special warnings and precautions for use.)

Ciclosporin: Colchicine should be used with caution with ciclosporin due to the possible increased risk of nephrotoxicity and myotoxicity.

Vitamins: the absorption of Vitamin B12 may be impaired by chronic administration or high doses of Colchicine; requirement may be increased.

Statins: Acute myopathy has been reported in patients given Colchicine with statins. Patients should be advised to report muscle pain or weakness.

Do not use in pregnancy as there is a risk of foetal chromosome damage.

Colchicine is distributed into breast milk. Colchicine may be used with caution during breast-feeding.

None known.

Colchicine frequently causes nausea, vomiting and abdominal pain. Larger doses may cause profuse diarrhoea, gastrointestinal haemorrhage, skin rashes and renal and hepatic damage.

Rarely peripheral neuritis, myopathy, rhabdomyolysis, alopecia, inhibition of spermatogenesis and, with prolonged treatment, bone marrow suppression with agranulocytosis, thrombocytopenia and aplastic anaemia occur.

None known.