COLCHICINE

Posology Adults Treatment of acute gout attack:

One 500 microgram tablet two to four (2-4) times daily until symptoms are relieved. The course of treatment should end when symptoms are relieved or when a total of 6 mg (twelve 500 microgram tablets) have been taken. No more than 6 mg of colchicine tablets should be taken as a course of treatment.

After completion of a course, another course should not be started for at least three days (72 hours). Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs: 500 micrograms twice daily. The treatment duration should be decided after factors such as flare frequency, gout duration and the presence and size of tophi have been assessed.

Patients with renal impairment Use with caution in patients with mild renal impairment. For patients with moderate renal impairment, reduce dose or increase interval between doses. 2). For patients with severe renal impairment, see section

The following adverse reactions have been observed.

The frequencies are listed under one of the following classifications:

Very common > 1/10 Common > 1/100 and < 1/10 Uncommon > 1/1,000 and < 1/100 Rare >1/10,000 and < 1/1,000 Very rare < 1/10,000 Not known (cannot be estimated from the available data) Blood and lymphatic system disorders Not known: bone marrow depression with agranulocytosis, aplastic anaemia and thrombocytopenia.

Nervous system disorders Not known: peripheral neuritis, neuropathy. Gastrointestinal system disorders Common: abdominal pain, nausea, vomiting and diarrhoea. Not known: gastrointestinal haemorrhage. Hepatobiliary disorders Not known: hepatotoxicity.

Skin and subcutaneous tissue disorders Not known: alopecia, rash. Musculoskeletal and connective tissue disorders Not known: myopathy and rhabdomyolysis. Renal and urinary disorders Not known: renal damage. Reproductive system and breast disorders Not known: amenorrhoea, dysmenorrhoea, oligospermia, azoospermia.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Colchicine is potentially toxic, so it is important not to exceed the dose prescribed by a physician with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur.

Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia). The change in blood counts 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 signs or 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.

2). 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. 5). This medicine contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

3. Patients with hepatic impairment Use with caution in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for adverse effects of colchicine. 3. Elderly Use with caution. Method of administration Oral route.

Tablet should be swallowed with a glass of water. 1. • Patients with blood dyscrasias • Pregnancy • Breastfeeding • Women of childbearing potential unless using effective contraceptive measures • Patients with severe renal impairment • Patients with severe hepatic impairment • Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.

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