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. Treatment should be stopped earlier in the event of gastrointestinal symptoms or no improvement of the condition after 2 to 3 days.

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). If diarrhoea or vomiting occurs, Colchicine Tablets should be discontinued immediately as these may be the first signs of an intoxication.

5 – 1 mg per day (to be taken in the evening). Paediatric population Colchicine should not be used in children and adolescents. Specific groups Concomitant treatment of colchicine with several drugs, mostly inhibitors of cytochrome P450 3A4 (CYP3A4)/P-glycoprotein have been shown to increase the risk for colchicine toxicity.

If a patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or with a P-glycoprotein inhibitor, the maximum recommended dosage of oral colchicine should be reduced and should be carefully monitored for adverse effects of colchicine.

5 mg per day and should be carefully monitored for adverse effects of colchicine. 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, < 1/10) Uncommon (≥ 1/1,000, < 1/100) Rare (≥ 1/10,000, < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) Blood and lymphatic system disorders Not known: bone marrow depression with agranulocytosis, aplastic anemia and thrombocytopenia.

Nervous system disorders Not known: peripheral neuritis, neuropathy. Gastrointestinal system disorders Common: abdominal pain, nausea, vomiting and diarrhoea. Skin and subcutaneous tissue disorders Not known: alopecia, rash. Musculoskeletal and connective tissue disorders Not known: myopathy and rhabdomyolysis.

Reproductive system and breast disorders Not known: amenorrhoea, dysmenorrhoea, oligospermia, azoospermia.

Respiratory, thoracic and mediastinal disorders Not known:

Pharyngolaryngeal pain Metabolism and nutrition disorders Not known: Vitamin B12 deficiency Paediatric population No long-term safety data are available in paediatric patients. 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 medical specialist 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.

If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat or prolonged bleeding, treatment with colchicine should be immediately discontinued and a full haematological investigation should be conducted.

Caution is advised in case of: • liver or renal impairment • cardiovascular disease • gastrointestinal disorders • elderly and debilitated patients • patients with abnormalities in blood counts 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 count are essential. If skin abnormalities (petechiae) occur, blood counts should be checked immediately.

5). Co-administration with P-gp inhibitors and/or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine-induced toxicity including fatalities. 5) and patients should be carefully monitored for adverse effects of colchicine.

For patients with an impaired renal or hepatic function, the combined use of colchicine and P-gp inhibitors and/or strong CYP3A4 inhibitors should be avoided whenever possible, as it may be difficult to forecast and control systemic exposure to colchicine.

In those exceptional cases where continuation of colchicine when starting P-gp inhibitors and/or strong CYP3A4 inhibitors is considered a benefit, despite the potential risk of overdose, significant dose reductions of colchicine dose and careful clinical monitoring should be applied.

3. 5 mg per day and should be carefully monitored for adverse effects of colchicine. 3. Method of Administration For oral administration Tablets should be swallowed whole with a glass of water. 1 • Patients with blood dyscrasias • Patients with severe renal impairment • Patients with severe hepatic impairment