COLCEE

5 mg, possibly preceded by an initial dose of 1 mg. Treatment should end until the acute attack resolves, or earlier in the event of gastrointestinal symptoms and no improvement after 2 to 3 days. No more than 6 mg should be taken as a course of treatment.

After completion of a course, another course should not be started for at least 3 days (72 hours). If diarrhoea or vomiting occurs, Colcee1000 microgram 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 Colcee 1000 microgram Tablets 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.

5 mg per day and should be carefully monitored for adverse effects of colchicine. 5 mg per day and should be carefully monitored for adverse effects of colchicine. 3 contraindications. Method of Administration Oral route. Tablet should be swallowed with a glass of water.

The following adverse reactions have been observed. The frequencies are unknown, unless 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) Blood and lymphatic system disorders Bone marrow depression with agranulocytosis and aplastic anaemia.

Nervous system disorders Peripheral neuritis, neuropathy Gastrointestinal disorders Common: abdominal pain, nausea, vomiting and diarrhoea Hepatobiliary disorders Not known: hepatotoxicity Renal and urinary disorders Not known: renal damage.

Skin and subcutaneous tissue disorders Alopecia, rash Musculoskeletal and connective tissue disorders Myopathy and rhabdomyolysis Reproductive system and breast disorders Amenorrhoea, dysmenorrhoea, oligospermia, azoospermia Respiratory, thoracic en mediastinal disorders Pharyngolaryngeal pain Metabolism and nutrition disorders Vitamin B12 deficiency 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. By reporting side effects you can help provide more information on the safety of this medicine

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 disease – 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.

1 – Patients with blood dyscrasias – Patients with severe renal impairment – Patients with severe hepatic impairment