Indications: Adults: The treatment of acute gout, the prophylaxis of a gout attack during initiation of urate-lowering therapy. The treatment of acute and recurrent Pericarditis, as an adjunct to aspirin/NSAID therapy. Adults and paediatric patients: Familial Mediterranean Fever (FMF) for prophylaxis of attacks and prevention of amyloidosis. Dosage and method of administration: Acute gout attack (Adults): 500 micrograms (2 ml) 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 6,000 micrograms (24 ml) have been taken. No more than 6,000 micrograms (24 ml) 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, Colchicine should be discontinued immediately as these may be the first signs of an intoxication. Prophylaxis of gout attack (Adults): 500 micrograms – 1,000 micrograms per day (2 – 4 ml/day) to be taken in the evening. Acute and Recurrent Pericarditis (Adults): The recommended dose is 500 micrograms/day (2 ml/day) for patients weighing ≤70kg or in patients with intolerance to higher doses. The recommended dose is 500 micrograms (2 ml) twice daily for patients with a body weight of >70 kg. Treatment duration is 6 months in recurrent pericarditis and 3 months in acute pericarditis. Familial Mediterranean Fever: The dose may be given as a single dose or doses higher than 1,000 micrograms/day (4ml/day) may be divided and given twice daily. Colchicine dosage should be increased in a stepwise fashion up to a maximum of 3,000 micrograms/day (12 ml/day) to control disease in patients who do not clinically respond to the standard dosage. Any increase of the daily dose should be monitored closely for adverse effects. Careful monitoring is needed in the presence of impaired renal or liver function. For these patients, the starting dose should be reduced by 50% (e.g. ≤ 1,000 micrograms/day, 4 ml). Adults: 1,000 to 3,000 micrograms per day (4 to 12 ml per day). Paediatric population: For paediatric use, colchicine should only be prescribed under the supervision of a medical specialist with the necessary knowledge and experience. A starting dose should be administered orally based on age: 500 micrograms/day (2 ml/day) in children less than 5 years of age. 1,000 micrograms/day (4 ml/day) in children from 5 to 10 years of age. 1,500 micrograms/day (6 ml/day) in children over 10 years of age. In children with amyloid nephropathy, higher daily doses up to 2,000 micrograms/day (8 ml/day) might be needed. Colchicine dosage should be increased in a stepwise fashion (e.g. 250 micrograms/step) up to a maximum of 2,000 micrograms/day to control disease in patients who do not clinically respond to the standard dosage. Any increase of the daily dose should be monitored closely for adverse effects. 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. In patients with mild and moderate renal impairment, the dose is 500 micrograms (2mL oral solution) per day in gout, acute and recurrent pericarditis and the starting dose should be reduced by 50% (e.g. ≤ 1,000 micrograms/day) in FMF. The dose should be carefully monitored for adverse effects of colchicine. Patients with any degree of renal impairment should not be given colchicine in conjunction with strong P-glycoprotein inhibitors or strong CYP3A4 inhibitors. In patients with mild and moderate hepatic impairment, the dose is 500 micrograms (2 mL oral solution) per day in gout, acute and recurrent pericarditis and the starting dose should be reduced by 50% (e.g. ≤ 1,000 micrograms/day) in FMF. The dose should be carefully monitored for adverse effects of colchicine. Patients with any degree of hepatic impairment should not be given colchicine in conjunction with strong P-glycoprotein inhibitors or strong CYP3A4 inhibitors. Method of Administration: Colchicine is for oral use only. The oral solution should be considered especially for children younger than 1 year. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Patients with blood dyscrasias, severe renal impairment, severe hepatic impairment. Special warnings and precautions for use: Colchicine is potentially toxic, do not exceed the dose prescribed by a medical specialist with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. Discontinue administration if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur. Colchicine in patients with pre-existing blood dyscrasias, gastrointestinal disease, elevated aminotransferase, creatinine or troponin levels, severe liver disease, myopathy, bacterial or neoplastic pericarditis should not be used due to the increased risk of developing neuromuscular toxicity. If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, or prolonged bleeding, 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, pregnant or lactating women. Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia). Change in blood counts may be gradual or very sudden. Aplastic anaemia has a high mortality rate. Periodic checks of the blood count are essential. If skin abnormalities (petechiae) occur, blood counts should be checked immediately. Macrolides, CYP3A4 inhibitors, ciclosporin, HIV protease inhibitors, calcium channel blockers, and statins may cause clinically significant interactions with colchicine which may lead to colchicine-induced toxicity. 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. If treatment with a P-gp inhibitor or a strong CYP3A4 inhibitor is required in patients with normal renal and or hepatic function, a reduction in colchicine dosage is recommended and monitor 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 exceptional cases where continuation of colchicine when starting P-gp inhibitors and/or strong CYP3A4 inhibitors are considered a benefit, significant dose reductions of colchicine dose and careful clinical monitoring should be applied. Long-term use of colchicine may be associated with vitamin B12 deficiency. In case colchicine is used for treatment of acute gout or for prophylaxis of a gout attack during initiation of urate-lowering therapy: Patients should be informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed. Female patients should use effective contraception during and for at least three months following termination of colchicine therapy. Based on concerns about a potential damage to sperm cells, male patients should not father a child during and for at least 6 months following termination of colchicine therapy. No long-term safety data are available in paediatric patients. The use of colchicine in children is primarily indicated for the indication FMF. Safety and effectiveness in paediatric patients have not been established in indications acute gout, prophylaxis of a gout attack and acute/recurrent pericarditis. Clinical trial data showed a trend for an increased risk of non-cardiovascular death in patients treated with colchicine. Caution should be exercised in colchicine-treated patients with chronic coronary disease and with comorbidities that may underlie potential causes of mortality. Potential benefits and risks should always be weighed, and the patients should be carefully monitored for any signs or symptoms of toxicity. This medicine contains Sodium methyl parahydroxybenzoate as an excipient. May cause allergic reactions (possibly delayed). This medicine contains less than 1 mmol sodium (23 mg) per 1ml of solution, essentially ‘sodium-free’. Interaction with other medicinal products and other forms of interaction: Interactions with other drugs are not or scarcely documented. Caution is advised with concomitant administration of drugs that affect blood count or have negative effects on hepatic and/or renal function. Substances such as cimetidine and tolbutamide may reduce metabolism of colchicine, increasing plasma levels of colchicine. Colchicine is a substrate for both CYP3A4 and the transport protein P-gp. In the presence of CYP3A4 or P-gp inhibitors, the concentrations of colchicine in the blood may increase. Toxicity, including fatal cases, have been reported during concurrent use of inhibitors such as macrolides (clarithromycin and erythromycin), ciclosporin, ketoconazole, itraconazole, voriconazole, HIV protease inhibitors, calcium channel antagonists such as verapamil and diltiazem. It has been reported that coadministration of azithromycin with colchicine leads to increased serum levels of colchicine. During treatment with azithromycin and after discontinuation, clinical follow-up, and potentially follow-up of serum levels of colchicine, is required. Grapefruit juice may increase plasma levels of colchicine and should not be taken together with colchicine. If treatment with a P-gp inhibitor (e.g. ciclosporin, verapamil or quinidine) or strong CYP3A4 inhibitor (e.g. ritonavir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketoconazole) is required in patients with normal renal or hepatic function, adjustment of colchicine dosage may be necessary. Concurrent use of such inhibitors and colchicine should be avoided in patients with renal or hepatic damage. Reversible malabsorption of cyanocobalamin (Vitamin B12) may be induced by an altered function of the intestinal mucosa. The risk of myopathy and rhabdomyolysis is increased by a combination of colchicine with statins, fibrates, ciclosporin or digoxin. Fertility, pregnancy and lactation Animal research has shown that colchicine administration may negatively influence spermatogenesis. Rare cases of reversible oligospermia and azoospermia in men are known from literature. In case Colchicine is used for treatment of FMF: Since the course of FMF without treatment may also lead to infertility, the use of colchicine should be weighed against the potential risks and may be considered, if clinically needed. In case colchicine is used for treatment of acute gout or for prophylaxis of a gout attack during initiation of urate-lowering therapy: Male patients should not father a child during and for at least 6 months following termination of colchicine therapy. If pregnancy occurs during this time, genetic counselling should be tasked. Pregnancy: Animal studies denote reproductive toxicity. In case colchicine is used for treatment of FMF: A moderate amount of data on pregnant women with FMF indicate no malformative or feto/ neonatal toxicity of colchicine. Since the course of FMF without treatment may also negatively influence pregnancy, the use of colchicine during pregnancy should be weighed against the potential risks and may be considered, if clinically needed. In case colchicine is used for treatment of acute gout or for prophylaxis of a gout attack during initiation of urate-lowering therapy: There is a limited amount of data from the use of colchicine in pregnant women with gout. As a precautionary measure, use of colchicine in this patient population and in women of childbearing potential not using effective contraception, should be avoided and may only be considered if other treatment options, including NSAIDs and glucocorticoids, are not applicable. Female patients must use effective contraception during and for at least three months following termination of colchicine therapy. If pregnancy occurs during this time, genetic counselling should be tasked. Breast-feeding: Colchicine/metabolites is /are found in breastfed newborns/infants of treated women. There is insufficient information on the effects of colchicine in newborns/infants. Colchicine should not be used in breast-feeding women with gout. In lactating mothers with FMF, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Colchicine therapy considering the benefit of breast feeding for the child and the benefit of therapy for the woman. Effects on ability to drive and use machines: No data are available regarding the influence of colchicine on the ability to drive and use machines. The possibility of drowsiness and dizziness should be considered. Undesirable effects: For a full list of side effects, consult the SmPC. Common (≥1/100 to <1/10): Abdominal pain, nausea, vomiting and diarrhoea. Serious, frequency not known (Cannot be estimated from the available data): Bone marrow depression with agranulocytosis, aplastic anaemia, pancytopenia, neutropenia, thrombocytopenia, leukopenia. Peripheral neuritis, neuropathy. Hepatotoxicity, rhabdomyolysis. Overdose: Colchicine has a narrow therapeutic window and is extremely toxic in overdose. Patients at particular risk of toxicity are those with renal or hepatic impairment, gastro-intestinal or cardiac disease and patients at extremes of age. Following overdose, all patients, even in the absence of early symptoms should be referred for immediate medical assessment. Symptoms of acute overdosage may be delayed (3 hours on average): nausea, vomiting, abdominal pain, hemorrhagic gastroenteritis, volume depletion, electrolyte abnormalities, leukocytosis, hypotension in severe cases. The second phase with life threatening complications develops 24 to 72 hours after drug administration: multisystem organ dysfunction, acute renal failure, confusion, coma, ascending peripheral motor and sensory neuropathy, myocardial depression, pancytopenia, dysrhythmias, respiratory failure, consumption coagulopathy. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery may be accompanied by rebound leukocytosis and reversible alopecia starting about one week after the initial ingestion. No antidote is available. Elimination of toxins by gastric lavage within one hour of acute poisoning. Consider oral activate charcoals in adults who have ingested more than 0.1 mg/kg bodyweight within 1 hour of presentation and in children who have ingested any amount within 1 hour of presentation. Haemodialysis has no efficacy (high apparent distribution volume). Close clinical and biological monitoring in hospital environment. Symptomatic and supportive treatment: control of respiration, maintenance of blood pressure and circulation, correction of fluid and electrolytes imbalance. The lethal dose varies strongly (7 – 65 mg in one dose), but for adults it is generally about 20 mg. MA number: PL 35533/0239. Cost: 75ml: £190.40. MAH: Aspire Pharma Limited, 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom. Legal Category: POM. Version number: MAT-UK-COL-0001-1 | March 2026