Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The active ingredient in Colchicine tablets is colchicine, which is an anti-gout agent. Colchicine tablets are used to treat gout attacks. They are also used to prevent flare-ups of gout when treatment is started with other medicines such as allopurinol, probenecid and sulfinpyrazone.
Do not take Colchicine tablets if you:
• are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6) • have a severe blood disorder • are pregnant • are breast-feeding • are a woman of childbearing age, unless you are using effective contraception • have severe kidney or liver problems • are undergoing haemodialysis • have kidney or liver problems and you are taking certain medicines (see 'Other medicines and Colchicine tablets')
If you are not sure whether any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions Talk to your doctor or pharmacist before taking Colchicine tablets if you:
• have problems with your heart, kidneys, liver or digestive system • are elderly and weak • have a blood disorder
Colchicine tablets can be toxic, so it is important that you do not exceed the dose prescribed by your doctor.
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Colchicine 500 microgram tablets
Colchicine tablets can cause a serious decrease in bone marrow function leading to a decrease in certain white blood cells (agranulocytosis), a decrease in red blood cells and pigment (aplastic anaemia) and/or a low blood platelet count (thrombocytopenia). You should have regular blood tests to monitor any changes.
If you develop symptoms such as fever, inflammation of the mouth, sore throat, prolonged bleeding, bruising or skin problems, stop taking this medicine and contact your doctor immediately. These could be signs that you have a serious blood problem and your doctor may want you to have blood tests straight away (see also section 4 'Possible side effects').
Other medicines and Colchicine tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking another medicine whilst you are taking Colchicine tablets can affect how they or the other medicine works.
When Colchicine tablets are taken together with any of the following medicines, side effects due to colchicine toxicity are more likely and these can be serious and life-threatening:
• Certain antibiotics such as clarithromycin, erythromycin and telithromycin (used to treat infections) • Anti-viral medicines such as ritonavir, atazanavir and indinavir (used to treat HIV infection) • Ciclosporin (used to prevent organ rejection after a transplant, psoriasis and rheumatoid arthritis) • Anti-fungal medicines such as ketoconazole, itraconazole and voriconazole • Certain heart medicines such as verapamil and diltiazem • Disulfiram (used to help treat alcoholism)
If you are taking any of the above medicines, your doctor may want to adjust your dose of Colchicine tablets or temporarily stop your treatment with Colchicine tablets. If you have liver or kidney problems and you are taking any of the above medicines, you should not take Colchicine tablets.
It is also important to tell your doctor or pharmacist if you are taking any of the following medicines:
This medicine may reduce the amount of vitamin B12 that your body can absorb through your gut.
Colchicine tablets with food and drink Grapefruit juice may increase the amount of colchicine in your blood. Therefore, you should not drink grapefruit juice whilst you are taking this medicine.
Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, do not take this medicine. If you are a woman of childbearing potential, do not take this medicine unless you are using effective contraception. Colchicine passes into breast milk. If you are breast-feeding, do not take this medicine.
Driving and using machines
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There is only a slight difference between an effective dose of Colchicine tablets and an overdose. Therefore, if you get symptoms such as nausea (feeling sick), vomiting (being sick), stomach pain and diarrhoea, stop taking this medicine and immediately contact your doctor (see also section 4 'Possible side effects').
• Cimetidine (used to reduce stomach acid), as it may increase the amount of colchicine in your blood • Tolbutamide (used to control blood sugar), as it may increase the amount of colchicine in your blood • Digoxin (used to treat certain heart conditions) and 'fibrates' (medicines used to lower cholesterol), as they may increase your risk of a muscle disease known as 'rhabdomyolysis'. Taking Colchicine tablets together with ciclosporin or 'statins' also increases your risk of developing this disease.
Talk to your doctor before taking Colchicine tablets if you are taking any medicines that may possibly damage your kidneys, liver or blood. Check with your doctor if you are not sure.
The possibility of drowsiness (sleepiness) and dizziness should be taken into account. If affected, do not drive or operate machinery.
Colchicine tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Colchicine tablets contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many tablets to take and for how long you should take them. Colchicine tablets should be swallowed whole with a glass of water.
Dose to prevent flare-ups of gout when treatment is started with other medicines: The recommended dose is 1 tablet twice daily. Your doctor will tell you how long your treatment with Colchicine tablets will last.
If you have kidney or liver problems Your doctor may reduce your dose of Colchicine tablets, and you should be carefully monitored for side effects. Do not take this medicine if you have severe kidney or liver problems.
If you take more Colchicine tablets than you should If you take more tablets than you are supposed to, contact your doctor or nearest hospital accident and emergency department immediately. Take this leaflet and any Colchicine tablets you have left with you. At too high dose Colchicine tablets can be seriously toxic, even fatal. Early symptoms of overdose (which appear on average after 3 hours but can take longer) may include nausea, vomiting, stomach pain, bloody diarrhoea and low blood pressure.
If you forget to take Colchicine tablets If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet. Do not take Colchicine tablets with a shorter interval than prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking this medicine and immediately contact a doctor or the nearest hospital accident and emergency department:
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Use in adults Dose to treat gout attack: The recommended dose is two to four (2-4) tablets daily until symptoms are relieved or when a total of twelve (12) colchicine tablets have been taken. You should not take more than twelve (12) colchicine tablets as a course of treatment. After completion of a course of colchicine tablets, you should not start another course for at least three days.
• Nausea (feeling sick), vomiting (being sick), stomach pain and diarrhoea (see also section 2 'Warnings and precautions'). These side effects are common (may affect up to 1 in 10 people).
Other side effects that have been seen (with unknown frequency) are:
• Inflammation of the nerves which can cause pain, weakness, tingling or numbness • Nerve damage • Gastrointestinal bleeding • Liver damage • Hair loss • Rash • Pain or weakness in muscles • Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis) • Kidney damage • Absence of menstrual periods • Painful periods • Reduced ability to produce sperm (low or zero sperm count)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.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.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton, label or blister after EXP. The expiry date refers to the last day of that month.
Do not take Colchicine tablets if you notice that they are showing signs of deterioration such as discolouration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Colchicine tablets contain The active substance is colchicine. Each tablet contains 500 micrograms of colchicine. The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.
Marketing Authorisation Holder Viatris, Station Close,
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• Symptoms such as fever, inflammation of the mouth, sore throat, prolonged bleeding, bruising or skin problems. These could be signs that you have a serious blood problem as a result of bone marrow depression (see also section 2 'Warnings and precautions'). The frequency of these side effects is not known (cannot be estimated from the available data).
This medicine does not require any special storage conditions. Store in the original package in order to protect from light.
What Colchicine tablets looks like and contents of the pack Colchicine 500 microgram tablets are white to pale yellow colour, 6.0 mm ± 0.5 mm round flat beveled edged, uncoated tablets debossed with "C 75" on one side and plain on the other side. Pack containing 100 tablets are available.
Potters Bar, EN6 1TL, United Kingdom.
Manufacturer Viatris UK Healthcare Limited, 20 Station Close, Potters Bar, EN6 1TL, United Kingdom.
Mylan Hungary Ltd., Mylan utca 1., Komarom, 2900, Hungary
This leaflet was last revised in 05/2026.
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Colchicine 500 microgram Tablets comes as tablet containing 500mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Colchicine 500 microgram Tablets is colchicine.
Medicines with the same active substance, strength and form include: Colchicine 500 mcg Tablets, Colchicine 500 microgram tablets, Colchicine 500 micrograms Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Colchicine 500 microgram Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Adults
• Treatment of acute gout.
• Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs.
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. Such patients should be carefully monitored for adverse effects of colchicine (see also section 5.2).
For patients with severe renal impairment, see section 4.3.
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.
For patients with severe hepatic impairment, see section 4.3.
Elderly
Use with caution.
Method of administration
Oral route.
Tablet should be swallowed with a glass of water.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• 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.
• Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor (see section 4.5)
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.
Caution is advised in case of:
• Liver or renal impairment
• Cardiovascular disease
• Gastrointestinal disorders
• Elderly and debilitated patients
• Patients with abnormalities in blood counts
Patients with liver or renal impairment should be carefully monitored for adverse effects of colchicine (see section 5.2).
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. If treatment with a P-gp inhibitor or a moderate or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, a reduction in colchicine dosage or interruption of colchicine treatment is recommended (see section 4.5).
This medicine contains lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 increase. Toxicity, including fatal cases, have been reported during concurrent use of CYP3A4 or P-gp inhibitors such as macrolides (clarithromycin and erythromycin), ciclosporin, ketoconazole, itraconazole, voriconazole, HIV protease inhibitors, calcium channel blockers (verapamil and diltiazem) and disulfiram (see section 4.4).
Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-gp inhibitor (e.g. ciclosporin, verapamil or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketoconazole) (see section 4.3).
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-gp inhibitor or strong CYP3A4 inhibitor is required (see section 4.4).
A 4-fold reduction in colchicine dosage is recommended when co-administered with a P-gp inhibitor and/or a strong CYP3A4 inhibitor. A 2-fold reduction in colchicine dosage is recommended when co-administered with a moderate CYP3A4 inhibitor.
The magnitude of interactions with strong and moderate CYP3A4 inhibitors as well as with P-gp inhibitors from performed in vivo studies is summarised in the table below:
Single dose of 0.6 mg colchicine without or with:
Number of subjects
% change in colchicine pharmacokinetic parameters
Guidance for dose reduction:
Cmax
AUCo-t
Strong CYP3A4 inhibitors
Clarithromycin 250 mg twice daily for 7 days
Ketoconazole 200 mg twice daily for 5 days
Ritonavir 100 mg twice daily for 5 days
N=23
N=24
N=18
297
190
267
339
287
345
4-fold
Acute gout regimen to be repeated no earlier than 3 days.
Moderate CYP3A4 inhibitors
Verapamil ER 240 mg once daily for 5 days
Diltiazem ER 240 mg once daily for 7 days
Grapefruit juice 240 ml twice daily for 4 days
N=24
N=20
N=21
130
129
93
188
177
95
2-fold
Acute gout regimen to be repeated no earlier than 3 days.
Potent P-gp inhibitors
Cyclosporin 100 mg single dose
N=23
324
317
4-fold
Acute gout regimen to be repeated no earlier than 3 days.
Given the nature of the side effects, caution is advised with concomitant administration of drugs that can affect the blood count or have a negative effect on hepatic and/or renal function.
In addition, substances such as cimetidine and tolbutamide reduce metabolism of colchicine and thus plasma levels of colchicine increase.
Grapefruit juice may increase plasma levels of colchicine. Grapefruit juice should therefore not be taken together with colchicine.
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
Colchicine administration in animals induces significant reductions in fertility.
Pregnancy
Colchicine is genotoxic in vitro and in vivo and is teratogenic in animal studies (see section 5.3). Colchicine is therefore contraindicated in pregnancy (see section 4.3).
Women of childbearing potential have to use effective contraception during treatment.
Breastfeeding
Colchicine is excreted in breast milk. Therefore, use of colchicine is contraindicated in women who are breastfeeding (see section 4.3).
No details are available regarding the influence of colchicine on the ability to drive and use machines. However, the possibility of drowsiness and dizziness should be taken into account.
The following adverse reactions have been observed.The frequencies are listed under one of the following classifications:
Very common > 1/10Common > 1/100 and < 1/10Uncommon > 1/1,000 and < 1/100Rare >1/10,000 and < 1/1,000Very 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 colchicine overdose, all patients, even in the absence of early symptoms, should be referred for immediate medical assessment.
Clinical
Symptoms of acute overdosage may be delayed (3 hours on average): nausea, vomiting, abdominal pain, haemorrhagic 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.
Treatment
No antidote is available.
Elimination of toxins by gastric lavage within one hour of acute poisoning.
Consider oral activated charcoal in adults who have ingested more than 0.1mg/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 widely (7-65 mg single dose) for adults but is generally about 20 mg.
Ask anything about Colchicine 500 microgram Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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