Patient leaflet - Colchicine 500 micrograms film-coated tablets
1. What Colchicine tablets are and what they are used for
The active ingredient in Colchicine tablets is colchicine. Colchicine is an anti-gout agent. Colchicine tablets are used to treat gout attacks in adults. They are also used to prevent flare-ups of gout in adults when treatment is started with other drugs such as allopurinol, probenecid and sulfinpyrazone.
2. What you need to know before you take Colchicine tablets
Ÿ If you have severe kidney or liver problems
Ÿ This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the same as yours.
Colchicine 500 microgram Film-coated Tablets
- 6. Contents of the pack and other information
Ÿ have problems with your heart, kidneys, liver or digestive system
Ÿ have a blood disorder
Ÿ If you have any further questions, ask your doctor or pharmacist.
What is in this leaflet
Ÿ If you are breastfeeding
If you are not sure whether any of the above apply to you, talk to your doctor or pharmacist before taking Colchicine 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.
- 1. What Colchicine tablets are and what they are used for
Ÿ If you are a woman of childbearing age, unless you are using
effective contraception
Do not take Colchicine tablets:
Ÿ If you are pregnant
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Ÿ If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
- 5. How to store Colchicine tablets
Colchicine
Package leaflet: Information for the patient
Ÿ Keep this leaflet. You may need to read it again.
- 3. How to take Colchicine tablets
- 4. Possible side effects
- 2. What you need to know before you take Colchicine tablets
Ÿ If you are allergic to colchicine or any of the other ingredients of
this medicine (listed in section 6).
Ÿ If you have a severe blood disorder.
Ÿ If you are undergoing haemodialysis
Ÿ If you have kidney or liver problems and you are taking certain
medicines (see 'Other medicines and Colchicine tablets').
Warnings and precautions
Talk to your doctor or pharmacist before taking Colchicine tablets if you:
Ÿ are elderly and weak
Colchicine tablets can be toxic so it is important that you do not exceed the dose prescribed by your doctor.
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 Colchicine tablets and immediately contact your doctor (see also section 4 'Possible effects').
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
The possibility of drowsiness and dizziness should be taken into account. If affected, do not drive or operate machinery. If you are pregnant, think you may be pregnant or are planning to have a baby, do not take this medicine.
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 Colchicine tablets.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Colchicine passes into breast milk. If you are breast feeding, do not take this medicine.
3. How to take Colchicine tablets
Driving and using machines
If you are a woman of childbearing potential, do not take this medicine unless you are using effective contraception.
Your doctor will tell you how many Colchicine tablets to take and for how long you should take them.
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 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:
Ÿ Certain antibiotics such as clarithromycin, erythromycin and telithromycin (used to treat infections).
Ÿ Anti-viral medicines such as ritonavir, atazanavir and indinavir
(used to treat HIV infection)
Ÿ Ciclosporin (used to prevent organ rejection after a transplant, psoriasis and rheumatoid arthritis)
Colchicine tablets with food and drink
Do not drink grapefruit juice whist you are taking Colchicine Tablets as it may increase the amount of colchicine in your blood. It is also important to tell your doctor or pharmacist if you are taking any of the following medicines:
Ÿ Anti-fungal medicines such as ketoconazole, itraconazole and voriconazole
Ÿ Tolbutamide (used to control blood sugar), as it may increase the amount of colchicine in your blood
Ÿ 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.
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. Do not take this medicine if you have liver or kidney problems and you are taking any of the above medicines.
Ÿ Certain heart medicines such as verapamil and diltiazem.
Pregnancy and breast-feeding
Ÿ Disulfram (used to help treat alcoholism)
Ÿ Cimetidine (used to reduce stomach acid), as it may increase the amount of colchicine in your blood
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.
Colchicine tablets may reduce the amount of vitamin B12 that your body can absorb through your gut.
Ÿ painful periods
Ÿ abnormal muscle breakdown which can lead to kidney problems
(rhabdomyolysis)
Ÿ reduced ability to produce sperm (low or zero sperm count) Ÿ kidney damage
Ÿ absence of menstrual periods
Your doctor may reduce your dose of Colchicine tablets, and you should be carefully monitored for side effects. Do not take Colchicine tablets if you have severe kidney or liver problems.
If you take more Colchicine tablets than you should
Too high dose of 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
Use in adults
Colchicine tablets should be swallowed whole with a glass of water.
Ÿ 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.
Ÿ After completion of a course of Colchicine tablets, you should not
start another course for at least three days.
Dose to treat gout attack:
The recommended dose to prevent flare-ups of gout when treatment is started with other medicines:
Ÿ The recommended dose is 500 micrograms of Colchicine tablets
twice daily. Your doctor will tell you how long your treatment with Colchicine tablets will last.
If you have kidney or liver problems
If you take more Colchicine 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.
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.
Ÿ 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) Like all medicines, this medicine can cause side effects, although not everybody gets them.
Other side effects that have been seen (with unknown frequency) are: Ÿ inflammation of the nerves which can cause pain, weakness,
tingling or numbness
4. Possible side effects
Ÿ nerve damage
Ÿ gastrointestinal bleeding
Ÿ liver damage
Ÿ hair loss
Ÿ rash
Ÿ pain or weakness in muscles
Ÿ 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).
If you notice any of the following side effects, stop taking Colchicine tablets and immediately contact a doctor or the nearest hospital accident and emergency department:
0 Do not store above 30 C.
Do not take Colchicine tablets if you notice that they are showing signs of deterioration such as discolouration.
High density polyethylene (HDPE) bottle with child-resistant closure containing 100 film-coated tablets and a silica gel desiccant. The product should be used within 100 days after opening of container.
Brown coloured, round shaped beveled edge, biconvex film coated tablets debossed with “I1” on one side and plain on other side. 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 reach and sight of children.
Do not take Colchicine tablets after the expiry date which is stated on the label. The expiry date refers to the last date of that month.
What Colchicine tablets contain
Reporting of side effects
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.
The active substance is colchicine. Each tablet contains
500micrograms of colchicine.
5. How to store Colchicine Tablets
- The other ingredients are: lactose monohydrate, crospovidone, microcrystalline cellulose and magnesium stearate which make up the tablet core and hypromellose (E464), polyethylene glycol (E1521), talc (E553b), titanium dioxide (E171), Iron oxide red (E172), Iron oxide yellow (E172) and Iron oxide black (E172) which make up the tablet coating. Refer to section 2 “Colchicine Tablets contains lactose”.
6. Contents of the pack and other information
What Colchicine tablets looks like and contents of the pack
Blister packs of opaque white or clear PVC / PVdC film and 25μ aluminium foil.
The following pack sizes are available: outer cartons containing blister packs of 20, 30, 40, 50, 60 & 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham, TS22 5TB
Synoptis Industrial Sp. z o.o.
United Kingdom
Manufacturer
This leaflet was last revised in 08/2025
ul. Rabowicka 15,
62-020 Swarzędz, Poland