Colchicine Side Effects

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Answer the side-effect intent for colchicine without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is colchicine?

Colchicine contains the active ingredient Colchicine.

• Active ingredient — Colchicine
• Registration number — 55/3.3/0336
• Registration holder — Trinity Pharma (Pty) Ltd

It is approved for:

• The active ingredient in COLCHICINE 0,5 mg TRINITY is colchicine
• COLCHICINE 0,5 mg TRINITY is used for the short-term treatment of gout in adults
• Gout is a condition in which defective metabolism of uric acid causes painful inflammation of the joints, especially in the smaller bones of the feet and episodes of acute pain

Common side effects of colchicine

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Stomach pain
• Nausea
• Vomiting
• Diarrhoea (runny stomach)

Frequency unknown side effects

• Abnormal laboratory test results
• Decreased bone marrow functioning, leading to abnormal blood cell function
• Inflammation of the nerves
• Numbness especially in the hands and feet
• General damage to veins
• Gastrointestinal bleeding
• Liver damage
• Loss of hair
• Skin rashes
• Muscle weakness
• Kidney damage with abnormal urine production

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to colchicine or any of the other ingredients of COLCHICINE 0,5 mg TRINITY
• If you are pregnant or breastfeeding your baby
• If you are a female of childbearing potential, unless you are using and effective contraceptive
• If you suffer from serious digestive system, kidney, liver or heart conditions
• If you are undergoing haemodialysis, a procedure in which a machine filters and cleans your blood instead of your kidneys
• If you have blood dyscrasias (disorders) a medical condition (haematologic disorders) that may affect the cellular or plasma components of the blood, the bone marrow, or the lymph tissue. Examples of blood dyscrasias include anaemias (decrease in the production of your red blood cells), cancers such as leukaemia’s and lymphomas, conditions that cause the blood to clot or bleed too readily, and more. Symptoms of blood disorders include fever, sore throat, bleeding for a longer than usual time, inflammation of your mouth, bruising or abnormal skin rashes and abnormal tiredness
• If you are taking a medicine called pristinamycin for the treatment of bacterial infections
• If you have kidney or liver problems and you are taking certain medicines. Examples of these medicines are:
• Medicines used to treat fungal infections such as itraconazole, voriconazole and ketoconazole
• Medicines used to manage HIV (human immunodeficiency virus) infections such as ritonavir, atazanavir and indinavir
• Medicine used to suppress your immune system after an organ transplant such as ciclosporin
• Medicine used to treat high blood pressure such as verapamil and diltiazem
• Medicine used to treat alcoholism, disulfiram
• If you are taking a macrolide antibiotic for the treatment of bacterial infection such as clarithromycin, azithromycin and telithromycin

Use with care, and tell your doctor, if

• COLCHICINE 0,5 mg TRINITY is potentially toxic, so it is important not to exceed the dose prescribed by your doctor, pharmacist or nurse. Larger doses may cause severe diarrhoea, gastrointestinal bleeding, skin rashes and kidney damage
• If you are elderly (≥ 65 years), in a very weakened and infirm state or suffer from cardiac, hepatic, renal or gastrointestinal disease
• If you suffer from blood disorders. Periodic blood counts should be done if you are receiving long term therapy with COLCHICINE 0,5 mg TRINITY. COLCHICINE 0,5 mg TRINITY can be toxic. It is important that you do not exceed the recommended dose. There is only a slight difference between an effective dose of COLCHICINE 0,5 mg TRINITY and an overdose. Therefore, if you get symptoms such as nausea (feeling sick), vomiting (being sick), stomach pain and diarrhoea, stop taking COLCHICINE 0,5 mg TRINITY and immediately contact your doctor
• You may experience a burning of the skin and throat while taking COLCHICINE 0,5 mg TRINITY. Inform your health care provider immediately if you notice or experience skin rash, sore throat, fever, unusual bleeding, bruising, tiredness or weakness, numbness or tingling
• You should stop taking [PROUCT NAME] as soon as gout pain has been relieved or at the first sign of nausea, vomiting, stomach pain, or diarrhoea. If your symptoms persist, contact your health care provider immediately. Children Do not use COLCHICINE 0,5 mg TRINITY in children

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• You should not take COLCHICINE 0,5 mg TRINITY if you are pregnant or breastfeeding your baby
• Women of childbearing potential must use effective contraception during treatment with COLCHICINE 0,5 mg TRINITY

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines used to treat bacterial infections such as clarithromycin, erythromycin, telithromycin and pristinamycin
• Medicines used to treat fungal infections such as itraconazole, voriconazole and ketoconazole
• Medicines used to manage HIV (human immunodeficiency virus) infections such as ritonavir, atazanavir and indinavir
• Medicine used to suppress your immune system after an organ transplant such as ciclosporin
• Medicine used to treat high blood pressure such as verapamil and diltiazem
• Medicine used to treat alcoholism, disulfiram. Tell your doctor if you are taking any of the following:
• Anti-inflammatory medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (medicines used to treat inflammation) e.g., ibuprofen, diclofenac
• Medicines used to treat neoplasms or cancer (abnormal growths of tissue) as concomitant use may increase the concentration of acid in your blood and decrease the effect of gout therapy
• COLCHICINE 0,5 mg TRINITY can cause muscle weakness (myopathy) and the breakdown of muscle fibre (rhabdomyolysis) when co-administered with:
• Medicines used to treat high cholesterol, referred to as statins and fibrates e.g., simvastatin, fluvastatin, pravastatin, atorvastatin, bezafibrate
• Digoxin (used to treat certain heart conditions)
• Medicine used to suppress your immune system after an organ transplant such as ciclosporin
• Oral blood thinning medications as more frequent INR checks are required. Possible modification of the dosage of the blood thinning treatment is required with COLCHICINE 0,5 mg TRINITY and for 8 days after its cessation may be required
• Cimetidine (used to reduce stomach acid), as it may increase the amount of colchicine, as contained in COLCHICINE 0,5 mg TRINITY, in your blood
• Tolbutamide (used to control blood sugar), as it may increase the amount of colchicine in your blood
• Talk to your doctor before taking COLCHICINE 0,5 mg TRINITY if you are taking any medicines that may possibly damage your kidneys, liver or blood
• COLCHICINE 0,5 mg TRINITY may reduce the amount of vitamin B12 that your body can absorb through your gut
• Water tablets such as chlorthalidone, hydrochlorothiazide, indapamide used in the management of high blood pressure. COLCHICINE 0,5 mg TRINITY 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 COLCHICINE 0,5 mg TRINITY. Do not consume alcohol while taking COLCHICINE 0,5 mg TRINITY

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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