Colcin ® 0,5 mg Tablets

The active ingredient in COLCIN tablets is colchicine. Colchicine is an anti-gout medicine. Colchicine helps to reduce the inflammation tenderness and swelling caused by gout in the joints. COLCIN tablets are used to treat acute attacks of gout in adults. COLCIN is not a painkiller and should not be used to treat other causes of pain.

Do not take COLCIN if you:

• are hypersensitive (allergic) to colchicine or any of the other ingredients of COLCIN (listed in section 6)
• if you are undergoing haemodialysis (a procedure in which a dialysis machine is used to clean your blood)
• if you suffer from severe liver or kidney impairment
• if you have blood disorders (low red or white cell count or problems with blood clotting, leukaemia). COLCIN may also cause a drop in red and white blood cell counts and platelet count (see Possible side effects). Your doctor will want to periodically measure these blood levels.
• if you are taking pristinamycin (a medicine used to treat bacterial infections)
• if you and have kidney and liver problems and also have to take certain other medicines (see Other medicines and COLCIN):
• Ciclosporin (used to prevent organ rejection after a transplant, psoriasis and rheumatoid arthritis)
• Verapamil and diltiazem (used to treat high blood pressure or angina)
• Quinidine (used to treat abnormal heart rhythms)
• Ritonavir, atazanavir or indinavir (used to treat HIV infection)
• Clarithromycin, erythromycin or telithromycin (so-called macrolide antibiotics, used to treat bacterial infections)
• Ketoconazole or itraconazole (used to treat fungal infections).
• if you are pregnant, may become pregnant, or breastfeeding your baby (see Pregnancy and breastfeeding)
• if you are a women of childbearing age, unless you are using effective contraception.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or professional healthcare provider.

Warnings and precautions

Take special care with COLCIN

• Do not take more than the recommended dose of COLCIN. If you experience nausea, vomiting, diarrhoea or stomach pain, stop taking COLCIN and contact your doctor.
• if you are an elderly (≥ 65 years) or debilitated patient (a patient with impaired energy or strength), as you may be more prone to the toxicity of COLCIN. Your healthcare provider will be monitoring you for toxicity and may decide to temporarily interrupt or discontinue your treatment with COLCIN at the first signs of toxicity, such as nausea, vomiting and diarrhoea.

Tell your doctor or healthcare provider before you start taking COLCIN tablets:

• if you have problems with your heart, kidneys, liver or digestive system - your dose may need to be reduced if you have kidney or liver problems;
• if you have ulcers or other serious gastrointestinal disorders, as these conditions may worsen when taking COLCIN;
• if you take other medicines that may cause muscle pain or damage, such as statins (for high blood cholesterol), as COLCIN may worsen these conditions (see Other medicines and COLCIN)
• if you have a blood disorder, as shown in laboratory tests. COLCIN 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 COLCIN 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 Possible side effects).

Children and adolescents

These tablets are not for use in children.

Other medicines and COLCIN

Always tell your healthcare professional if you are taking any other medicine. This includes complementary or traditional medicines.

Effects of other medicines on COLCIN: The following medicines may cause toxic concentrations of colchicine in your blood, which can be serious and life-threatening if you have kidney or liver disease (see “Do not take COLCIN”):

• Clarithromycin, erythromycin, telithromycin, roxithromycin or pristinamycin (antibiotics, used to treat infections)
• Ciclosporin (used to prevent organ rejection after a transplant, psoriasis and rheumatoid arthritis)
• Verapamil and diltiazem (used to treat high blood pressure or angina)
• Quinidine (medicine used to treat irregular heartbeat)
• Ritonavir, atazanavir and indinavir (used to treat HIV infection)
• Disulfiram (used to help treat alcoholism)
• Ketoconazole, itraconazole and voriconazole (used to treat fungal infections)
• Digoxin (medicine to treat irregular heartbeat).

Be careful with the following medicines. Tell your doctor or pharmacist if you are taking any of these:

• Statins e.g. simvastatin, fluvastatin, pravastatin, atorvastatin, bezafibrate (used to lower cholesterol). They may increase your risk of a muscle disease known as ‘rhabdomyolysis’ (the breakdown of muscle fibre)
• Anti-inflammatory medicines such as ibuprofen, diclofenac (used to treat inflammation) as the risk of side effects may be increased
• Water tablets such as chlorthalidone, hydrochlorothiazide, indapamide (used to treat high blood pressure)
• 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
• Medicines used in the treatment of cancer, as they may increase the amount of serum uric acid.

Talk to your doctor before taking COLCIN tablets if you are uncertain if you are taking any medicines that may possibly damage your kidneys, liver or blood. Your doctor will adjust your dose of COLCIN tablets or stop your treatment with COLCIN.

Effect of COLCIN on other medicines:

• Warfarin. COLCIN may increase the effect of oral blood thinners. Your doctor may want to change your dose of warfarin.
• COLCIN may reduce the amount of vitamin B12 that your body can absorb through your gut. You may need to increase your vitamin B12 dose.

Before you begin using any medicine (prescription or non-prescription), get advice from your doctor, pharmacist or healthcare provider.

COLCIN with food, drink and alcohol

Alcohol is a known trigger of gout; you should not take alcohol during an acute attack of gout. Having alcohol while taking COLCIN may also increase the risk of gastrointestinal side effects.

Grapefruit juice may increase the amount of colchicine in your blood. Therefore, you should not drink grapefruit juice while you are taking COLCIN.

Do not share medicines prescribed for you with any other person. Always take COLCIN exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are not sure. Do not exceed the prescribed dose of COLCIN as it is toxic in overdose.

The usual dose is:

It is very important that you strictly follow your doctor or pharmacist’s advice on the dose and for how long to take it. The usual dose is 0,5 mg to 1 mg (1 to 2 tablets) to be taken immediately, followed by 0,5 mg (1 tablet) every 2 hours until the pain is relieved, or if you develop nausea or diarrhoea. Do not take more than a total of 6 mg (12 tablets) per attack. Do not repeat the dose before 3 days (preferably 7 days) have passed. COLCIN tablets should be swallowed whole with a glass of water. If you are elderly, or have kidney problems, you may need a lower dose and you should be carefully monitored for side effects. Do not take COLCIN tablets if you have severe kidney or liver problems. COLCIN is not a painkiller and should not be used to treat pain from other causes. If you have the impression that COLCIN is too strong or too weak, you should talk to your doctor or pharmacist.

If you take more COLCIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you take more COLCIN tablets than you are supposed to (or if you think a child has accidentally swallowed any), contact your doctor or nearest hospital’s emergency department immediately. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken. At too high a dose COLCIN tablets can be very toxic, even fatal. Early symptoms of overdose include nausea, vomiting, stomach pain, bloody diarrhoea and low blood pressure.

If you forget to take COLCIN

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose to make up for forgotten individual doses.

COLCIN can have side effects. Not all side effects reported for COLCIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking COLCIN, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking COLCIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Pale red, raised, itchy bumps (hives) on the skin. These are all very serious side effects. If you have them, you may have had a serious reaction to COLCIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice the following:

• Nausea (feeling sick), vomiting (being sick), stomach pain and severe diarrhoea (see also section 2, Warnings and precautions). These may be signs of toxicity.
• Stomach pain with blood in stools and /or vomiting bright red blood. This may be due to intestinal bleeding (See Take special care with COLCIN).
• Fever, with or without chills; sores, ulcers, or white spots on the lips or in the mouth, sore throat as this can be an indication of bone marrow depression with agranulocytosis (lowered white blood cells).
• Unusual bleeding or bruising, black tarry stool, blood in urine or stools, pinpoint red spots on the skin as this can be an indication of thrombocytopenia (lowered blood platelets).
• Yellow colour of the skin and whites of the eyes, nausea, loss of appetite, fatigue, diarrhoea, swollen abdomen. These may be signs of liver problems (liver damage).
• Rhabdomyolysis (muscle breakdown). Some signs are muscle pain, muscle weakness or trouble moving arms and legs, dark red or brown urine or decreased urination. See Take special care with COLCIN.
• Pain in back and problems urinating which may be caused by kidney damage. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Less frequent side effects:
• Burning of the throat

Side effects of unknown frequency:

• Dizziness (you may have low blood pressure)
• Numbness and tingling in fingers and toes
• Burning of the skin, skin rashes, hair loss (alopecia)
• Muscle weakness (myopathy)
• Lack of fluids (dehydration)
• In men, the sperm count may temporarily be very low or may be completely absent during ejaculation
• Absence of menstruation, pain during menstruation
• A severe decrease in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia).

If you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of COLCIN.

Store all medicines out of reach of children. Store at or below 30 °C in the original packaging. Keep blisters in the carton until required for use.

Do not store in a bathroom. Do not use COLCIN after the expiry date printed on the blister strip/carton. Return all unused or expired medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).