Colchicine 0,5 mg Tablets

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.

Do not take COLCHICINE 0,5 mg TRINITY:

• 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 (see section 4 Possible side effects);
• 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 (see Other medicines and COLCHICINE 0,5 mg TRINITY). 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.

Do not share medicines prescribed for you with any other person. Always take COLCHICINE 0,5 mg TRINITY exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure. COLCHICINE 0,5 mg TRINITY is potentially toxic, so it is important not to exceed the dose prescribed by your doctor, pharmacist or nurse.

Adults

In acute gout the initial dose is 0,5 mg to 1 mg (i.e., 1 to 2 tablets) by mouth immediately, followed by 0,5 mg (1 tablet) every 2 hours until pain relief is obtained or gastrointestinal symptoms such as vomiting, or diarrhoea occur. A maximum total treatment course of 6 mg must not be exceeded. The course should not be repeated within 3 days, but 7 days should preferably elapse between courses of gout treatment with COLCHICINE 0,5 mg TRINITY to avoid cumulative toxicity. COLCHICINE 0,5 mg TRINITY is not a pain medication and should not be used to treat pain from other causes.

Elderly

Use with caution.

Children

COLCHICINE 0,5 mg TRINITY should not be taken by children.

Method of administration

Swallow the tablets whole with water. Your doctor, pharmacist or nurse will tell you how long your treatment with COLCHICINE 0,5 mg TRINITY will last. Treatment with COLCHICINE 0,5 mg TRINITY should not be repeated within 3 days. If you have the impression that the effect of COLCHICINE 0,5 mg TRINITY is too strong or too weak, tell your doctor, pharmacist or nurse.

If you take COLCHICINE 0,5 mg TRINITY than you should In the event of overdosage, consult your doctor, pharmacist or nurse. If neither is available, contact the nearest hospital or poison centre. If you forget to take COLCHICINE 0,5 mg TRINITY Do not take a double dose to make up for forgotten individual doses.

COLCHICINE 0,5 mg TRINITY can have side effects. Not all side effects reported for COLCHICINE 0,5 mg TRINITY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking COLCHICINE 0,5 mg TRINITY, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking COLCHICINE 0,5 mg TRINITY 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;
• Rash or itching;
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to COLCHICINE 0,5 mg TRINITY. You may need urgent medical attention.

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

• Fever;
• Sore throat or difficulty swallowing;
• Rashes or ulcers in mouth or throat;
• Skin rash or skin colourations and bruising;
• Severe nausea, vomiting or stomach pain that persist (even after treatment with COLCHICINE 0,5 mg TRINITY has been stopped);
• Unusual bleeding, bruising, tiredness or weakness, numbness or tingling.

These are all serious side effects. You may need urgent medical attention. Tell your doctor or health care provider if you notice any of the following:

• Frequent:
• Stomach pain;
• Nausea;
• Vomiting;
• Diarrhoea (runny stomach).

Frequency unknown

• 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.

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

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. 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 COLCHICINE 0,5 mg TRINITY.

Store all medicines out of sight and reach of children. Store at or below 25 ºC (room temperature). Do not take COLCHICINE 0,5 mg TRINITY after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month. Return all unused medicines to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).