Aspen Colchicine Ds Tablets

ASPEN COLCHICINE DS is used for the emergency treatment of acute gout attacks. ASPEN COLCHICINE DS is not a painkiller and should not be used to treat other causes of pain.

Do not take ASPEN COLCHICINE DS if you are:

• Hypersensitive (allergic) to colchicine or any of the other ingredients of ASPEN COLCHICINE DS (see WHAT ASPEN COLCHICINE DS CONTAINS).
• Patients with lactose intolerance should avoid this product as it contains lactose monohydrate (see WHAT ASPEN COLCHICINE DS CONTAINS).
• Pregnant.
• Undergoing haemodialysis.
• Suffering from severe kidney impairment.
• Suffering from any severe liver impairment and taking the following medicines:
  • Clarithromycin, erythromycin or telithromycin (used to treat infections).
  • Ciclosporin (used to prevent organ rejection after a transplant, psoriasis and rheumatoid arthritis).
  • Ritonavir, atazanavir or indinavir (used to treat HIV infection).
  • Ketoconazole or itraconazole (used to treat fungal infections).
  • Verapamil and diltiazem (used to treat high blood pressure or angina).
  • Quinidine (used to treat abnormal heart rhythms).
• If you have blood disorders as ASPEN COLCHICINE DS can cause a decrease in production of your red blood cells, white blood cells and blood platelets.

Take special care with ASPEN COLCHICINE DS

• If you are an elderly (≥ 65 years) or debilitated patient (a patient with impaired energy or strength) as you may be prone to the toxicity of ASPEN COLCHICINE DS. Your healthcare provider will be monitoring you for toxicity and may decide to temporarily interrupt or discontinue your treatment with ASPEN COLCHICINE DS. The first signs of toxicity are nausea, vomiting and diarrhoea.
• If you experience adverse effects in the digestive system, your doctor will decide either to withdraw ASPEN COLCHICINE DS or to reduce the dose.
• ASPEN COLCHICINE DS can cause nerve and muscle toxicity (see POSSIBLE SIDE EFFECTS). If you need to take other medicines known to cause the same effect/s e.g. ciclosporin (used in organ transplants) and HMG - CoA reductase inhibitors such as simvastatin (used to treat high cholesterol) your doctor will monitor you. If you are unsure whether you should take ASPEN COLCHICINE DS discuss it with your healthcare provider or pharmacist.

Taking/Using ASPEN COLCHICINE DS with food and drink

ASPEN COLCHICINE DS may be given at any time of the day, with or without food. Alcohol increases blood uric acid concentrations and increases the risk of digestive tract disorders.

Pregnancy and breastfeeding

You should not take ASPEN COLCHICINE DS if you are pregnant. Always tell your healthcare provider if you are taking any other medicine. If you are pregnant or breastfeeding, please consult your healthcare provider for advice before taking ASPEN COLCHICINE DS.

Always take ASPEN COLCHICINE DS exactly as your healthcare provider has instructed you. You should check with your doctor or pharmacist if you are unsure. Do not share medicines prescribed for you with any other person.

Dosage

Your healthcare provider will decide on the appropriate dose for you, based on your condition.

Acute attacks of gout in adult patients: Take 1 mg (one tablet) immediately, followed by 0,5 mg (half a tablet) 2 hourly until pain is relieved or until vomiting or diarrhoea occur. A maximum dosage of 6 mg (six tablets) must not be exceeded. A minimum of 3 days, but preferably 7 days, should elapse between courses of gout treatment with ASPEN COLCHICINE DS to avoid cumulative toxicity. If you have severe kidney problems, you should not take ASPEN COLCHICINE DS. ASPEN COLCHICINE DS is not an analgesic medication and should not be used to treat pain from other causes. If you have the impression that the effect of ASPEN COLCHICINE DS is too strong or too weak, tell your doctor or pharmacist.

If you take more ASPEN COLCHICINE DS than you should

Fatal overdoses have been reported with ASPEN COLCHICINE DS in adults and children. In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, go to the nearest hospital or poison control centre.

If you forget to take ASPEN COLCHICINE DS

Take your missed dose as soon as you remember if within a few hours after missing a dose. Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking ASPEN COLCHICINE DS 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 on the skin. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ASPEN COLCHICINE DS. 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 any of the following:

• Diarrhoea, nausea, vomiting and stomach pain as this can be signs of toxicity.
• Abnormal urine colour (dark, red, or cola coloured), decreased urine production, general weakness, muscle stiffness or aching, muscle tenderness, weakness of the affected muscles as this can be an indication of rhabdomyolysis (see Take special care with ASPEN COLCHICINE DS).
• 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 tiredness or weakness, headache, difficulty in breathing (usually associated with increased physical activity).
• 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).
• Vomiting and/or diarrhoea, nausea, weight loss, nocturnal urination (night time urination), more frequent urination as these may be signs of renal problems (renal damage).
• Nausea, loss of appetite, fatigue, diarrhoea, swollen abdomen, yellow colour of the skin and whites of the eyes as these may be signs of liver problems (liver damage). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been frequently reported:

• Hair loss.

The following side effects have been reported less frequently:

• Mild numbness in fingers and toes.
• Burning of the throat.
• Muscle weakness.
• Inhibition of sperm production.

The following side effects have been reported, but the frequency is unknown:

• Low blood pressure.

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

Store at or below 25 °C. Protect from light. Keep the blisters in the outer carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.