Colchicin Stella 1mg (2 blisters x 10 tablets/box)

Indications

For treatment of acute gout and for short-term prophylaxis during initial therapy with allopurinol and uricosuric drugs.

Contraindications

Hypersensitivity to colchicine or to any of the excipients.

Pregnant women.

Patients with renal or hepatic impairment who are talking a P-glycoprotein or a strong CYP3A4 inhibitor.

Patients undergoing haemodialysis, patients with severe renal impairment (creatinine clearance less than 10 ml/minute).

Compositon/Ingredients

Dosage and administration

Adults: 1 mg initially, followed by 0.5 mg every two to three hours until relief of pain is obtained or vomiting or diarrhoea occurs. A total dose of 6 mg should not be exceeded. The course should not be repeated within three days.

For use with allopurinol or uricosuric drugs: 0.5 mg two to three times daily.

Renal impairment: For mild/moderate renal impairment (creatinine clearance 10 – 50 ml/minute), reduce dose or increase interval between doses.

Precaution

• Colchicine should be given with care to elderly and debilitated patients; cardiac, hepatic, gastrointestinal disease.
• Avoid using Colchicine STELLA 1 mg in patients with blood disorders.
• Reduce dose in patients with mild to moderate renal impairment.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine.
• Colchicine may be used with extreme caution during breast-feeding.
• Patients should be aware of how they react to Colchicine STELLA 1 mg before driving or operating machinery.

Storage

Store at temperature below 30°C, protect from light.