1. Name of the medicinal product
Colchicine 500 micrograms Tablets.
2. Qualitative and quantitative composition
Colchicine Ph Eur 535 micrograms (equivalent to Colchicine 500 micrograms on a dry weight basis).
Excipient with known effect:
One tablet contains 56.6mg of lactose
For the full list of excipients, see 6.1.
3. Pharmaceutical form
Tablet – oral use.
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of acute gout
• Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs
4.2 Posology and method of administration
Treatment of acute gout attack:
1 mg (2 tablets) to start followed by 500 micrograms (1 tablet) after 1 hour.
No further tablets should be taken for 12 hours.
After 12 hours, treatment can resume if necessary with a maximum dose of 500 micrograms (1 tablet) every 8 hours until symptoms are relieved.
The course of treatment should end when symptoms are relieved or when a total of 6 mg (12 tablets) has been taken.
No more than 6 mg (12 tablets) should be taken as a course of treatment.
After completion of a course, another course should not be started for at least 3 days (72 hours).
Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs:
500 micrograms twice daily.
The treatment duration should be decided after factors such as flare frequency, gout duration and the presence and size of tophi have been assessed.
Patients with renal impairment:
Use with caution in patients with mild renal impairment. For patients with moderate renal impairment, reduce dose or increase interval between doses. Such patients should be carefully monitored for adverse effects of colchicine (see also section 5.2).
For patients with severe renal impairment, see section 4.3.
Patients with hepatic impairment
Use with caution in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for adverse effects of colchicine.
For patients with severe hepatic impairment, see section 4.3.
Use with caution.
Method of Administration
For oral administration
Tablets should be swallowed whole with a glass of water