Active ingredients: Colchicine

Product name and form

Colchicine 500 microgram Tablets.

Pharmaceutical Form

Tablet – oral use.

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 section 6.1.

Active Ingredient

Colchicine is considered to act against the inflammatory response to urate crystals, by possibly inhibiting the migration of granulocytes into the inflamed area. Other properties of colchicine, such as interaction with the microtubules, could also contribute to the operation. Onset of action is approximately 12 hours after oral administration and is maximal after 1 to 2 days.

List of Excipients

Lactose monohydrate
Microcrystalline cellulose
Pregelatinised starch
Sodium starch glycolate
Magnesium stearate

Pack sizes and marketing

Polypropylene or polyethylene containers containing 100 or 500 tablets. Strip packs of opaque white or clear PVC film and 20ยต aluminium foil of 10 or 14 tablets.

The tablets will be packed in multiple strips of 10 tablets ie 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 tablets.

The tablets will be packed in multiple strips of 14 tablets ie 14, 28, 56, 84 or 112 tablets.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom

Marketing authorization dates and numbers

PL 29831/0055