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COLCHICINA (2010)

Active ingredients: Colchicine

Product Name and Form

Colchicine 500 micrograms 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).

For excipients, see 6.1.

Chemical substance
Description
Colchicine

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
Pregelatinised Maize Starch
Stearic Acid
Purified Talc
Purified Water
Ethanol 96%

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
Authorization dates

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

23/10/2007

Marketing authorization number:

PL 29831/0055

MA 154/00301