COLCHICINE Tablet Ref.[6748] Active ingredients: Colchicine

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Tiofarma B.V., Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, Netherlands

Product name and form

Colchicine Tiofarma 500 microgram tablets

Pharmaceutical Form
Tablet. Off-white, round, flat tablets with facet, ca. 6 mm diameter, ca. 3 mm thickness and with the inscription “0,5” on one side.

Qualitative and quantitative composition

Each Colchicine Tiofarma 500 microgram Tablet contains 500 micrograms of colchicine.

Each Colchicine Tiofarma 500 microgram Tablet contains 83 mg of the excipient lactose monohydrate, equivalent to 78.6 mg of lactose anhydrous.

Each Colchicine Tiofarma 500 microgram Tablet contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

Active Ingredient	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
Microcrystalline cellulose E460 Lactose monohydrate Sodium starch glycolate Magnesium stearate E572

Pack sizes and marketing

Colchicine Tiofarma 500 microgram Tablets are available in:

Blisters:

12 tablets in a PVC/Alu blister, with 12 tablets in a carton box
10 tablets in a PVC/Alu blister, with 30 or 100 tablets in a carton box.

Containers:

250 tablets in a polypropylene container with closure in a carton box.

Not all pack sizes may be marketed.

Marketing authorization holder

Tiofarma B.V., Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, Netherlands

Marketing authorization dates and numbers

PA2200/001/001

Date of first authorisation: 29^th September 2017
Date of last renewal: 15^th August 2022

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