PURI-NETHOL Tablet Ref.[49828] Active ingredients: Mercaptopurine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Puri-Nethol 50 mg Tablets.

Pharmaceutical Form

Tablet.

Pale yellow, round tablets, biconvex, scored on one side, engraved PT and 50 on either side of the scoreline and plain on the other side.

The scoreline is only to facilitate breaking of the tablets for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 50 mg of the active substance mercaptopurine monohydrate.

Excipients with known effect: Each tablet contains 59mg of the excipient lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mercaptopurine

Mercaptopurine is an inactive pro-drug which acts as a purine antagonist but requires cellular uptake and intracellular anabolism to thioguanine nucleotides for cytotoxicity. The mercaptopurine metabolites inhibit de novo purine synthesis and purine nucleotide interconversions. The thioguanine nucleotides are also incorporated into nucleic acids and this contributes to the cytotoxic effects of the active substance.

List of Excipients

Lactose monohydrate
Maize starch
Modified maize starch
Stearic acid
Magnesium stearate

Pack sizes and marketing

Amber glass bottle containing 25 tablets with a child resistant high density polyethylene/polypropylene closure with induction heat seal liners (IHS).

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA1691/009/001

Date of first authorisation: 1st April 1979
Date of last renewal: 1st April 2009

Drugs

Drug Countries
PURI-NETHOL Austria, Estonia, Hong Kong, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Romania

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.