NEOMERCAZOLE Tablet Ref.[49851] Active ingredients: Carbimazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Product name and form

NeoMercazole 5 mg Tablets.

Pharmaceutical Form

Tablet.

Pink, circular biconvex tablet, imprinted with “Neo 5” on the obverse and plain on the reverse.

Qualitative and quantitative composition

Each NeoMercazole 5 mg tablet contains carbimazole 5 mg.

Excipients with known effect:

Lactose monohydrate (30.0 mg/tablet)
Sucrose (139.39 mg/tablet)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Carbimazole

Carbimazole, a thionamide, is a pro-drug which undergoes rapid and virtually complete metabolism to the active metabolite, thiamazole, also known as methimazole. The method of action is believed to be inhibition of the organification of iodide and the coupling of iodothyronine residues which in turn suppress the synthesis of thyroid hormones.

List of Excipients

Lactose monohydrate
Starch maize
Gelatin
Magnesium stearate
Sucrose
Acacia
Talc
Red Iron oxide E172

Pack sizes and marketing

NeoMercazole 5 mg tablets are available in HDPE bottles with polypropylene tamper-evident screw cap with integrated desiccant. Each bottle contains 100 tablets.

Marketing authorization holder

Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Marketing authorization dates and numbers

PA1142/002/001

Date of first authorisation: 13 March 1995
Date of last renewal: 13 March 2010

Drugs

Drug Countries
NEO-MERCAZOLE Australia, France, Ireland, New Zealand

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