NITOMAN Tablet Ref.[27767] Active ingredients: Tetrabenazine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Nitoman 25 mg Tablets.

Pharmaceutical Form

Tablet.

Yellowish-buff, circular, bevel-edged tablets having ‘CL25’ imprinted on one face and a single scoreline on the other.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 25 mg of Tetrabenazine.

Excipients: Contains Lactose Monohydrate 64 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tetrabenazine

Tetrabenazine is a synthetic derivative of benzylquinolizine that causes depletion of dopamine and other monoamines in the central nervous system. The precise mechanism by which tetrabenazine exerts its effects is unknown, but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. Neurotransmitter depletion by a single dose of tetrabenazine is reversible and lasts only a few hours.

List of Excipients

Lactose monohydrate
Maize starch
Talc
Magnesium stearate
Iron oxide yellow, (E172)

Pack sizes and marketing

A white HDPE bottle containing 112 tablets with a white HDPE cap.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA2280/003/001

Date of first authorisation: 1 April 1994
Date of last renewal: 1 April 2009

Drugs

Drug Countries
NITOMAN Canada, Spain, Ireland

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