XENAZINE Tablet Ref.[51041] Active ingredients: Tetrabenazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Product name and form

Tetrabenazine 25 mg Tablets.

Xenazine 25.

Pharmaceutical Form

Tablet.

Yellowish-buff, circular, bevel-edged tablets with ‘CL25’ 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 tetrabenazine.

Excipient: Each tablet also contains 64 mg of lactose monohydrate.

For a 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

Maize starch
Lactose Monohydrate
Talc
Magnesium Stearate
Iron Oxide Yellow E172

Pack sizes and marketing

White HDPE bottle with a white HDPE cap. Pack size of 112 tablets.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Marketing authorization dates and numbers

PL 52637/0008

23 October 1995 / 23 October 2005

Drugs

Drug Countries
XENAZINE Estonia, France, Israel, Lithuania, Netherlands, United Kingdom, United States

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