MOTETIS Tablet Ref.[8566] Active ingredients: Tetrabenazine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Douglas Pharmaceuticals Ltd, P O Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660

Product name and form

Motetis 25 mg tablet.

Pharmaceutical Form

Yellow, round, flat tablet with a score line on one side.

Qualitative and quantitative composition

Each Motetis 25 mg tablets contains 25 mg of tetrabenazine.

Excipient(s) with known effect: Contains lactose monohydrate.

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

Motetis tablet contains iron oxide yellow, lactose monohydrate, magnesium stearate, pregelatinised maize starch and purified talc.

Pack sizes and marketing

HDPE bottle pack with child-resistant caps, containing 112 tablets.

Marketing authorization holder

Douglas Pharmaceuticals Ltd, P O Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660

Marketing authorization dates and numbers

29 November 2011

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