IMOVANE Tablet Ref.[51093] Active ingredients: Zopiclone

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2020  Publisher: sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa

Product name and form

IMOVANE TABLETS.

Pharmaceutical Form

White, film-coated, elliptical tablets, with a breakline on one side.

Qualitative and quantitative composition

Each tablet contains: Zopiclone 7,5 mg.

Other excipients are: Calcium hydrogen phosphate, lactose, magnesium stearate, sodium starch glycolate, wheat starch and the film-coating contains: hypromellose, macrogol 6000 and titanium dioxide.

Contains sugar (lactose): IMOVANE contains 31,6 mg lactose per tablet.

Active Ingredient Description
Zopiclone

Zopiclone is a hypnotic agent belonging to the cyclopyrrolone class of psychotherapeutic agents. It rapidly initiates and sustains sleep without reduction of total REM sleep and with preservation of slow wave sleep. Negligible residual effects are seen the following morning. Its pharmacological properties include hypnotic, sedative, anxiolytic, anticonvulsant and muscle-relaxant actions.

List of Excipients

Calcium hydrogen phosphate
Lactose
Magnesium stearate
Sodium starch glycolate
Wheat starch

Film-coating contains:

Hypromellose
Macrogol 6000
Titanium dioxide

Pack sizes and marketing

Blister packs of 30 tablets.

Marketing authorization holder

sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa

Marketing authorization dates and numbers

T/2.2/104

Date of registration: 15 July 1988

Drugs

Drug Countries
IMOVANE Australia, Brazil, Canada, Estonia, Finland, France, Hong Kong, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, South Africa

© 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.