ZOPIVANE Film-coated tablet Ref.[115177] Active ingredients: Zopiclone

Source: Health Products Regulatory Authority (ZA)  Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530

Product name and form

ZOPIVANE (7,5 mg film-coated tablets).

Pharmaceutical Form

Film-coated tablets.

White, film coated, oblong-shaped, shallow convex tablets with central breakline on one side and plain on the other side.

Qualitative and quantitative composition

Each tablet contains zopiclone 7,5 mg.

Contains sugar: lactose monohydrate 40,000 mg per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient

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

Tablet core:

Colloidal silicon dioxide (Aerosil 200)
Lactose monohydrate
Magnesium stearate
Maize starch
Sodium starch glycolate

Tablet coating:

Opadry QX321A180025

Opadry QX321A180025:

Glycerol monocaprylocaprate
Macrogol (PEG) Polyvinyl alcohol graft copolymer
Polyvinyl alcohol
Talc
Titanium dioxide

Pack sizes and marketing

ZOPIVANE tablets are supplied in blister strips of 10 tablets, packed in 30’s in a carton.

Marketing authorization holder

CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530

Marketing authorization dates and numbers

35/2.2/0021

10 January 2023

Drugs

Drug Countries
ZOPIVANE Hong Kong, South Africa

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