ZIMOVANE Film-coated tablet Ref.[7841] Active ingredients: Zopiclone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Zimovane 7.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

White, elliptical, biconvex film-coated tablets with a score-line on one side. The tablet can be divided into equal halves.

Qualitative and quantitative composition

Zopiclone 7.5 mg.

Excipient(s) with known effect:

Lactose
Wheat starch (containing gluten) (see section 4.4)

For the full list of excipients, see section 6.1.

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

Tablet Core:

Lactose monohydrate
Calcium hydrogen phosphate dihydrate
Wheat starch
Sodium starch glycollate
Magnesium stearate

Film-coating:

Hypromellose
Titanium dioxide
Macrogol 6000
Purified water
Or
Opadry OY-S-38906
Purified water

Pack sizes and marketing

PVC/aluminium foil blisters containing 56, 28, 14, 7 or 3 film-coated tablets, and in a starter pack containing 3 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as:

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0624

Date of first authorisation: 06 May 1993
Date of latest renewal: 18 March 2005

Drugs

Drug Countries
ZIMOVANE Ireland, United Kingdom

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