JAMP-ZOPICLONE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ZOPICLONE

Saatavilla:

JAMP PHARMA CORPORATION

ATC-koodi:

N05CF01

INN (Kansainvälinen yleisnimi):

ZOPICLONE

Annos:

7.5MG

Lääkemuoto:

TABLET

Koostumus:

ZOPICLONE 7.5MG

Antoreitti:

ORAL

Kpl paketissa:

30/100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0122562001; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2022-09-07

Valmisteyhteenveto

Page 1 of 37
PRODUCT MONOGRAPH
PR
JAMP-ZOPICLONE
ZOPICLONE TABLETS, HOUSE STANDARD
3.75 MG
PR
JAMP-ZOPICLONE TABLETS
ZOPICLONE TABLETS, HOUSE STANDARD
5 MG AND 7.5 MG
Hypnotic and Sedative
JAMP Pharma Corporation
Date of Revision:
1310 rue Nobel,
September 18, 2019
Boucherville, Quebec
J4B 5H3
Control # 231494
Page 2 of 37
NAME OF DRUG
JAMP-ZOPICLONE
Zopiclone Tablets, 3.75 mg,
JAMP-ZOPICLONE TABLETS
Zopiclone Tablets, 5 mg and 7.5 mg
Hypnotic and Sedative
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of zopiclone and opioids may result in profound
sedation, respiratory depression,
coma, and death (see WARNINGS, Risks from concomitant use of opioids
and benzodiazepines
or other CNS depressants).

Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.

Limit dosages and duration to the minimum required.

Follow patients for signs and symptoms of respiratory depression and
sedation.
ACTIONS, CLINICAL PHARMACOLOGY
Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic
agent. Zopiclone is structurally
unrelated to existing hypnotics. However, the pharmacological profile
of zopiclone is similar to
that of the benzodiazepines.
Zopiclone pharmacological properties are: hypnotic, sedative,
anxiolytic, anti-convulsant, muscle-
relaxant. These effects are related to a specific agonist action at
central receptors belonging to the
GABA
a
macromolecular complex, modulating the opening of the chloride ion
channel.
In sleep laboratory studies of one to 21-day duration in man,
zopiclone reduced sleep latency,
increased the duration of sleep and decreased the number of nocturnal
awakenings. Zopiclone
delayed the onset of REM sleep but did not reduce consistently the
total duration of REM periods.
The duration of stage 1 sleep was shortened, and the time spent in
stage 2 sleep increased. In most
studies, stage 3 and 4 sleep tended to be increased, but no change and
actual decreases have also
been observed. The effect of zopic