IMOVANE TABLET 7.5 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

ZOPICLONE

Tilgængelig fra:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-kode:

N05CF01

Dosering:

7.5 mg

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

ZOPICLONE 7.5 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Opella Healthcare International SAS

Autorisation status:

ACTIVE

Autorisation dato:

1988-05-26

Indlægsseddel

IMOVANE® 7.5 MG 
Zopiclone 
film-coated scored tablets 

This package insert is continually updated: please read
carefully before using a new pack. In case 
of any question, please contact your physician or pharmacist. 
Composition 
Active ingredient: zopiclone. Each tablet contains 7.5
mg zopiclone. 
Excipients: lactose, calcium hydrogen phosphate, wheat starch,
sodium starch glycollate, 
magnesium stearate. Film coating: hypromellose, titanium dioxide
(E171), macrogol 6000. 
Properties 
Pharmacotherapeutic class: HYPNOTICS and SEDATIVES (N:
Nervous system) 
Zopiclone is a cyclopyrrolone, related to the benzodiazepine
drugs. Its 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
GABAA macromolecular complex, 
modulating the opening of the chloride ion channel. Zopiclone
reduces the time to onset of sleep 
and the frequency of nocturnal awakenings, increases the duration
of sleep and improves both the 
quality of sleep and the quality of awakening. 
In insomniac patients, zopiclone decreases stage
I, increases stage II, while preserving or 
prolonging the deep sleep stages (III and IV) and the paradoxical
sleep.  

Zopiclone is rapidly absorbed. Peak concentrations are
reached within 1.5-2 hours and they are 
approximately 60 ng/ml after administration of 7.5 mg.
Absorption is not modified by food. Plasma 
protein binding is weak (approximately 45 %) and non
saturable. After repeated administration, 
there is no accumulation of zopiclone and its
metabolites. Inter-individual variations appear to be 
low. An in vitro study indicates that cytochrome P450 (CYP) 3A4 is
the major isoenzyme involved 
in the metabolism of zopiclone. The principal metabolites are
the N-oxide derivative (active) and 
the N-demethyl metabolite (inactive). Their appa

Produktets egenskaber

SG/IMO/0822/CCDS V12 with wheat starch
IMOVANE® 7.5 MG
Zopiclone
film-coated scored tablets
This package insert is continually updated: please read carefully
before using a new pack. In case
of any question, please contact your physician or pharmacist.
COMPOSITION
Active ingredient: zopiclone. Each tablet contains 7.5 mg zopiclone.
Excipients:
lactose,
calcium
hydrogen
phosphate,
wheat
starch,
sodium
starch
glycollate,
magnesium stearate. Film coating: hypromellose, titanium dioxide
(E171), macrogol 6000.
Excipients
with
known
effect:
lactose,
wheat
starch
(containing
gluten)
(see
Warnings
and
precautions).
PROPERTIES
Pharmacotherapeutic class: HYPNOTICS and SEDATIVES (N: Nervous system)
Zopiclone is a cyclopyrrolone, related to the benzodiazepine drugs.
Its 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. Zopiclone reduces
the time to onset of sleep and
the frequency of nocturnal awakenings, increases the duration of sleep
and improves both the quality
of sleep and the quality of awakening.
In insomniac patients, zopiclone decreases stage I, increases stage
II, while preserving or prolonging
the deep sleep stages (III and IV) and the paradoxical sleep.
Zopiclone is rapidly absorbed. Peak concentrations are reached within
1.5-2 hours and they are
approximately 60 ng/ml after administration of 7.5 mg. Absorption is
not modified by food. Plasma
protein binding is weak (approximately 45 %) and non saturable. After
repeated administration, there
is no accumulation of zopiclone and its metabolites. Inter-individual
variations appear to be low. An
in vitro study indicates that cytochrome P450 (CYP) 3A4 is the major
isoenzyme involved in the
metabolism of zopiclone. The principal metabolites are the N-oxide
derivative (active) and the N-
demethyl
metabolite
(inactive).
Their
apparent
half-lives
eva