INSOPIN 7.5MG TABLET

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

ZOPICLONE

Beschikbaar vanaf:

DUOPHARMA (M) SDN. BHD.

INN (Algemene Internationale Benaming):

ZOPICLONE

Eenheden in pakket:

100 Tablet Tablets

Geproduceerd door:

DUOPHARMA (M) SDN. BHD.

Bijsluiter

_CONSUMER MEDICATION _
_INFORMATION_
_ LEAFLET (RIMUP) _
INSOPIN TABLET
Zopiclone (7.5 mg)
CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCC
1
WHAT IS IN THIS LEAFLET
1.
What
INSOPIN
TABLET
is used for
2.
How
INSOPIN
TABLET
works
3.
Before
you
use
INSOPIN
TABLET
4.
How
to
use
INSOPIN
TABLET
5.
While
you
are
using
INSOPIN TABLET
6.
Side effects
7.
Storage
and
disposal
of
INSOPIN TABLET
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT INSOPIN TABLET IS
USED FOR
INSOPIN TABLET is used in
for short treatment of sleeping
difficulties (insomnia) (2 to 4
weeks).
HOW
INSOPIN
TABLET
WORKS
INSOPIN
TABLET
contains
Zopiclone
which
is
a
short-
acting hypnotic which work by
acting
on
the
brain
to
cause
sleepiness.
Zopiclone
helps
you fall asleep and reduces the
number of times you wake up
during the night.
BEFORE
YOU
USE
INSOPIN
TABLET
_-_
_ _
_When you must not use it _
Do not use INSOPIN TABLET
if you:

allergic to Zopiclone or any
of
the
other
ingredients
listed
at
the
end
of
the
leaflet.

suffer from severe muscle
weakness

have
severe
breathing
problems

suffer
from
breathing
problems whilst sleeping

have stroke
_-_
_ _
_Before you start to use it _
Before
taking
INSOPIN
TABLET, you must tell your
doctor
or
pharmacist
if
you
have, or have had, any of the
following conditions:

Long
term
breathing
problems

Impaired
thyroid
hormone
or hormone imbalance

Depression

Had history of seizure

Prone to drug abuse
INSOPIN TABLET is not to
be used in children.
_Pregnancy _
ASK FOR YOUR DOCTOR’S ADVICE
IF YOU ARE PREGNANT, OR LIKELY
TO
BECOME
PREGNANT
DURING
YOUR COURSE OF MEDICATION.
_Breastfeeding _
ASK FOR YOUR DOCTOR’S ADVICE
IF YOU ARE BREASTFEEDING, OR
LIKELY
TO
BREASTFEED
DURING
YOUR COURSE OF MEDICATION.
INSOPIN
TABLET
IS
SECRETED
IN
BREAST
MILK
THEREFORE
USE
IN
NURSING
MOTHER IS NOT RECOMMENDED.
_-_
_ _
_Taking other medicines _
Inform
your
doctor
or
pharmacist
before
taking
INSOPIN TABLET.
Before
using
INSOPIN
TA

Productkenmerken

[DUOPHARMA (M) SDN BHD]
[Page 1/2]
[Revision Date: 30.10.2020]
INSOPIN 7.5MG TABLET
DESCRIPTION: A yellow oval shaped tablet, scored on one side with
marking '861' and marking 'DUO' on the other side.
COMPOSITION: Each tablet contains Zopiclone BP 7.5 mg
PHARMACODYNAMICS: Zopiclone, a cyclopyrrolone derivative, is a
short-acting hypnotic agent. Zopiclone belongs to a novel chemical
class which is
structurally unrelated to existing hypnotics. The pharmacological
profile of zopiclone is similar to that of the benzodiazepines.
PHARMACOLOGY: In sleep laboratory studies of 1 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 zopiclone on
stage 3 and 4 sleep differs from that of the benzodiazepines which
suppress slow wave
sleep. The clinical significance of this finding is not known.
PHARMACOKINETICS:
ABSORPTION, DISTRIBUTION AND BIOAVAILABILITY: Zopiclone is rapidly
absorbed and distributed after oral administration, the time of
maximum observed plasma
concentration being about 1.75 hours. A study of 16 healthy volunteers
receiving a single dose of 7.5 mg of zopiclone intravenously
demonstrated the apparent
volume of distribution of zopiclone to be 104 ± 15.5 L.
Autoradiographic studies in the rat showed rapid distribution into the
blood and peak tissue levels at 0.5 hours in the liver, small
intestines, stomach, kidneys and
the adrenals. After twenty four hours the total residual radioactivity
in the body of the rat was 8%.
The bioavailability of the 7.5 mg tablets in man is 76.3 ± 9.6%, a
hepatic first pass effect has been demonstrated.
In fresh human plasma, zopiclone is approximately 45% prote