TORZOLP Tablets 10mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ZOLPIDEM TARTRATE

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ZOLPIDEM TARTRATE

Unit dalam pakej:

100tablet Tablets; 30 Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD

Risalah maklumat

TORZOLP TABLETS
_ _
Zolpidem Tartrate (10mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Torzolp used for.
2.
How Torzolp works.
3.
Before you use Torzolp.
4.
How to use Torzolp.
5.
While you are using it.
6.
Side effects.
7.
Storage and Disposal of Torzolp.
8.
Product Description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
11.
Serial Number
WHAT TORZOLP IS USED FOR
Torzolp
is
used
for
temporary
sleep
problems that are causing you severe
distress
or
that
are
affecting
your
everyday
life.
This
includes
sleep
problems such as:
•
Difficulty falling asleep.
•
Waking in the middle of the night.
•
Waking too early.
HOW TORZOLP WORKS
Torzolp
contains
a
medicine
called
zolpidem
tartrate.
This
belongs
to
a
group of medicines called hypnotics. It
works by acting on your brain to help
you sleep.
BEFORE YOU USE TORZOLP
-
_When you must not use it _
Do not take Torzolp:
•
If you are allergic (hypersensitive)
to zolpidem tartrate or any of the
other ingredients of Torzolp.
•
Signs
of
an
allergic
reaction
include:
a
rash,
swallowing
or
breathing
problems,
swelling
of
your lips, face, throat or tongue
Do not take this medicine if any of the
above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking Torzolp.
_Pregnancy and lactation_
Do not take Torzolp if you are pregnant
or plan to become pregnant or think you
might be pregnant.
Do not take Torzolp if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
Check with your doctor or pharmacist
before taking your medicine if:
•
You have a history of alcohol or
drug abuse.
•
You have liver problems.
•
You have depression or have had
another mental illnesses in the past.
•
You have recently taken Torzolp or
other similar medicines for more
than four weeks.
•
You are elderly.
If you are not sure if any of the above
applies to you, talk to your doctor or
pharmacist before taking Torzo

Ciri produk

For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
ART WORK SIZE
:
DATE
:
Reviewed By
NO. OF COLORS: 1
COUNTRY : Malaysia
Front-Back
Torzolp
Insert
S/S
150 x 240
xxxxxxxxxx-5253
xxxxxxxx-5253
Black
18-03-2020
PANTONE SHADE NOS.:
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
Indrad
QUALITY
Approved By
COMPOSITION
Each film coated tablet contains
Zolpidem Tartrate U.S.P. 10 mg
Excipients q.s.
Colour: Ferric oxide red, Ferric oxide yellow and Titanium dioxide
DESCRIPTION
Yellow
coloured,
capsule
shaped
tablets
with
‘Torrent
logo’
debossing on one side and ‘10 MG’ debossing on another side.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS:
Subunit
modulation
of
the
GABA
A
receptor
chloride
channel
macromolecular complex is hypothesized to be responsible for
sedative,
anticonvulsant,
anxiolytic,
and
myorelaxant
drug
properties.
The
major
modulatory
site
of
the
GABA
A
receptor
complex is located on its alpha (
α
) subunit and is referred to as the
benzodiazepine (BZ) or omega (
ω
) receptor. At least three subtypes
of the (
ω
) receptor have been identified.
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent
with a chemical structure unrelated to benzodiazepines, barbiturates,
pyrrolopyrazines, pyrazolopyrimidines or other drugs with known
hypnotic properties, it interacts with a GABA-BZ receptor complex
and
shares
some
of
the
pharmacological
properties
of
the
benzodiazepines.
In
contrast
to
the
benzodiazepines,
which
non-selectively
bind
to
and
activate
all
BZ
receptor
subtypes,
zolpidem _in vitro_ binds the (BZ
1
) receptor preferentially with a high
affinity ratio of the alpha
1
/alpha
5
subunits. The (BZ
1
) receptor is
found primarily on the Lamina IV of the sensorimotor cortical regions,
substantia
nigra
(pars
reticulata),
cerebellum
molecular
layer,
olfactory bulb, ventral thalamic complex, pons, inferior colliculus,
and
globus pallidus. This selective binding of