ANPRO-ZOLPIDEM TABLETS 10 MG

Страна: Малайзия

Език: английски

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

Активна съставка:

ZOLPIDEM TARTRATE

Предлага се от:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Международно Name):

ZOLPIDEM TARTRATE

Броя в опаковка:

1000Tablet Tablets; 100Tablet Tablets

Произведено от:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Листовка

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ANPRO-ZOLPIDEM TABLETS 10MG
Zolpidem Tartrate (10mg)
WHAT IS IN THIS LEAFLET
1.
What Anpro-Zolpidem Tablets
10mg is used for
2.
How Anpro-Zolpidem Tablets
10mg works
3.
Before
you
take
Anpro-
Zolpidem Tablets 10mg
4.
How to take Anpro-Zolpidem
Tablets 10mg
5.
While you are taking Anpro-
Zolpidem Tablets 10mg
6.
Side Effects
7.
Storage
and
Disposal
of
Anpro-Zolpidem Tablets 10mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ANPRO-ZOLPIDEM TABLETS
10MG IS USED FOR
It is indicated in the treatment of
sleep
disorders
in
occasional
insomnia (difficulty falling and/ or
staying
sleep)
and
transient
(impermanent) insomnia.
HOW ANPRO-ZOLPIDEM TABLETS
10MG WORKS?
Zolpidem
Tartrate
is
the
active
ingredient
of
Anpro-Zolpidem
Tablets
10mg.
It
has
similar
sedative
properties
to
benzodiazepine medicines.
Zolpidem
Tartrate
belongs
to
a
group
of
medicines
called
imidazopyridine
hypnotics.
It
works by acting on your brain to
help you sleep.
BEFORE YOU TAKE ANPRO-ZOLPIDEM
TABLETS 10MG
_-When you must not take it _

If
you
are
allergic
(hypersensitive)
to
Zolpidem
Tartrate
or
any
other
ingredients of Anpro-Zolpidem
Tablets
10mg
in
the
formulation.

If you have acute and/or severe
breathing problems.

If you have severe, acute or
chronic liver problem because
of the risk of encephalopathy
(disorder
or
disease
of
the
brain).

If you have sleep apnea (stop
breathing for short periods at
night).

If
you
have
severe
muscle
weakness problem (myasthenia
gravis).
-
_Before you start to take it _
You must tell your doctor if:

You
have
allergies
to
any
medicine
which
you
have
taken previously to treat your
current condition.

You
are
pregnant,
trying
to
conceive or breast-feeding.

You are dependent on alcohol
or other medicines.

You have insomnia.

You are suffering from major
depression.

You
are
elderly
or
suffering
from
kidney
or
liver
impairment, which exposed to
accumulation risk upon taking
Zolpidem

Данни за продукта

7179-03
ANPRO-ZOLPIDEM TABLETS 10MG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
Each tablet contains:
Zolpidem
Tartrate………………………………………………10mg
PRODUCT DESCRIPTION:
A yellow, oblong tablet of size 10 x 4mm.
PHARMACODYNAMICS:
Pharmacologically, zolpidem binds selectively to the omega-1 subclass
(or BZ1) of benzodiazepine receptors in the
brain without binding to peripheral benzodiazepine receptors. This has
been corroborated by the observation that
zolpidem has little or no muscle relaxant properties.
Zolpidem has been shown to reduce sleep latency (time to fall asleep),
decrease the number of awakenings, and to
increase total sleep time. While REM sleep is not significantly
decreased, the onset of REM is delayed. The
REM/non-REM ratio is not significantly altered. Slow wave (stage 3 and
4) sleep time is increased. This more
closely resembles natural sleep than does hypnosis induced by the
benzodiazepines; this may result in fewer
adverse reactions related to disturbance of normal sleep patterns.
PHARMACOKINETICS:
_Absorption _
Zolpidem is rapidly absorbed from the gastrointestinal tract after
oral doses, peak plasma concentrations occuring
within 3 hours.
Bioavailability, Oral, tablets: 70%
Effect of food : decreased systemic exposure (decreased Cmax and AUC;
increased Tmax)
_Distribution _
Zolpidem is about 92% bound to plasma proteins.
The distribution volume in adults is 0.54L/kg.
Zolpidem is distributed into breast milk.
_Metabolism _
Liver, extensive
Zolpidem undergoes first-pass metabolism. It is metabolised mainly by
the cytochrome P450 isoenzyme CYP3A4;
_Elimination _
Zolpidem has an elimination half-life of about 2.5 hours. The inactive
metabolites of zolpidem are excreted in the
urine and faeces.
Zolpidem is not dialysable.
_Populations at risk _

In patients with renal insufficiency, whether dialysed or not, a
moderate decrease in clearance is observed.
Other kinetic parameters remain unchanged.

In patients with hepatic insufficiency, the bioavailability of
zolpi