NITRAPAM TABLETS 5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NITRAZEPAM

Boleh didapati daripada:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

NITRAZEPAM

Unit dalam pakej:

1000 Tablets

Dikeluarkan oleh:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
__________________________________________________________________________________________________________
1
NITRAPAM TABLETS 5MG
Nitrazepam (5mg)
WHAT IS IN THIS LEAFLET:
1.
What Nitrapam Tablets is used for
2.
How Nitrapam Tablets works
3.
Before you use Nitrapam Tablets
4.
How to use Nitrapam Tablets
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Nitrapam
Tablets
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT NITRAPAM TABLETS IS USED FOR
Nitrazepam is the active ingredient of
Nitrapam Tablets. It belongs to a group
of
medicines
called
benzodiazepine
which
is
widely
used
as
a
sedative/hypnotic
and
in
the
management of myoclonic seizures (fits
or convulsions with quick, involuntary
muscle jerk).
HOW NITRAPAM TABLETS WORKS
Nitrazepam works by affecting the way
certain
brain
chemicals
(neurotransmitter)
transmit
messages.
This has a calming effect which helps
you to sleep.
BEFORE YOU USE NITRAPAM TABLETS
_- When you must not use it _

If you have an eye problem called
acute
narrow
angle
glaucoma
(increased pressure in the eye).
_- Before you start to use it _
You must tell your doctor if:

you have allergies to any medicine
which you have taken previously to
treat your current condition.

You have impaired liver function.

You are pregnant, trying to become
pregnant or breast-feeding. It is
found in breast milk, use with
caution in nursing women.
-
_Taking other medicines _
Always
inform
your
doctor
and
pharmacist if you are taking any other
medicines,
including
herbal
tonics,
supplements and medicines that you buy
without prescription.

Central
nervous
system
(CNS)
depressants, other such as alcohol,
analgesics
(pain
killer),
general
anaesthetics
and
tricyclic
antidepressants
–
concurrent
use
may
increase
the
effect
of
benzodiazepines
including
Nitrapam.

Concurrent
use
of
benzodiazepine
with a narcotic analgesic, the dosage
of narcotic should be reduced by at
least one-th

Ciri produk

7039-07
NITRAPAM TABLETS 5MG
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
Each tablet contains:
Nitrazepam………………………………………………5mg
PRODUCT DESCRIPTION:
A blue, round, flat of 11mm diameter tablet with ‘MPI’ logo.
PHARMACODYNAMICS
:
Nitrazepam is a benzodiazepine hypnotic which enhances or facilitates
the inhibitory neurotransmitter action of gamma-
aminobutyric acid (GABA) receptors. It mediates both pre- and
post-synaptic inhibition in all regions in the central nervous
system, following interaction between the benzodiazepine and a
specific neuronal membrane receptor.
PHARMACOKINETICS:
Nitrazepam is 80% bioavailable after oral administration. Peak
concentrations are reached in 0.5 to 5 hours. It is widely
distributed in the body; 10 to 15% is found in cerebrospinal fluid and
85 to 90% is bound to plasma proteins. It also crosses
the placenta and is found in breast milk. It is extensively
metabolized to inactive substances that are excreted in the urine.
The elimination half-life is approximately 30 hours.
INDICATION:
Nitrazepam is a benzodiazepine widely used as a sedative/hypnotic and
in the management of myoclonic seizures.
RECOMMENDED DOSAGE:
Adults: as hypnotic the usual dose is 5 to 10mg at night
Children: dosage in children up to 12 years is not established.
ROUTE OF ADMINISTRATION:
To be taken orally.
CONTRAINDICATIONS:
It is contraindicated in patients with acute narrow angle glaucoma.
WARNINGS AND PRECAUTIONS:
1.
Abrupt drug withdrawal may result in rebound insomia, an abstinence
syndrome similar to barbiturate withdrawal
seizures or rarely, psychosis
2.
Use with caution in patient with impaired hepatic function.
3.
Nitrazepam should be used with caution in patient with chronic
obstructive lung disease or respiratory failure.
4.
This preparation may be habit forming on prolonged use.
5.
Anaphylaxis (severe allergic reaction) and angioedema (severe facial
swelling) which can occur as early as the first
time the product is taken.
6.
Complex sleep-related behaviour which may