NEGATIL TABLET 200MG

Riik: Malaisia

keel: inglise

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

Toimeaine:

SULPIRIDE

Saadav alates:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Rahvusvaheline Nimetus):

SULPIRIDE

Ühikuid pakis:

500 Tablet Tablets; 500 Tablets

Valmistatud:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
NEGATIL TABLET
Sulpiride (50mg, 200mg)
WHAT IS IN THIS LEAFLET
1.
What Negatil Tablet is used for
2.
How Negatil Tablet works
3.
Before you use Negatil Tablet
4.
How to use Negatil Tablet
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Negatil
Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT NEGATIL TABLET IS USED FOR
It
is
indicated
for
the
treatment
of
schizophrenia (a severe brain disorder in
which
people
interprets
reality
abnormally) and also chronic delusional
psychoses (a brain disorder which results
in confusion and
misinterpretations of
reality).
HOW NEGATIL TABLET WORKS
Sulpiride
is
the
active
ingredient
of
Negatil Tablet. Sulpiride belongs to a
group of medicines call benzamide. It
works by blocking effect of a natural
chemical
in
the
brain
known
to
be
involved
in
regulating
mood
and
behavior, amongst other things.
BEFORE YOU USE NEGATIL TABLET
-
_When you must not use it _
If you have:

pre-existing
central
nervous
system depression (suppression
of brain activity that can result
in decreased rate of breathing,
heart
rate,
and
loss
of
consciousness) or coma,

bone-marrow
suppression
or
phaeochromocytoma (tumor on
the adrenal gland),

severe
liver,
kidney
or
blood
disease and breast-feeding.

hypersensitivity
(allergic)
to
sulpiride or its ingredient.
-
_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
are
pregnant,
trying
to
become
pregnant
or
breast-
feeding.

If
you
have
impaired
liver,
kidney,
cardiovascular
(heart
and
blood
vessels),
cerebrovascular
(brain
and
its
blood vessels) and respiratory
(breathing) function.

If
you
have
the
following
conditions:

closed-angle
glaucoma
(eye
condition
caused
by
too
much
fluid
pressure
inside the eye),

parkinsonism
(progressive
disorder
of
the
nervous
system
that
affects
movement),

di

Toote omadused

7097-07
NEGATIL TABLET 50MG
NEGATIL TABLET 200MG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
NEGATIL TABLET 50MG
Each tablet contains:
Sulpiride
…………………………………………………50mg
NEGATIL TABLET 200MG
Each tablet contains:
Sulpiride…………………………………………………200mg
PRODUCT DESCRIPTION:
NEGATIL TABLET 50MG
A yellow, round, scored of diameter 7mm flat tablet with ‘MPI’
marking.
NEGATIL TABLET 200MG
An orange, round, scored of diameter 9mm convex tablet with ‘MPI’
marking.
PHARMACODYNAMICS
:
Sulpiride is a substituted benzamide which is claimed to exert its
antipsychotic action via a selective blockage of central dopamine
D2 receptors.
PHARMACOKINETICS:
Sulpiride is absorbed from the gastro-intestinal tract although
bioavailability is low and subject to interindividual variation. It is
rapidly distributed to the tissues but passage across the blood brain
barrier is poor. Sulpiride is less than 40% bound to plasma
proteins and is reported to have plasma half-life of about 7 to 9
hours. It is excreted in the urine chiefly as unchanged drug.
INDICATION:
Sulpiride is indicated for the treatment of schizophrenia and also
chronic delusional psychoses.
RECOMMENDED DOSAGE:
Adult: Initial doses of 200-400mg twice daily, increased if necessary
up to a maximum of 1-2g twice daily. Doses at the lower end
of the range have a greater alerting effect and have been recommended
for patients with predominant negative symptoms.
Children: 3-5mg per kg body-weight.
Children under 14 years not recommended.
Elderly: Initiallly quarter to half adult dose.
ROUTE OF ADMINISTRATION:
Oral
CONTRAINDICATIONS:
Contraindicated
in
patients
with
pre-existing
central
nervous
system
depression
or
coma,
bone-marrow
suppression,
or
phaeochromocytoma, severe hepatic, renal or blood disease and
breast-feeding.
WARNINGS AND PRECAUTIONS:
1.
It may cause sedative effects and is most marked during the first few
days of adminstration; affected patients should not drive
or operate machinery.
2.
Caut