PHARMANIAGA METRONIDAZOLE TABLET 400 MG

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

METRONIDAZOLE

Dostępny od:

PHARMANIAGA MANUFACTURING BERHAD

INN (International Nazwa):

METRONIDAZOLE

Sztuk w opakowaniu:

500 Tablets

Wyprodukowano przez:

PHARMANIAGA MANUFACTURING BERHAD

Ulotka dla pacjenta

PHARMANIAGA METRONIDAZOLE TABLET
Metronidazole (200mg, 400mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
Pharmaniaga
Metronidazole
Tablet
is
used
for
2.
How it works
3.
Before
you
use
Pharmaniaga
Metronidazole Tablet
4.
How
to
use
Pharmaniaga
Metronidazole Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Pharmaniaga
Metronidazole
Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
PHARMANIAGA
METRONIDAZOLE TABLET IS USED FOR
It is used to treat certain infections
caused
by
bacteria
and
other
organisms in different parts of the
body.
It is also used to prevent or treat
certain
infections
that
may
occur
during surgery.
HOW
PHARMANIAGA
METRONIDAZOLE TABLET
WORKS
Pharmaniaga Metronidazole Tablet
is an antibiotic that belongs to a
group
of
medicines
called
nitroimidazoles.
This medicine works by killing or
stopping the growth of bacteria and
other
organisms
causing
these
infections.
BEFORE
YOU
USE
PHARMANIAGA
METRONIDAZOLE TABLET
Inform
your
doctor
if
you
are
affected by Cockayne syndrome.
Cases of severe liver toxicity/acute
liver
failure
in
patients
with
Cockayne
syndrome
have
been
reported
with
product
containing
metronidazole.
Stop
taking
Pharmaniaga
Metronidazole Tablet and tell your
doctor immediately if you develop:
stomach pain,
decreased appetite,
nausea,
vomiting,
fever,
unusual
tiredness, yellowing of the skin &
the
whites
of
the
eyes,
dark-coloured urine, light or clay-
coloured stools or itching.
_-When you must not use it _
Do
not
use
Pharmaniaga
Metronidazole Tablet if you have
ever had an allergic reaction to:
•
Pharmaniaga
Metronidazole
Tablet
or
any
other
nitroimidazoles derivation
•
Trichomoniasis
-
Individuals
having
Sexually
Transmitted
Disease (STD)
•
Or
individuals
having
a
first
trimester of pregnancy
_Pregnancy and Lactation _
Do
not
take
Pharmaniaga
Metronidazole
Tablet
if
you
are
pregnant, trying to get pregnant or
think you may be pregnant without
discussing with you

Charakterystyka produktu

®
METRONIDAZOLE
TABLET
DESCRIPTION
_PHARMANIAGA METRONIDAZOLE TABLET 200 MG_
Yellow, round, biconvex, film-coated tablets with ‘RMB’ breakline
on one
side and plain on the other.
_PHARMANIAGA METRONIDAZOLE TABLET 400 MG_
Yellow, round, biconvex tablet with Pharmaniaga icon on one side and
plain on the other.
COMPOSITION
_PHARMANIAGA METRONIDAZOLE TABLET 200 MG_
Each film-coated tablet contains Metronidazole 200 mg.
_PHARMANIAGA METRONIDAZOLE TABLET 400 MG_
Each tablet contains Metronidazole 400 mg.
PHARMACODYNAMICS
Metronidazole is active against most obligate anaerobic bacteria and
protozoa by undergoing intracellular chemical reduction via mechanisms
unique
to
anaerobic
metabolism
within
the
organism.
Reduced
metronidazole,
which
is
cytotoxic
but
short-lived,
interacts
with
microorganisms DNA to cause a loss of helical structure, strand
breakage
and resultant inhibition of nucleic acid synthesis and cell death.
PHARMACOKINETICS
Metronidazole is rapidly absorbed from the gastro-intestinal tract.
Peak
plasma concentrations occur between 20 minutes and 3 hours. The
elimination half-life is 8.5±2.9 hours. Metronidazole can be used in
chronic renal failure; it is rapidly removed from the plasma by
dialysis.
Metronidazole is excreted in milk but the intake of a suckling infant
of a
mother receiving normal dosage would be considerably less than the
therapeutic dosage for infants.
INDICATIONS
Metronidazole is indicated for the treatment of symptomatic
trichomonia-
sis in females and males when the presence of trichomonad has been
confirmed by appropriate laboratory procedures (wet smears and/or
cultures).
Metronidazole is indicated in the treatment of asymptomatic females
when the organism is associated with endocervicitis, cervicitis or
cervical
erosion. Since there is evidence that presence of the tricomonad can
interfere with accurate assessment of abnormal cytological smears,
additional smears should be performed after eradication of the
parasite.
_T. vaginalis_ infections is a venereal disease. Therefore,
as