PHARMANIAGA METRONIDAZOLE TABLET 200MG

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

METRONIDAZOLE

Dostupno od:

PHARMANIAGA MANUFACTURING BERHAD

INN (International ime):

METRONIDAZOLE

Jedinice u paketu:

1000 Tablets; 100 Tablets; 500 Tablets

Proizveden od:

PHARMANIAGA MANUFACTURING BERHAD

Uputa o lijeku

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PHARMANIAGA METRONIDAZOLE TABLET
Metronidazole (200mg, 400mg)
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 yo

Svojstava lijeka

TM
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.
ACTIONS
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.
Metronidazole is well absorbed orally with a bioavailability of at
least 80%. Peak plasma concentrations of 6, 12 and 40 mcg/mL
are achieved within 1 to 2 hours of a 250 mg, 500 mg and 2 g
single oral doses respectively. Absorption may be delayed, but is
not reduced overall by administration with food.
Metronidazole is widely distributed. It appears in most body
tissues
and
fluids
including
bile,
bone,
breast
milk,
saliva,
seminal
fluid,
liver
and
liver
abscesses,
lungs
and
vaginal
secretions. It also crosses the placenta and the blood brain
barrier. Not more than 20% is bound to plasma proteins.
Metronidazole is metabolised in the liver by side-chain oxidation
and glucuronide conjugation to 2-hydroxymethyl (also active)
and other metabolites. The half-life of metronidazole in normal
adults is 8 hours and in patients with alcoholic liver disease 18
hours.
Metronidazole and its primarily metabolites
are
rapidly removed
from the blood by haemodialysis but is not significantly removed
by peritoneal dialysis.
INDICATIONS
Metronidazole is indicated for the treatment of symptomatic
trichomoniasis in females and ma