AXCEL METRONIDAZOLE-200 TABLET

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

METRONIDAZOLE

Dostupno od:

KOTRA PHARMA (M) SDN. BHD.

INN (International ime):

METRONIDAZOLE

Jedinice u paketu:

100 Tablets; 1000 Tablets

Proizveden od:

KOTRA PHARMA (M) SDN. BHD.

Uputa o lijeku

AXCEL METRONIDAZOLE TABLET
Metronidazole (200mg, 400mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Axcel Metronidazole
Tablet is used for.
2.
How Axcel Metronidazole
Tablet works.
3.
Before you use Axcel
Metronidazole Tablet.
4.
How to take Axcel
Metronidazole Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage and disposal of Axcel
Metronidazole Tablet.
8.
Product description.
9.
Manufacturer and Product
Registration Holder.
10.
Date of revision.
WHAT AXCEL METRONIDAZOLE TABLET
IS USED FOR
Axcel Metronidazole Tablet is used
to treat certain infections caused by
bacteria
and
other
organisms
in
different parts of the body.
HOW
AXCEL
METRONIDAZOLE
TABLET
WORKS
Axcel
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
AXCEL
METRONIDAZOLE TABLET

_When you must not use it_

Do
not
take
Axcel
Metronidazole
Tablet
if
you
have
ever
had
an
allergic reaction to:

Metronidazole or any other
nitroimidazoles.



Any of the ingredients listed at
the end of this leaflet

Do not take Axcel Metronidazole
Tablet if:

You have or have had a blood
disorder



You have or have had a disease
of
the
brain,
spinal
cord
or
nerves.


_Before you start to use it_

You must tell your doctor if you have
any allergies to any other medicines
or any other substances such as
foods, preservatives or dyes.
Tell your doctor if you have or have
ever
had
any
health
problems/
medical conditions including:

A blood disorder.


Disease of the brain, spinal cord
or nerves


You drink alcohol


taking any medicine.
_ _
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
Axcel
Metronidazole
Tablet
and
tell
yo

Svojstava lijeka

central nervous system should be used with great care of
metronidazole. All patients receiving metronidazole for more
than
10
days
should
be
monitored
and
treatment
discontinued if signs of peripheral neuropathy or CNS toxicity
develop.
Cases
of
severe
hepatotoxicity
/
acute
hepatic
failure,
including cases with a fatal outcome with very rapid onset
after treatment initiation in patients with Cockayne syndrome
have been reported with products containing metronidazole
for systemic use. In this population, metronidazole should
therefore be used after careful benefit-risk assessment and
only if no alternative treatment is available. Liver function
tests must be performed just prior to the start of therapy,
throughout and after end of treatment until liver function is
within ranges, or until the baselines values are reached. If
the liver function test become markedly elevated during
treatment, the drug should be discontinued.
Patients with Cockayne syndrome should be advised to
immediately report any symptoms of potential liver injury to
their physician and stop taking metronidazole.
_Use in Pregnancy and Lactation:_
Use of metronidazole should be avoided during pregnancy,
especially
the
first
trimester
and
especially
high
dose
regimens. Women taking metronidazole should not breast
feed their babies.
SIDE EFFECTS:
Gastrointestinal discomfort, in particular anorexia, nausea,
diarrhoea,
epigastric
distress
and
abdominal
cramping,
headache, vomiting, coated tongue, glossitis, stomatitis,
dryness of the mouth and unpleasant taste; skin rashes, and
less frequently, vertigo, depression, insomia, drowsiness,
urethral discomfort and darkening of the urine. Incoordination
and ataxia are rare. Occasionally, numbness or paresthesia
of
an
extremity
and
a
temporary
decrease
in
the
total
white-cell
count
may
occur.
Urticaria,
flushing,
pruritus,
dysuria, cystitis, a sense of pelvic pressure, and dryness of
the
vagina
or
vulva
have
been
reported
following
administration
of
the
drug.
In
some
individuals
the
consumption of alcohol wi