Axcel CIPROFLOXACIN-500MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE

Available from:

KOTRA PHARMA (M) SDN. BHD.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Units in package:

10 x 10'stablet Tablets

Manufactured by:

KOTRA PHARMA (M) SDN. BHD.

Patient Information leaflet

AXCEL CIPROFLOXACIN TABLET
_Ciprofloxacin Hydrochloride (250mg & 500mg) _
_ _
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Axcel Ciprofloxacin Tablet
is used for.
2.
How Axcel Ciprofloxacin Tablet
works.
3.
Before
you
use
Axcel
Ciprofloxacin Tablet.
4.
How to use Axcel Ciprofloxacin
Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Ciprofloxacin Tablet.
8.
Product description.
9.
Manufacturer
and
product
registration holder.
10.
Date of revision.
WHAT AXCEL CIPROFLOXACIN TABLET IS
USED FOR
Axcel Ciprofloxacin Tablet is used to
treat
infections
caused
by
ciprofloxacin sensitive pathogens.
HOW
AXCEL
CIPROFLOXACIN
TABLET
WORK
Ciprofloxacin
is
a
synthetic
antibacterial agent against all Gram-
negative
and
Gram-positive
organisms.
BEFORE YOU USE AXCEL CIPROFLOXACIN
TABLET
_-When you must not use it _
Do
not
take
Axcel
Ciprofloxacin
Tablet if:_ _

You are allergic or hypersensitive
to
ciprofloxacin
or
any
component of this medication.

You
are
pregnant
or
nursing
mother.
_-Before you start to use it _
Tell your doctor if:

You
have
history
of
CNS
disorders.

You
have
impaired
liver
and
renal function.

You have been diagnosed with an
enlargement or “bulge” of a large
blood vessel (aortic aneurysm or
large
vessel
peripheral
aneurysm).

You have experienced a previous
episode
of
aortic
dissection
(a
tear in the aorta wall).

You
have
a
family
history
of
aortic
aneurysm
or
aortic
dissection or other risk factors or
predisposing
conditions
(e.g.
connective tissue disorders such
as Marfan syndrome, or vascular
Ehlers-Danlos
syndrome,
or
vascular
disorder
such
as
Takayasu
arteritis,
giant
cell
arteritis, Behcet’s disease, high
blood
pressure,
or
known
atherosclerosis).

You
have
experienced
any
serious adverse reaction in
the
past
when
taking
a
fluoroquinolone
(see
section
Thing to be careful of and Side
effects).
_-Taking other medicines _
You should tell your doctor if you are
taking any medicine as it may interact
with

Summary of Product characteristics

CIPROFLOXACIN
TABLET
AXCEL CIPROFLOXACIN-250MG TABLET
COMPOSITION:
Each tablet contains
Ciprofloxacin Hydrochloride
equivalent to Ciprofloxacin 250mg
PRESENTATION:
Round shaped, white color film-coated tablet debossed with the Kotra
logo on
one side and score line on the reverse side.
AXCEL CIPROFLOXACIN-500MG TABLET
COMPOSITION:
Each tablet contains
Ciprofloxacin Hydrochloride
equivalent to Ciprofloxacin 500mg
PRESENTATION:
White color capsule shaped, film-coated tablet embossed with the word
Kotra
on one side and score line on the reverse side.
INDICATIONS:
_Uncomplicated and complicated infections caused by ciprofloxacin
sensitive _
_pathogens:_
- Infections of the respiratory tract
In the treatment of outpatients with pneumonia due to _ Pneumococcus_,
ciprofloxacin should not be used as a first choice of drug.
Ciprofloxacin can be
regarded as an advisable treatment for pneumonias caused by _
Klebsiella, _
_Enterobacter, Proteus, E.coli, Pseudomonas, Haemophilus, Branhamella,
_
_Legionella _and _Staphylococcus._
- Infections of the middle ear (otitis media)*, of the paranasal
sinuses
(sinusitis), especially if these are caused by gram negative organisms
including _Pseudomonas_ or by _Staphylococcus_.
- Infections of the eyes
- Infections of the kidneys and / or the efferent urinary tract
- Infections of the genital organs, including adnexitis, gonorrhoea,
and
prostatitis
- Infections of the abdominal cavity (e.g. infections of gastro-
intestinal tract or
of the biliary tract, peritonitis)
- Infections of the skin and soft tissues
- Infections of the bones and joints
- Sepsis*
- Infections or imminent risk of infection (prophylaxis) in patients
whose
immune system has been weakened (e.g. patients on immunosuppressants
or
have neutropenia)
*Axcel Ciprofloxacin Tablet should be only used:
- When Pseudomonas is considered AND patient is allergic to
antipseudomonal penicillins/cephalosporins;
- For resistant organisms with no other alternative antibiotics
available
_Inhalation anthrax (post-exposure) in adults and