SIPROSAN FILM TABLET 500MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
02-11-2017
Ciri produk Ciri produk (SPC)
11-01-2018

Bahan aktif:

CIPROFLOXACIN HYDROCHLORIDE

Boleh didapati daripada:

ANTAH PHARMA SDN. BHD.

INN (Nama Antarabangsa):

CIPROFLOXACIN HYDROCHLORIDE

Unit dalam pakej:

14Tablet Tablets

Dikeluarkan oleh:

Drogsan Ilaclari San.ve Tic.A.S

Risalah maklumat

                                _Consumer medicine information leaflet (RIMUP)_
SIPROSAN FILM TABLET
Ciprofloxacin Hydrochloride (500mg)
WHAT IS IN THIS LEAFLET
1. What Siprosan is used for
2. How Siprosan works
3. Before you use Siprosan
4. How to use Siprosan
5. While you are using Siprosan
6. Side effects
7. Storage and Disposal of Siprosan
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT SIPROSAN IS USED FOR
It is used to treat:
-Infections of the respiratory tract.
-Infections of the middle ear and the
sinuses.
-Infections of the eyes.
-Infections of the kidneys and/or the
urinary tract.
-Infections of the genital organs.
-Infections of the abdominal cavity.
-Infections of the skin and soft
tissue.
-Infections of the bones and joints.
-Sepsis (severe infection).
HOW SIPROSAN WORKS
Siprosan is
an antibiotic belonging
to
the
fluoroquinolone family. The
active
substance
is
Ciprofloxacin.
_Siprosan _
works
by
killing bacteria
that cause infections. It only works
with specific strains of bacteria.
BEFORE YOU USE SIPROSAN
_- When you must not use it_
Do not take Siprosan:
-If you are hypersensitive to, or have
had
an
allergic
reaction
to
Ciprofloxacin or other quinolones.
Symptoms of an allergic reaction
may include: cough, shortness of
breath,
wheezing
or
difficulty
breathing; swelling of the face, lips,
tongue, throat or other parts of the
body; rash, itching or hives on the
skin;
fainting;
or
hay
fever-like
symptoms.
If you think you are having an allergic
reaction, stop taking the medicine and
contact your doctor immediately or
go to the nearest hospital.
- If you are children who have not
finished your skeletal growth period
yet.
_Pregnancy and lactation_
- Do not take Siprosan if you are
pregnant, trying to get pregnant or
think you may be pregnant.
- Do not take Siprosan if you are
breast-feeding. Ask
your
doctor
or
pharmacist for advice before taking
any medicine.
-
_Before you start to use it_
Tell your doctor if:
-you
have
history of
diarrhea
induced by antibiotic.
-you have liver problem
                                
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Ciri produk

                                Name of Product
Siprosan Film Tablet
Name and Strength of Active Ingredient
Ciprofloxacin, 500 mg
Dosage Form
Film coated tablet
Product Description
White oblong tablet
Pharmacodynamics
Ciprofloxacin is a new synthetic fluoroquinolone antibacterial agent.
Ciprofloxacin inhibits DNA-gyrase, in susceptible organism. Since it
has bactericidal effect during both logarithmic and stationary phases
of growth in susceptible organism, there is almost no possibility of
recurrence. Unlike 13-lactam antibiotics, ciprofloxacin is very active
against susceptible bacteria because it has no parallel resistance
with
other antibiotics. Ciprofloxacin has a spectrum of activity on the
following
bacterias: E. Coli, Shigella, Salmonella, Klebsiella, Citrobacter,
Enterobacter, Edwardsiella, Serratia, Hafnia, Proteus, Providencia,
Yersinia, Morganella, Vibrio, Pasteurella, Aeromanas, Pleisomonas,
Haemophilus, Gardnerella, Pseudomonas aeruginosa, Legionella,
Neisseria, Campylobacter, Acinobacter, Moraxella, Flavobacterium,
Bruceila, Streptococcus pyogenes and pneumoniae, Staphylococcus,
Corynebacterium, Fusobacterium, Peptococcus, Peptostreptococcus,
Eubacterium, Actinomyces, Mycoplasma, Ureaplasma. Ciprofloxacin
generally is less active against Gram-positive like most of
Streptococcus
and Streptococcus faecalis than Gram-negative bacteria. Most of the
Anaerobes are not sensitive.
Pharmacokinetics
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after oral administration. The
absolute
bioavailability is approximately 70% with no substantial loss by first
pass metabolism. Maximum serum concentrations are attained in 1 to
2 hours after oral dosing. The serum elimination half-life in subjects
with
normal renal function is approximately 4 hours. Serum concentrations
increase proportionately with doses up to 1000 mg.
Approximately 40 to 50% of an orally administered dose is excreted
in the urine as unchanged drug. The urinary excretion of ciprofloxacin
is virtually complete within 24 hours aft
                                
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