PYCIP 500mg film coated tablets

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

CIPROFLOXACIN HYDROCHLORIDE

Disponible depuis:

DKSH MALAYSIA SDN BHD

DCI (Dénomination commune internationale):

CIPROFLOXACIN HYDROCHLORIDE

Unités en paquet:

100tablet Tablets

Fabriqué par:

Pymepharco Joint Stock Company

Notice patient

_Consumer Medication Information Leaflet (RiMUP) _
PYCIP FILM COATED TABLETS
Ciprofloxacin hydrochloride (500mg)
1
WHAT IS THIS IN LEAFLET
1.
What PYCIP is used for
2.
How it works
3.
Before you use PYCIP
4.
How to use PYCIP
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PYCIP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PYCIP IS USED FOR
PYCIP can be used to treat or prevent
certain infections caused by bacteria:
Infections of the respiratory tract,
urinary tract, gastrointestinal (GI), skin
and soft tissues, bones and joints.
Bacteria in the blood (Septicemia),
inflammation of the inner wall of the
abdomen (peritonitis), infection in
patients with reduced immunity.
HOW PYCIP WORKS
PYCIP contains ciprofloxacin as active
ingredient. It belongs to a group of
antibiotic called fluoroquinolone.
Antibiotics kill the bacteria or germ
which causes infections.
BEFORE YOU USE PYCIP
-
_When you must not use it _
Do not take PYCIP if you have ever had
a history of hypersensitivity to
ciprofloxacin, any member of the
quinolone class of antimicrobial agents,
or any of the product components.
-
_Before you start to use it _
Tell your healthcare provider about all
your medical conditions, including if
you:
-
Have tendon problems
-
Have central nervous system problems
such as nervousness, extreme emotional
disturbance (agitation), trouble falling
asleep (insomnia), fear or worry
(anxiety), nightmares or mental
emotional disturbance (paranoia).
-
You are breast-feeding a baby;
pregnant, or trying to become pregnant
soon.
-
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,

Résumé des caractéristiques du produit

PYCIP 500MG FILM COATED TABLET
COMPOSITION
_ACTIVE INGREDIENT:_ Each film – coated tablet contains
ciprofloxacin hydrochloride
equivalent to 500 mg of ciprofloxacin.
_OTHER INGREDIENTS:_ Pregelatinized starch, Maize starch, Magnesium
stearate,
Sodium starch glycolate, Opadry white, Titanium dioxide.
PHARMACODYNAMIC
Ciprofloxacin has _in vitro_ activity against a wide range of
gram-negative and gram-
positive microorganisms. The bactericidal action of ciprofloxacin
results from
inhibition of the enzymes topoisomerase II (DNA gyrase) and
topoisomerase IV,
which are required for bacterial DNA replication, transcription,
repair, and
recombination.
The
mechanism
of
action
of
fluoroquinolones,
including
ciprofloxacin, is different from that of penicillins, cephalosporins,
aminoglycosides,
macrolides, and tetracyclines; therefore, microorganisms resistant to
these classes
of drugs may be susceptible to ciprofloxacin and other quinolones.
There is no
known cross-resistance between ciprofloxacin and other classes of
antimicrobials.
In vitro resistance to ciprofloxacin develops slowly by multiple step
mutations.
Ciprofloxacin has been shown to be active against most strains of the
following
microorganisms, both _ in vitro_ and in clinical infections as
described in the
indications and usage section of the package insert for PYCIP:
Aerobic gram-positive microorganisms
_Enterococcus _
_faecalis_
(Many
strains
are
only
moderately
susceptible),
_Staphylococcus aureus_ (methicillin-susceptible strains only), _
Staphylococcus _
_epidermidis_ (methicillin-susceptible strains only), _Staphylococcus
saprophyticus_,
_Streptococcus pneumoniae_ (penicillin-susceptible strains only),
_Streptococcus _
_pyogenes_.
Aerobic gram-negative microorganisms
_Campylobacter jejuni_, _Proteus mirabilis_, _Citrobacter diversus,_
_Proteus vulgaris_,
_Citrobacter freundii,_ _ Providencia rettger_i, _ Enterobacter
cloacae,_ _ Providencia _
_stuartii_, _ Escherichia coli_, _ Pseudomonas aeruginosa_, _
Haemophilus influenzae_,
_Salmonella typhi_, _Hae