ENHANCIN TABLET 625MG

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

Amoxicillin Trihydrate; POTASSIUM CLAVULANATE

Dostopno od:

RANBAXY (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

Amoxicillin Trihydrate; POTASSIUM CLAVULANATE

Enote v paketu:

100Tablet Tablets

Izdeluje:

Sun Pharmaceutical Industries Limited

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ENHANCIN TABLET
Amoxicillin/ clavulanic acid (500mg/125mg)
Page 1
WHAT IS IN THIS LEAFLET
1.
What Enhancin Tablet
is used for
2.
How Enhancin Tablet
works
3.
Before
you
start
to
use
Enhancin
Tablet
4.
How to use Enhancin Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Enhancin
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ENHANCIN TABLET IS USED FOR
Enhancin Tablet
are to treat the following
infections:

respiratory tract infections

urinary tract infection

skin and soft tissue infections (e.g.
boils, wound)

dental infections

bone and joint infections.

other infections
HOW ENHANCIN TABLET WORKS
Enhancin
Tablet
is
an
antibiotic
that
contains
amoxicillin
and
clavulanate,
which works by killing bacteria that cause
infections.
BEFORE YOU START TO USE ENHANCIN TABLET
-
_When you must not use it _
Do not take Enhancin Tablet if you:

are
allergic
to
amoxicillin,
clavulanate,
other
penicillin-based
antibiotics,
or
similar
antibiotics
called
cephalosporins
or
any
other
ingredients of this medicine (listed in
Product Description).

have
ever
had
liver
problems
or
jaundice
(yellowing
of
the
skin
and/or
whites
of
the
eyes)
when
taking an antibiotic.
If you are not sure whether you should
start taking Enhancin Tablet, talk to your
doctor or pharmacist.
-
_Before you start to use it _
Tell your doctor if you:

have
viral
infections
(eg:
common
cold)

are being treated for liver or kidney
problems

are not urinating regularly
If you are not sure if any of the above
apply
to
you,
talk
to
your
doctor
or
pharmacist
before
taking
Enhancin
Tablet
.
_Pregnancy and Lactation _
Amoxicillin/
clavulanate
potassium
is
secreted into the breast milk.
Please consult your doctor or pharmacist
if
you
are
pregnant,
planning
for
pregnancy or breast-feeding before using
any medicine.
Avoid the use of the medicine in the first
three months of pregnancy unles

Lastnosti izdelka

1
_For the use only of a Registered Medical Practitioner _
PRESCRIBING INFORMATION
ENHANCIN TABLETS
(Amoxicillin and Clavulanate Potassium Tablets)
To
reduce
the
development
of
drug-resistant
bacteria
and
maintain
the
effectiveness
of
amoxicillin/clavulanate potassium and other antibacterial drugs,
amoxicillin/clavulanate potassium
should be used only to treat or prevent infections that are proven or
strongly suspected to be
caused by bacteria.
COMPOSITION
Each tablet contains:
Amoxicillin trihydrate Ph. Eur. equivalent to Amoxicillin…500 mg
Potassium Clavulanate equivalent to Clavulanic acid….125 mg
_EXCIPIENTS_:
Microcrystalline
Cellulose,
Sodium
Starch
Glycolate,
Colloidal
Silicon
dioxide,
Povidone (K30), Eudragit E 100, Isopropyl Alcohol, Magnesium stearate,
Opadry 03B58965 white,
Polyethylene glycol-400, Methylene chloride
PRODUCT DESCRIPTION
White to off-white film coated oval shaped tablets debossed with
“RX713” on one side and plain on
the other
DESCRIPTION
ENHANCIN
TABLETS
contain
amoxicillin
and
clavulanate
potassium.
Amoxicillin/clavulanate
potassium is an oral antibacterial combination consisting of the
semisynthetic antibiotic amoxicillin
and the β-lactamase inhibitor, clavulanate potassium (the potassium
salt of clavulanic acid).
Amoxicillin is an analog of ampicillin, derived from the basic
penicillin nucleus, 6-aminopenicillanic
acid. The amoxicillin molecular formula is C
16
H
19
N
3
O
5
S•3H
2
O, and the molecular weight is 419.46.
Chemically,
amoxicillin
is
(2_S, _
5_R, _
6_R_)-6-[(_R_)-(-)-2-Amino-2-(_p_-hydroxyphenyl)
acetamido]-3,3-
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid
trihydrate
and
may
be
represented structurally as:
AMOXICILLIN
2
Clavulanic acid is produced by the fermentation of _ Streptomyces
clavuligerus_. It is a β-lactam
structurally related to the penicillins and possesses the ability to
inactivate a wide variety of β-
lactamases by blocking the active sites of these enzymes. Clavulanic
acid is particularly active
against
the
clinically
imp