AUGMENTIN TABLET 1G

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE

Unit dalam pakej:

14Tablet Tablets

Dikeluarkan oleh:

SMITHKLINE BEECHAM PHARMACEUTICALS

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
1
AUGMENTIN TABLET
Amoxicillin trihydrate/ Potassium clavulanate (500 mg/125 mg, 875
mg/125 mg)
What is in this leaflet
1.
What Augmentin is used for
2.
How Augmentin works
3.
Before you use Augmentin
4.
How to use Augmentin
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Augmentin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
What Augmentin is used for
Augmentin is an antibiotic used
in adults and children to treat the
following infections:

middle ear and sinus
infections

respiratory tract infections

urinary tract infections

skin and soft tissue infections
including dental infections

bone and joint infections.
How Augmentin works
Augmentin is an antibiotic and
works by killing bacteria that
cause infections. It contains two
different medicines called
amoxicillin and clavulanic acid.
Amoxicillin belongs to a group
of medicines called “penicillins”
that can sometimes be stopped
from working (made inactive).
The other active component
(clavulanic acid) stops this from
happening.
Before you use Augmentin
-
When you must not use it
Do not take Augmentin:

if you are allergic
(hypersensitive) to
amoxicillin, clavulanic acid,
other penicillin based
antibiotics, or similar
antiobiotics called
cephalosporins. if you have
ever had liver problems or
jaundice (yellowing of the
skin and/or whites of the eyes)
when taking an antibiotic.
Do not take Augmentin if any of
the above applies to you. If you
are not sure, talk to your doctor
or pharmacist before taking
Augmentin.
-
Before you start to use it
Talk to your doctor or
pharmacist before taking this
medicine if you:

have ever had an allergic
reaction to any other
antibiotics or medicines. This
might include a skin rash or
swelling of the face or neck

have glandular fever
(mononucleosis - viral
infection that normally
transmitted through saliva and
causes sore throat, swollen
glands and fever)

are taking medicines, such as

Ciri produk

CONFIDENTIAL
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[GSK logo]
AUGMENTIN TABLETS
Amoxicillin trihydrate - Potassium clavulanate
QUALITATIVE AND QUAN TITATIVE COMPOSITION
AUGMENTIN 625 mg tablets: Each tablet contains 500 mg amoxicillin (as amoxicillin
trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
AUGMENTIN 1 g tablets: Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate)
and 125 mg clavulanic acid (as potassium clavulanate).
PHARMACEUTICAL FORM
AUGMENTIN 625 mg tablets: A white to off white oval shaped , film coated tablet, debossed
with ‘AC’ and a score line on one side and plain on the other side.
AUGMENTI N 1 g tablets: A white to off -white capsule -shaped , film-coated tablet, debossed with
‘AC’ on both sides and a score line on one side.
CLINICAL PARTICULARS
Indications
AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the
commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase
inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of
organisms, including many resistant to other beta- lactam antibiotics.
AUGMENTIN should be used in accordance with local official antibiotic -prescribing guidelines
and local susceptibility data.
AUGMENTIN oral presentations for twice daily dosing, are indicated for short -term treatment of
bacterial infections at the following sites:
Upper respiratory tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and
bronchopneumonia.
Genito -urinary tract infections e.g. cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections.
Bone and joint infections e.g. osteomyelitis.
Dental infections e.g. dentoalveolar abscess