MOXICLAV 625MG TABLET

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

CLAVULANIC ACID; AMOXYCILLIN

Mevcut itibaren:

KOMEDIC SDN BHD

INN (International Adı):

CLAVULANIC ACID; AMOXYCILLIN

Paketteki üniteler:

20 Tablet Tablets; 16 Tablet Tablets

Tarafından üretildi:

MEDOCHEMIE LTD (Factory B)

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MOXICLAV TABLET
Amoxicillin/ Clavulanic acid (500mg/ 125mg or 875mg/ 125mg)
1
WHAT IS IN THIS LEAFLET
1.
What MOXICLAV is used for
2.
How MOXICLAV works
3.
Before you use MOXICLAV
4.
How to use MOXICLAV
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
MOXICLAV
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT MOXICLAV IS USED FOR
MOXICLAV
is
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 MOXICLAV WORKS
MOXICLAV 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 MOXICLAV
_When you must not use it _
Do not take MOXICLAV:
-
If you are allergic (hypersensitive) to
amoxicillin,
clavulanic
acid,
penicillin
or
any
of
the
other
ingredients of MOXICLAV (listed at
the end of this leaflet)
-
If you have ever had a severe allergic
(hypersensitive) reaction to any other
antibiotic. This can include a skin
rash or swelling of the face or neck
-
If you have ever had liver problems
or jaundice (yellowing of the skin)
when taking an antibiotic
_Before you start to use it _
_Tell your doctor or pharmacist if you: _
•
have glandular fever
•
are being treated for liver or kidney
problems
•
are not passing water regularly
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking MOXICLAV.
In
some
cases,
your
doctor
may
investigate the type of bacteria that is
causing your infection.
Depending on the results, you may be
given
a
different
strength
of
MOXICLAV or a dif

Ürün özellikleri

1
MOXICLAV
1.
NAME OF THE MEDICINAL PRODUCT
MOXICLAV 625 mg film-coated tablets
MOXICLAV 1g film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of MOXICLAV 625 mg contains amoxicillin trihydrate
equivalent to 500mg amoxicillin base and potassium
clavulanate equivalent to 125mg clavulanic acid.
Each tablet of MOXICLAV 1 g contains amoxicillin trihydrate equivalent
to 875 mg amoxicillin base and potassium
clavulanate equivalent to 125mg clavulanic acid.
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, convex, capsule-shaped, film-coated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The administration of MOXICLAV is indicated in the treatment of
infections caused by susceptible microorganisms, such as:
LOWER RESPIRATORY TRACT INFECTIONS
caused by β-lactamase producing strains of
_Haemophilus influenza _
and
_Branhamella _
_catarrhalis _
OTITIS MEDIA
caused by β-lactamase producing strains of
_Haemophilus influenza _
and
_Branhamella catarrhalis _
SINUSITIS
caused by β-lactamase producing strains of
_Haemophilus influenza _
and
_Branhamella catarrhalis _
UROGENITARY TRACT INFECTIONS
caused by, β-lactamase producing strains of
_Escherichia coli_
,
_Klebsiella _
spp. And
_Enterobacter _
_spp_
.
SKIN AND SKIN STRUCTURE INFECTIONS
caused by β-lactamase producing strains of
_Staphylococcus aureus_
,
_Escherichia coli _
and
_Klebsiella spp_
.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual administered dose is:
Adults and children over 14 years old: In severe infections, one
MOXICLAV tablet (875 + 125) mg every 12 hours or one
MOXICLAV tablet (500 + 125) mg every 8 hours. In mild to moderate
infections, one MOXICLAV tablet (250 + 125) mg
every 8 hours or one MOXICLAV tablet (500 + 125) mg every 12 hours.
For dental infections one MOXICLAV tablet (250 + 125) mg every 8 hou