AUGMENTIN 500 MG TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

J01CR02

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

AMOXICILLIN AS TRIHYDRATE 500 MG; CLAVULANIC ACID AS POTASSIUM SALT 125 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

SMITHKLINE BEECHAM LIMITED, UK

المجال العلاجي:

AMOXICILLIN AND ENZYME INHIBITOR

الخصائص العلاجية:

Augmentin is indicated for the treatment of the following infections in adults and children :• Acute bacterial sinusitis (adequately diagnosed)• Acute Otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed)• Community acquired pneumonia• Cystitis• Pyelonephritis• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.• Bone and joint infections, in particular osteomyelitis.

تاريخ الترخيص:

2017-08-28

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to
a physician’s prescription only
AUGMENTIN 500 MG TABLETS
FILM-COATED TABLETS.
EACH TABLET CONTAINS: 500 MG AMOXICILLIN (AS TRIHYDRATE)
125 MG CLAVULANIC ACID (AS POTASSIUM SALT)
List of the additional ingredients is detailed in section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have further questions, refer to the physician or the
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them even if it seems to you that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Augmentin 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.
Augmentin is an antibiotic that 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” whose action can sometimes
be stopped (become inactive). The other active component
(clavulanic acid) prevents this from happening.
THERAPEUTIC GROUP
Amoxicillin: Penicillin antibiotic group.
Clavulanic acid: Beta-lactamase enzyme inhibitors.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
you are sensitive (allergic) to amoxicillin, clavulanic acid,
penicillin or any of the additional ingredients contained
in the medicine (listed in section 6)
•
you have ever had a severe allergic reaction to any other
antibiotic. This can include a skin rash or swelling of the
face or throat
•
you have ever had liver problems or jaundice (yellowing
of the skin) when taking an antibiotic.
→
DO NOT TAKE AUGMENTIN IF ANY OF THE ABOVE APPLY
TO YOU. If you are not sure, talk to your ph

خصائص المنتج

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AUGMENTIN 500 MG TABLETS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Augmentin 500 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
500 mg amoxicillin
and potassium clavulanate equivalent to 125 mg of clavulanic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval film-coated tablets debossed with ‘AC’
and a score line on one
side. The score line is only to facilitate breaking for ease of
swallowing and not to divide
into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Augmentin is indicated for the treatment of the following infections
in adults and children (see
sections 4.2, 4.4 and 5.1):
•
Acute bacterial sinusitis (adequately diagnosed)
•
Acute otitis media
•
Acute exacerbations of chronic bronchitis (adequately diagnosed)
•
Community acquired pneumonia
•
Cystitis
•
Pyelonephritis
•
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental
abscess with spreading cellulitis.
•
Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
Page
2
of
18
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when
doses are stated in terms of an individual component.
The dose of Augmentin that is selected to treat an individual
infection should take into
account:
•
The expected pathogens and their likely susceptibility to
antibacterial agents (see
section 4.4)
•
The severity and the site of the infection
•
The age, weight and renal function of the patient as shown below.
The use of alternative presentations of Augmentin (e.g. those that
provide higher doses of
amoxicillin and/or different ratios of amoxicillin to clavulanic acid)
should be considered as
necessary (see sections 4.4 and 5.1)