AUGMENTIN 250 MG TABLETS

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT

Fáanlegur frá:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC númer:

J01CR02

Lyfjaform:

FILM COATED TABLETS

Samsetning:

AMOXICILLIN AS TRIHYDRATE 250 MG; CLAVULANIC ACID AS POTASSIUM SALT 125 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Meðferðarhópur:

AMOXICILLIN AND ENZYME INHIBITOR

Lækningarsvæði:

AMOXICILLIN AND ENZYME INHIBITOR

Ábendingar:

Augmentin is indicated for the treatment of the following infections in adults and children :• Acute bacterial sinusitis (adequately diagnosed)• Otitis media infection• Acute pharyngitis• Cystitis• Pyelonephritis• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.

Leyfisdagur:

2022-08-31

Upplýsingar fylgiseðill

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physicians prescription only
AUGMENTIN 250 MG TABLETS
FILM-COATED TABLETS.
EACH TABLET CONTAINS: 250 MG AMOXICILLIN (AS TRIHYDRATE)
125 MG CLAVULANIC ACID (AS POTASSIUM SALT)
For a list of the inactive and allergenic ingredients in the
preparation – see
section 2 Important information about some of the ingredients of the
medicine
and section 6 Additional information.
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:
•
sinus infections
•
middle ear infection
•
acute pharyngitis
•
urinary tract infections
•
skin and soft tissue infections including dental 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.

Vara einkenni

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Augmentin 500 mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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)
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•
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).
For adults and children
≥
40 kg,