AUGMENTIN SUSPENSION 400 MG5 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J01CR02

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

CLAVULANIC ACID AS POTASSIUM SALT 11.4 MG/ML; AMOXICILLIN AS TRIHYDRATE 80 MG/ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Therapeutic area:

AMOXICILLIN AND ENZYME INHIBITOR

Therapeutic indications:

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.• Recurrent tonsillitis

Authorization date:

2022-09-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physicians prescription only
AUGMENTIN SUSPENSION 400 MG/5 ML
POWDER FOR PREPARATION OF ORAL SUSPENSION
Each 5 ml of suspension contains:
400 mg amoxicillin (AS TRIHYDRATE)
57 mg clavulanic acid (as potassium salt)
Each 1 ml of suspension contains:
80 mg amoxicillin (AS TRIHYDRATE)
11.4 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 pharmacist.
This medicine has been prescribed for you/your child. 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, children and babies 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
∙
recurrent tonsil infections.
There are no clinical data for patients under two months of age.
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 or your child are/is sensitive (allergic) to amoxicillin,
clavulanic acid,
penicillin or any of

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Augmentin
Suspension 400 mg/5 ml
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, every ml of oral suspension contains amoxicillin
trihydrate equivalent to 80 mg
amoxicillin and potassium clavulanate equivalent to 11.4 mg of
clavulanic acid.
5ml of oral suspension contains amoxicillin trihydrate equivalent to
400mg amoxicillin and potassium
clavulanate equivalent to 57mg of clavulanic acid.
Excipients with known effect
Every ml of oral suspension contains 2.5 mg aspartame (E951).
The flavouring in Augmentin
Suspension 400 mg/5 ml
contains maltodextrin (glucose) and traces of
benzyl alcohol (see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white powder.
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.
•
Recurrent tonsillitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Page
2
of
16
There are no clinical data for Augmentin 7:1 formulations for patients
under 2 months of age.
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 th