Augmentin Paediatric 125 mg/31.25 mg per 5 ml Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

125 mg/31.25 mg/5ml

Pharmaceutical form:

Powder for oral suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

Authorization status:

Marketed

Authorization date:

1983-07-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN PAEDIATRIC 125 MG/31.25 MG PER 5 ML POWDER FOR ORAL
SUSPENSION
amoxicillin/clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR THEM.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine is usually prescribed for a baby or child. Do not pass
it on to others. It may harm
them, even if their signs of illness are the same as your child’s.
-
If your child gets any side effects, talk to their doctor, pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Augmentin is and what it is used for
2.
What you need to know before you give Augmentin
3.
How to give Augmentin
4.
Possible side effects
5.
How to store Augmentin
6.
Contents of the pack and other information
1.
WHAT AUGMENTIN IS AND WHAT IT IS USED FOR
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.
Augmentin is used in babies 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE AUGMENTIN
DO NOT GIVE YOUR CHILD AUGMENTIN:
•
if they are allergic to amoxicillin, clavulanic acid, penicillin or
any of the other ingredients of this
medicine (listed in section 6).
•
if they have ever had a severe allergic reaction to any other
antibiotic. This can include a skin rash
or swelling of the face or throat.
•
if they have ever had l

Summary of Product characteristics

Health Products Regulatory Authority
08 November 2023
CRN00DFX0
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin Paediatric 125 mg/31.25 mg per 5 ml Powder for Oral
Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, every ml of oral suspension contains amoxicillin
trihydrate equivalent to 25 mg amoxicillin and potassium
clavulanate equivalent to 6.25 mg of clavulanic acid.
Excipients with known effect
Every ml of oral suspension contains 2.5 mg aspartame (E951). The
flavouring in Augmentin 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.
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.
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)

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