Augmentin-Duo 400 mg/57 mg/5 ml Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLAVULANATE POTASSIUM; Amoxicillin trihydrate

Available from:

Imbat Limited

ATC code:

J01CR; J01CR02

INN (International Name):

CLAVULANATE POTASSIUM; Amoxicillin trihydrate

Dosage:

400/57 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:

Authorised

Authorization date:

2008-10-17

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN-DUO
® 400MG/57MG/5ML
POWDER FOR ORAL SUSPENSION
(amoxicillin and clavulanic acid)
Your medicine is available using the above name, but will be
referred to as ‘Augmentin’ throughout this leaflet.
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 your 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 allergi

Summary of Product characteristics

Health Products Regulatory Authority
03 July 2019
CRN0095H4
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin-Duo 400 mg/57 mg/5 ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted ‘Augmentin-Duo suspension’ contains
amoxicillin trihydrate equivalent to 400 mg amoxicillin and
potassium clavulanate equivalent to 57 mg clavulanic acid.
Excipients: Aspartame (E951), maltodextrin.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
_Product imported from Italy, Poland and Romania:_
Dry white powder for reconstitution with yellowish grains and a
characteristic odour.
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
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