AUGMENTIN-DUO 400/57 MG/5ml Powder for Oral Suspension

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM

Saatavilla:

IMED Healthcare Ltd.

ATC-koodi:

J01CR02

INN (Kansainvälinen yleisnimi):

AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM

Annos:

400/57 MG/5ml

Lääkemuoto:

Powder for Oral Suspension

Prescription tyyppi:

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

Terapeuttinen alue:

Combinations of penicillins, incl. beta-lactamase inhibitors

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-05-11

Pakkausseloste

PACKAGE LEAFLET - INFORMATION FOR THE USER 
AUGMENTIN-DUO 400 MG/57 MG/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 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�

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin-Duo 400 mg/57 mg/5ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, every ml of oral suspension contains amoxicillin
trihydrate equivalent to 80mg amoxicillin and
potassium clavulanate equivalent to 11.4mg clavulanic acid.
Each 5ml of reconstituted suspension contains amoxicillin trihydrate
equivalent to 400mg amoxicillin and potassium
clavulanate equivalent to 57mg 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 Poland:_
Dry white powder for reconstitution with yellowish grains & 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.
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