Augmentin DUO 400mg/57mg/5ml powder for oral suspension

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

AMOXICILLIN, CLAVULANIC ACID

Commercializzato da:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Codice ATC:

J01CR02

INN (Nome Internazionale):

AMOXICILLIN 80 mg/ml CLAVULANIC ACID 11.4 mg/ml

Forma farmaceutica:

POWDER FOR ORAL SUSPENSION

Composizione:

AMOXICILLIN 80 mg/ml CLAVULANIC ACID 11.4 mg/ml

Tipo di ricetta:

POM

Area terapeutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2006-03-28

Foglio illustrativo

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PACKAGE LEAFLET
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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 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

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Augmentin DUO 400 mg/57 mg/5 ml powder for oral suspension
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.
Excipients with known effect
Every ml of oral suspension contains 3.33 mg aspartame (E951). The
flavouring in Augmentin
contains maltodextrin (glucose) (see section 4.4).
This medicine contains 1.77 mg sodium benzoate (E211) per ml (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
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•
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 amoxicil