Augmentin 125/31 SF oral suspension

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Potassium clavulanate; Amoxicillin trihydrate

Disponible desde:

GlaxoSmithKline UK Ltd

Código ATC:

J01CR02

Designación común internacional (DCI):

Potassium clavulanate; Amoxicillin trihydrate

Dosis:

6.25mg/1ml ; 25mg/1ml

formulario farmacéutico:

Oral suspension

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05010103; GTIN: 5000483207205

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN 125/31 SUSPENSION
CO-AMOXICLAV (AMOXICILLIN AND 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 liver problems or jaundice

Ficha técnica

OBJECT 1
AUGMENTIN 125/31 SUSPENSION
Summary of Product Characteristics Updated 04-May-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Augmentin 125/31 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
Contains 2.5 mg of aspartame (E951) per ml.
Contains maltodextrin (glucose).
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 different ratios of amoxicillin to clavulanic acid) should be
considered as necessary (see sections
4.4 and 5.1).
For adults and chil