Augmentin 250/62 SF oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amoxicillin trihydrate; Potassium clavulanate

Available from:

GlaxoSmithKline UK Ltd

ATC code:

J01CR02

INN (International Name):

Amoxicillin trihydrate; Potassium clavulanate

Dosage:

50mg/1ml ; 12.5mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103; GTIN: 5000483207106

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN
250/62 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

Summary of Product characteristics

OBJECT 1
AUGMENTIN 250/62 SUSPENSION
Summary of Product Characteristics Updated 04-May-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Augmentin 250/62 Suspension
2. Qualitative and quantitative composition
When reconstituted, every ml of oral suspension contains amoxicillin
trihydrate equivalent to 50 mg
amoxicillin and potassium clavulanate equivalent to 12.5 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