Augmentin 250 mg/125 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin trihydrate; potassium clavulanate

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin trihydrate; potassium clavulanate

Dosage:

250/125 milligram(s)

Pharmaceutical form:

Film-coated tablet

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:

Marketed

Authorization date:

1982-09-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN 250 MG/125 MG FILM-COATED TABLETS
Amoxicillin/clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you (or for your child) only. Do
not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
-
If you get any side effects, talk to your doctor or pharmacist. 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 take Augmentin
3.
How to take 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 adults and children to treat the following
infections:
•
sinus infections
•
urinary tract infections
•
skin infections
•
dental infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AUGMENTIN
DO NOT TAKE AUGMENTIN:
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other
ingredients of this medicine (listed in section 6)
•
if you 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 you have ever had liver problems or jaundice (yellowing of the
skin) when taking an
antibiotic.

DO NOT TAKE AUGMENTIN IF ANY OF THE ABOVE APPLY TO YOU. If you are not
sure, talk to
your doctor

Summary of Product characteristics

Health Products Regulatory Authority
08 November 2023
CRN00DFX0
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin 250 mg/125 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
250 mg amoxicillin with potassium clavulanate equivalent
to 125 mg of clavulanic acid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval shaped tablets debossed with ‘Augmentin’
on one side
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)

● Cystitis

● Pyelonephritis

● Cellulitis

● Animal bites

● Severe dental abscess with spreading cellulitis.
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 children
≥
40 kg, this formulation of Augmentin provides a total daily dose of
750 mg amoxicillin/375 mg
clavulanic acid, when administered as recommended below. If it is
considered that a higher daily dose of amoxicillin is required,
it is recommended that anothe