Augmentin 625mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amoxicillin trihydrate; Potassium clavulanate

Available from:

Sigma Pharmaceuticals Plc

ATC code:

J01CR02

INN (International Name):

Amoxicillin trihydrate; Potassium clavulanate

Dosage:

500mg ; 125mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103

Patient Information leaflet

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:
•
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 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 or pharmacist

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Augmentin 625 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
500 mg
amoxicillin and potassium clavulanate equivalent to 125 mg of
clavulanic
acid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
F
ilm-coated tablet
White to off-white, oval film-coated tablets debossed with ‘AC’
and a score line one
side. The score line is only to facilitate breaking for ease of
swallowing and not to
divide into equal doses.
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 children
≥
40 kg, this formulation of Augm