Augmentin 625mg tablets

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:

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; GTIN: 5000483111175

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
pharmacis

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
Film-coated tablet
White to off-white, oval shaped tablet debossed with ‘AC’ and a
score line on
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 Augmenti