AUGMENTIN DUO FORTE tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 1004.43 mg (Equivalent: amoxicillin, Qty 875 mg); potassium clavulanate, Quantity: 148.91 mg (Equivalent: clavulanic acid, Qty 125 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; sodium starch glycollate; titanium dioxide; hypromellose; macrogol 6000; macrogol 4000

Administration route:

Oral

Units in package:

60 tablets, 10 tablets, 2 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Augmentin Duo Forte is indicated for the short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology) *Urinary tract infections (uncomplicated and complicated); *Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis; *Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis; *Skin and skin structure infection Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to Augmentin Duo Forte. However when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the product information, therapy may be instituted prior to obtaining the results of bacteriological and susceptibility studies. Once the results are known, therapy should be adjusted should be adjusted if appropriate. The treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to Augmentin Duo Forte should not require the addition of another antibiotic due to the amoxycillin content of Augmentin Duo Forte.

Product summary:

Visual Identification: a white to off-white capsule-shaped film coated tablet, monogrammed with an 'A' and 'C' and a breakline on one side and 'A' and 'C' only on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-01-08

Patient Information leaflet

1
AUGMENTIN
® DUO &
AUGMENTIN
® DUO FORTE TABLETS
_Amoxicillin trihydrate & Potassium clavulanate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take AUGMENTIN DUO
or AUGMENTIN DUO FORTE
tablets.
This leaflet answers some
common questions about
AUGMENTIN DUO and
AUGMENTIN DUO FORTE tablets.
It does not contain all of the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Sometimes new risks
are found even when a medicine
has been used for many years.
Your doctor has weighed the
expected benefits of you taking
AUGMENTIN tablets against the
risks this medicine could have for
you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the
medicine.
You may need to read it again.
WHAT ARE AUGMENTIN
DUO AND AUGMENTIN
DUO FORTE TABLETS
USED FOR?
AUGMENTIN tablets contain two
active ingredients. One of these
is a penicillin called amoxicillin
and the other is clavulanic acid.
AUGMENTIN tablets belong to the
penicillin group of antibiotics.
AUGMENTIN tablets are used for
the short term treatment of a
wide range of infections caused
by bacteria. These infections may
affect the chest (e.g. bronchitis or
pneumonia), bladder (e.g.
cystitis), sinuses (e.g. sinusitis),
the ears (e.g. otitis media) or the
skin.
AUGMENTIN tablets work by
killing the bacteria that cause
these infections. AUGMENTIN
tablets will not work against
infections caused by viruses such
as colds or the flu.
Your doctor may prescribe
AUGMENTIN tablets for another
use. If you want more
information, ask your doctor.
There is no evidence that
AUGMENTIN tablets are addictive.
BEFORE YOU TAKE
AUGMENTIN DUO OR
AUGMENTIN DUO
FORTE TABLETS
_ _
_DO NOT TAKE AUGMENTIN _
_TABLETS IF: _
•
you have had an allergic
reaction to penicillin or similar
types of antibiotics (such as
cephalosporins) or any of the
ingredients contained in
AUGMENTIN DUO or
AUGMENTIN DUO FORTE
tablets.
The in

Summary of Product characteristics

Augmentin-tablets-pi
1
AUSTRALIAN PRODUCT INFORMATION
AUGMENTIN
® DUO AND AUGMENTIN
® DUO FORTE (AMOXICILLIN TRIHYDRATE
AND POTASSIUM CLAVULANATE) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin Trihydrate and Potassium Clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AUGMENTIN DUO and AUGMENTIN DUO FORTE tablets (AUGMENTIN TABLETS) are
combination
products
containing
the
semisynthetic
antibiotic,
amoxicillin
(as
the
trihydrate) and the
β
-lactamase inhibitor, potassium clavulanate (as the potassium salt
of clavulanic acid).
Each AUGMENTIN DUO FORTE Tablet contains 875mg amoxicillin as the
trihydrate and
125mg clavulanic acid as the potassium salt.
Each AUGMENTIN DUO Tablet contains 500mg amoxicillin as the trihydrate
and 125mg
clavulanic acid as the potassium salt.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AUGMENTIN DUO FORTE TABLETS: A white to off-white capsule shaped film
coated tablet,
debossed with “AC” and a scoreline on one side and “AC” only
on the other side.
AUGMENTIN DUO TABLETS: A white, oval shaped, biconvex film coated
tablet debossed
with “AC” and a scoreline on one side and plain on the other.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AUGMENTIN TABLETS are indicated for short term treatment of bacterial
infections at the
following sites when caused by sensitive organisms (refer to
Microbiology):
­
Urinary Tract Infections (uncomplicated and complicated)
­
Lower Respiratory Tract Infections, including community acquired
pneumonia and
acute exacerbations of chronic bronchitis
­
Upper Respiratory Tract Infections, such as sinusitis_, _ otitis media
and recurrent
tonsillitis
­
Skin and Skin Structure Infection.
Augmentin-tablets-pi
2
Appropriate
culture
and
susceptibility
studies
should be
performed to
identify the
causative organism(s) and determine its (their) susceptibility to
AUGMENTIN TABLETS.
However, when there is reason