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: 151.92 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; propylene glycol; purified talc; ethylcellulose

Administration route:

Oral

Units in package:

10 tablets, 60 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 coloured capsule-shaped film coated tablet, debossed with 'l 07' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-05-15

Patient Information leaflet

AUGMENTIN DUO & AUGMENTIN DUO FORTE tablets
1
AUGMENTIN DUO &
AUGMENTIN DUO FORTE TABLETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING AUGMENTIN DUO OR AUGMENTIN DUO FORTE TABLETS?
AUGMENTIN DUO or AUGMENTIN DUO FORTE tablets contains the active
ingredients amoxicillin and clavulanic acid.
AUGMENTIN tablets are used for the short term treatment of a wide
range of infections caused by bacteria.
For more information, see Section 1. Why am I using AUGMENTIN DUO or
AUGMENTIN DUO FORTE tablets?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AUGMENTIN DUO OR AUGMENTIN DUO FORTE
TABLETS?
Do not use if you have ever had an allergic reaction to amoxicillin
trihydrate, potassium clavulanate, penicillin or similar types
of antibiotics (such as cephalosporins), or any of the ingredients
listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
AUGMENTIN DUO or AUGMENTIN DUO FORTE tablets?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AUGMENTIN DUO or AUGMENTIN DUO FORTE
tablets and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE AUGMENTIN DUO OR AUGMENTIN DUO FORTE TABLETS?
•
Follow the directions given to you by your doctor and pharmacist.
Their directions may differ from the information
contained in this leaflet.
More instructions can be found in Section 4. How to take AUGMENTIN DUO
or AUGMENTIN DUO FORTE tablets?
in the full
CMI.
5.
WHAT SHOULD I KNOW WHILE USING AUGMENTIN DUO OR AUGMENTIN DUO FORTE
TABLETS?
THINGS YOU
SHOULD DO
•
Take AUGMENTIN tablets exactly as your doctor has prescribed.
•
Tell your doctor if, for any reason, you have not taken

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 coloured capsule shaped film
coated tablet,
debossed with “I 07” on one side and plain on the other side.
AUGMENTIN DUO TABLETS: A white coloured capsule shaped film coated
tablet, debossed
with “I 06” on one side and plain on the other side.
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.
Appropriate
culture
and
susceptibility
studies
should be
performed to
identify the
causative organism(s) and determine its (their) susceptibility to
AUGMENTIN TABLETS.
Augmentin-tablets-pi
2
However, when there is reason to believe an infection may involve any
of the
β
-lactamase
producing organisms listed above, therapy may be instituted prior to
obtaining the