AMOXYCILLIN/CLAVULANIC ACID 500/125 APOTEX amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet bli

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 574 mg (Equivalent: amoxicillin, Qty 500 mg); potassium clavulanate, Quantity: 149 mg (Equivalent: amoxicillin, Qty 500 mg; Equivalent: clavulanic acid, Qty 125 mg)

Available from:

Apotex Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose

Administration route:

Oral

Units in package:

10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. Skin and skin structure infections. Urinary tract infections (uncomplicated and complicated). Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to AMOXYCILLIN/CLAVULANIC ACID tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused

Product summary:

Visual Identification: OFF-WHITE, OVAL BICONVEX, FILM-COATED TABLETS, SCORED ON BOTH SIDES.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-07-16

Patient Information leaflet

AMOXYCILLIN AND CLAVULANIC ACID 500MG/125MG APOTEX TABLETS
1
AMOXYCILLIN AND
CLAVULANIC ACID
500MG/125MG APOTEX
TABLETS
_Amoxicillin trihydrate and potassium clavulanate _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about amoxycillin and
clavulanic acid. It does not contain
all the available information. It does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Amoxycillin and clavulanic acid is
used to treat a wide range of
infections caused by bacteria. These
infections may affect the chest
(bronchitis or pneumonia), bladder
(cystitis), sinuses (sinusitis), ears
(otitis media) or skin.
_HOW IT WORKS _
Amoxycillin is a type of penicillin
antibiotic. Clavulanic acid is used to
help the amoxycillin work better
against certain types of bacteria.
Amoxycillin and clavulanic acid
works by killing the bacteria that
cause these infections. It will not
work against viral infections such as
colds or the flu, which are caused by
viruses.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
These tablets are not recommended
for children weighing less than 40
kg.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
amoxicillin
•
other penicillins or
cephalosporins
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing

Summary of Product characteristics

1
0AUSTRALIAN PRODUCT INFORMATION
AMOXYCILLIN/CLAVULANIC ACID 500 /125 APOTEX
(AMOXICILLIN TRIHYDRATE AND POTASSIUM
CLAVULANATE) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the following ingredients:
Active Ingredients:
Amoxicillin
(as trihydrate)
Clavulanic acid
(as potassium clavulanate)
Amoxycillin/Clavulanic Acid 500
/125 APOTEX tablets
500 mg
125 mg
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Amoxycillin/Clavulanic Acid 500 /125 APOTEX tablets:
Off-white, oval, biconvex, film-coated and scored on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin and Clavulanic Acid tablets are indicated for short term
treatment of bacterial
infections at the following sites when caused by
amoxicillin/clavulanic acid sensitive, beta-
lactamase
producing
organisms
(refer to section
5.1
PHARMACODYNAMIC PROPERTIES -
MICROBIOLOGY):
•
Skin and skin structure infections.
•
Urinary Tract Infections (complicated and uncomplicated).
•
Upper Respiratory Tract Infections, such as sinusitis, otitis media
and recurrent
tonsillitis
•
Lower Respiratory Tract Infections, including community acquired
pneumonia and
acute exacerbations of chronic bronchitis
Appropriate culture and susceptibility studies should be performed to
identify the causative
organism(s) and determine its (their) susceptibility to Amoxicillin
and Clavulanic Acid tablets.
However, when there is reason to believe an infection may involve any
of the beta-lactamase
producing organisms listed in section 5.1 PHARMACODYNAMIC PROPERTIES -
MICROBIOLOGY,
therapy may be instituted prior to obtaining the results from
bacteriological and susceptibility
studies. Once these results are known, therapy should be adjusted if
appropriate.
2
The
treatment
of
mixed
infections
caused
by
amoxicillin
susceptible
organisms
and
beta-lactamase producing organisms susceptible to Amoxicillin and
Clavulanic Acid tablets
shoul