CHEMMART AMOXYCILLIN AND CLAVULANIC ACID 875mg/125mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate,potassium clavulanate

Available from:

Apotex Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Authorization status:

Registered

Patient Information leaflet

CHEMMART AMOXYCILLIN
AND CLAVULANIC ACID
875MG/125MG 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 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 or difficulty breathing
•
swelling of the face, lips, tongue,

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
CHEMMART AMOXYCILLIN AND CLAVULANIC ACID
875MG/125MG (AMOXYCILLIN TRIHYDRATE AND POTASSIUM
CLAVULANATE) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amoxicillin trihydrate equivalent to amoxicillin
875 mg and potassium
clavulanate equivalent to clavulanic acid 125mg.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
CHEMMART -AMOXYCILLIN AND CLAVULANIC ACID AMOXICILLIN 875 MG/125MG
TABLETS:
White to off-white oblong film-coated tablets with bevelled edges,
scored and debossed, with
875/125 on one side and debossed with AMC on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxycillin and Clavulanic Acid tablets are indicated for short term
treatment of bacterial
infections at the following sites when caused by sensitive organisms
(refer to section 5.1
PHARMACODYNAMIC PROPERTIES - MECHANISM OF ACTION, 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 Amoxycillin
and Clavulanic Acid tablets.
However, when there is reason to believe an infection may involve any
of the beta-lactamase
producing organisms listed above, 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 by amoxicillin susceptible
organisms and beta-
lactamase producing organisms susceptible to Amoxycillin and
Clavulanic Acid tablets should
not require the addition of anot