AMOXYCLAV GENERICHEALTH 875/125 amoxicillin 875 mg and clavulanic acid 125 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 1006.25 mg; potassium clavulanate, Quantity: 148.875 mg

Available from:

Medreich Australia Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; propylene glycol; isopropyl alcohol; hypromellose; ethylcellulose; croscarmellose sodium; dichloromethane; microcrystalline cellulose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit

Administration route:

Oral

Units in package:

2, 60, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amoxyclav generichealth 500/125 and Amoxyclav generichealth 875/125 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 Amoxicillin 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 Amoxicillin and clavulanic acid tablets should not require the addition of another antibiotic due to the amoxicillin content of these products.

Product summary:

Visual Identification: A white elongated capsule shaped film coated tablet.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-01-17

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
AMOXYCLAV GENERICHEALTH 500/125 &
AMOXYCLAV GENERICHEALTH 875/125
(AMOXICILLIN TRIHYDRATE & POTASSIUM CLAVULANATE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you take AmoxyClav
generichealth 500/125 or
AmoxyClav generichealth
875/125 tablets.
This leaflet answers some
common questions about
AmoxyClav generichealth
500/125 and AmoxyClav
generichealth 875/125 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
AmoxyClav generichealth
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 AMOXYCLAV
GENERICHEALTH 500/125 &
AMOXYCLAV
GENERICHEALTH 875/125
ARE USED FOR
AmoxyClav generichealth
tablets contain two active
ingredients. One of these is a
penicillin called amoxicillin and
the other is clavulanic acid.
AmoxyClav generichealth
tablets belong to the penicillin
group of antibiotics.
AmoxyClav generichealth
tablets are used for the short-
term treatment of a wide range
of infections caused by bacteria.
These infections may affect the
chest (eg. bronchitis or
pneumonia), bladder (eg.
cystitis), sinuses (eg. sinusitis),
the ears (eg. otitis media) or the
skin.
AmoxyClav generichealth
tablets work by killing the
bacteria that cause these
infections. AmoxyClav
generichealth tablets will not
work against infections caused
by viruses such as colds or the
flu.
Your doctor may prescribe
AmoxyClav generichealth
tablets for another use. If you
want more information, ask your
doctor.
There is no evidence that
AmoxyClav generichealth
tablets are addictive.
BEFORE YOU TAKE
GENERICHEALTH 500/125 &
AMOXYCLAV
GENERICHEALTH 875/125
_WHEN YOU MUST

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – AMOXYCLAV GENERICHEALTH
500/125 AND AMOXYCLAV GENERICHEALTH 875/125
(AMOXICILLIN
(AS
TRIHYDRATE)
AND
CLAVULANIC
ACID
(AS
POTASSIUM
CLAVULANATE)) FILM COATED TABLET
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AmoxyClav generichealth 500/125 and AmoxyClav generichealth 875/125
(amoxicillin and clavulanic
acid
tablets)
are
combination
products
containing
the
semisynthetic
antibiotic,
amoxicillin
(as
trihydrate) and the β-lactamase inhibitor, potassium clavulanate (as
potassium salt of clavulanic acid).
AmoxyClav generichealth 875/125: Each film coated tablet contains 875
mg amoxicillin as the trihydrate
and 125 mg clavulanic acid as the potassium salt.
AmoxyClav generichealth 500/125: Each film coated tablet contains 500
mg amoxicillin as the trihydrate
and 125 mg clavulanic acid as the potassium salt.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AmoxyClav generichealth 875/125: A white elongated capsule shaped
film-coated tablet.
AmoxyClav generichealth 500/125: A white, oval shaped, film-coated
tablet with marking “CA625” on
one side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AmoxyClav generichealth 500/125 and AmoxyClav generichealth 875/125
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 amoxicillin and clavulanic
acid tablets. However, when there
AmoxyClav generichealth 500/1