AMOXYCLAV GH 500/125 amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate,potassium clavulanate

Available from:

Sandoz Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Authorization status:

Registered

Patient Information leaflet

1412 AmoxyClav GH 500/125 and 875/125 CMI v5
Page 1 of 5
CONSUMER MEDICINE INFORMATION
AMOXYCLAV GH 500/125
AMOXYCLAV GH 875/125
_AMOXYCILLIN AND POTASSIUM CLAVULANATE TABLETS _
WHAT IS IN THIS LEAFLET
Please read this leaflet
carefully before you take
AmoxyClav GH tablets.
This leaflet answers some
common questions about
AmoxyClav GH tablets.
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. 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 GH
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 IS AMOXYCLAV GH
TABLETS USED FOR?
AmoxyClav GH tablets contain
two active ingredients. One of
these ingredients is a type of
penicillin called amoxycillin
and the other is potassium
clavulanate.
AmoxyClav GH tablets are used
for the short term treatment of
a wide range of infections
caused by bacteria. These
infections may affect the chest
(bronchitis or pneumonia),
bladder (cystitis), sinuses
(sinusitis), the ears (otitis
media) or the skin.
AmoxyClav GH tablets work by
killing the bacteria that cause
these infections. AmoxyClav
GH tablets will not work
against infections caused by
viruses such as colds or the flu.
Your doctor may prescribe
AmoxyClav GH tablets for
another
use. If you want more
information, ask your doctor.
There is no evidence that
AmoxyClav GH tablets are
addictive.
BEFORE YOU TAKE
AMOXYCLAV GH TABLETS
_ _
Do not take AmoxyClav GH
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 AmoxyClav GH
tablets. _The ingredients are _
_listed at the end of this _
_leaflet. _
_Some of the symptoms of an _
_allergic reaction may _
_include

Summary of Product characteristics

AmoxyClav GH PI
_ _
_Page 1 of 15 _
PRODUCT INFORMATION
AMOXYCLAV GH 875/125 AND AMOXYCLAV GH 500/125 TABLETS
amoxycillin (as trihydrate) and clavulanic acid (as potassium
clavulanate) tablets
NAME OF THE MEDICINE
AmoxyClav GH 875/125 and AmoxyClav GH 500/125 tablet preparations are
a combination
product containing amoxycillin trihydrate and potassium clavulanate.
_Chemical Name: _
Amoxycillin trihydrate
_(_
2
_S,_
5
_R,_
6
_R)_
-6-[(
_R_
)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
Potassium clavulanate
Potassium (
_Z_
)-(2
_R_
, 5
_R_
)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-
carboxylate
_Structural Formula: _
Amoxycillin trihydrate
Potassium clavulanate
_Molecular Formula: _
Amoxycillin Trihydrate
C
16
H
19
N
3
O
5
S, 3H
2
O
Potassium Clavulanate
C
8
H
8
KNO
5
_Molecular Weight: _
Amoxycillin Trihydrate
419.4
Potassium Clavulanate
237.3
_CAS Number: _
Amoxycillin Trihydrate
61336-70-7
Potassium Clavulanate
61177-45-5
AmoxyClav GH PI
_ _
_Page 2 of 15 _
DESCRIPTION
Amoxycillin trihydrate is white to almost white, crystalline powder,
slightly soluble in water and in
alcohol, practically insoluble in ether and in fatty oils. It
dissolves in dilute acids and dilute
solutions of alkali hydroxides.
Potassium clavulanate is white to almost white, crystalline powder,
hygroscopic, freely soluble in
water, slightly soluble in alcohol, and very slightly soluble in
acetone.
Each tablet contains the following ingredients:
_Active Ingredients: _
_ _
Amoxycillin
(as trihydrate)
Clavulanic acid
(as potassium clavulanate)
AmoxyClav GH 500 /125 tablets
500 mg
125 mg
AmoxyClav GH 875 /125tablets
875 mg
125 mg
_Inactive Ingredients: _
Magnesium stearate, purified talc, povidone, croscarmellose sodium,
microcrystalline cellulose,
triethyl citrate, ethylcellulose, sodium lauryl sulfate, cetyl
alcohol, hypromellose and titanium
dioxide.
_ _
AmoxyClav GH 875/125 tablets also contain silicon dioxide.
PHARMACOLOGY
_PHARMACOLOGICAL AC