AMOXYCILLIN SANDOZ amoxicillin (as trihydrate) 1000 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 1148 mg (Equivalent: amoxicillin, Qty 1000 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; povidone; magnesium stearate; sodium starch glycollate type A; hypromellose; titanium dioxide; purified talc

Administration route:

Oral

Units in package:

2 tablets, 20 tablets, 100 tablets, 14 tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amoxycillin Sandoz is indicated in the treatment of acute exacerbation of chronic bronchitis. Notes: Therapy should be guided by bacteriologic studies including sensitivity tests and by clinical response. Amoxycillin alone or in combination with another antibiotic, may be used in an emergency where the causative agent has yet to be identified. Amoxycillin Sandoz 1000mg tablets have not been shown to be bioequivalent to the 500mg and 250mg capsule formulations given in equivalent doses. Therefore, Amoxycillin Sandoz 1000mg tablets and other forms of amoxycillin are not considered interchangeable. Infections caused by pathogens with established penicllin G susceptibility should preferentially be treated with penicillin G.

Product summary:

Visual Identification: Oval, biconvex white to cream coloured tablet, scored on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2004-02-03

Patient Information leaflet

AMOXYCILLIN SANDOZ
®
1
AMOXYCILLIN
SANDOZ
®
_Amoxicillin Trihydrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Amoxycillin Sandoz.
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 taking Amoxycillin
Sandoz 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 need to read it again.
WHAT AMOXYCILLIN
SANDOZ IS USED FOR
The name of your medicine is
Amoxycillin Sandoz. It contains the
active ingredient amoxicillin
trihydrate.
Amoxicillin is an antibiotic used in
the treatment of bacterial infections.
Amoxycillin Sandoz belongs to a
group of antibiotics called
penicillins. These antibiotics work by
killing the bacteria that are causing
your infection.
Amoxycillin Sandoz is used for the
treatment of chest infections.
Amoxycillin Sandoz will not work
against infections caused by viruses
such as colds or the flu.
Your doctor may have prescribed
Amoxycillin Sandoz for another
reason. Ask your doctor if you have
any questions about why
Amoxycillin Sandoz has been
prescribed for you.
Amoxycillin Sandoz is available only
with a doctor's prescription.
Amoxycillin Sandoz is not addictive.
BEFORE YOU TAKE
AMOXYCILLIN SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AMOXYCILLIN SANDOZ IF:

YOU HAVE AN ALLERGY TO
AMOXICILLIN, ANY OTHER
PENICILLINS OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET

YOU HAVE HAD A SERIOUS ALLERGIC
REACTION TO ANY Β-LACTAM
ANTIBIOTICS (E.G. PENICILLINS,
CEPHALOSPORINS CARBAPENEM OR
MONOBACTAM). THESE ARE
ANOTHER GROUP OF ANTIBIOTICS
SIMILAR TO PENICILLINS
You may have an increased
chance of being allergic to
Amoxycillin Sandoz if you are
allergic to cephalosporins.
Some of the symptoms of an
allergic reaction may include
wheezing, shortne

Summary of Product characteristics

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Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
AMOXYCILLIN SANDOZ
® (AMOXICILLIN TRIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Amoxycillin Sandoz 1000 mg tablet contains 1000 mg amoxicillin as
the trihydrate.
Amoxicillin trihydrate is a white or almost white, crystalline powder.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Amoxycillin Sandoz tablets are oval, biconvex, white to
cream-coloured, scored on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Amoxycillin Sandoz is indicated in the treatment of acute exacerbation
of chronic bronchitis.
_Notes: _
Therapy should be guided by bacteriologic studies including
sensitivity tests and by clinical
response. Amoxicillin alone or in combination with another antibiotic,
may be used in an
emergency where the causative agent has yet to be identified.
Amoxycillin Sandoz 1000 mg tablets have not been shown to be
bioequivalent to the 500 mg
and 250 mg capsule formulations given in equivalent doses. Therefore,
Amoxycillin Sandoz
1000 mg tablets and other forms of amoxicillin are not considered
interchangeable.
Infections
caused
by
pathogens
with
established
penicillin
G
susceptibility
should
preferentially be treated with penicillin G.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults:_
1000 mg twice daily.
Treatment should be continued for a minimum of 48 to 72 hours beyond
the time when patients
become asymptomatic or evidence of bacterial eradication has been
obtained.
Bacteriological and clinical appraisals may have to be continued for
several months following
cessation of treatment.
METHOD OF ADMINISTRATION
Amoxycillin Sandoz may be taken without regard to food.
DOSAGE ADJUSTMENT IN:

renal impairment
In renal impairment, the excretion of the antibiotic will be delayed,
and depending on the
degree of impairment, it may be necessary to reduce the total daily
dose.
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