APO-AMOXYCILLIN amoxicillin (as trihydrate) 250 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

25-06-2021

Summary of Product characteristics (SPC)

06-12-2021

Public Assessment Report (PAR)

27-11-2017

Active ingredient:

amoxicillin trihydrate, Quantity: 286.96 mg (Equivalent: amoxicillin, Qty 250 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amoxicillin trihydrate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: titanium dioxide; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium lauryl sulfate; Gelatin; croscarmellose sodium; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

20 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms. Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. Skin and skin structure: staphylococcus, non-penicillinase producing; Streptococcus; E. coli (see section 5.1 pharmacodynamic Properties - Microbiology). Respiratory (acute and chronic): H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, non-penicillinase producing; E. coli (see section 5.1 pharmacodynamic Properties - Microbiology). Genitourinary tract (complicated and uncomplicated, acute and chronic): E.coli (see section 5.1 pharmacodynamic Properties - Microbiology), P. mirabilis and Strep. faecalis. Gonorrhoea: N.gonorrhoeae (non-penicillinase producing). Prophylaxis of endocarditis: Amoxycillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

Product summary:

Visual Identification: yellow/yellow capsules with 'RX 654' in black ink on both cap and body; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-08-06

Patient Information leaflet

APO-AMOXYCILLIN CAPSULES
1
APO-AMOXYCILLIN
CAPSULES
_Amoxicillin (as trihydrate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE ASK YOUR
DOCTOR OR PHARMACIST IF YOU DO NOT
UNDERSTAND ANYTHING OR ARE
WORRIED ABOUT TAKING YOUR
MEDICINE.
This leaflet answers some common
questions about amoxicillin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on the medicine may be
available. Speak to your pharmacist
or doctor to obtain the most up to
date information on the medicine.
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.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Amoxycillin. It contains a penicillin
called amoxicillin (as trihydrate) as
the active ingredient.
It is an antibiotic which is used to
treat infections in different parts of
the body caused by bacteria.
Amoxicillin can also be used to
prevent infection.
Amoxicillin will not work against
infections caused by viruses such as
colds or the flu.
_HOW IT WORKS _
Amoxicillin is an antibiotic that
belongs to a group of medicines
called penicillins. These antibiotics
work by killing the bacteria that are
causing your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
amoxicillin for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery, but make sure
you know how it affects you before
driving.
_USE IN CHILDREN _
Amoxicillin

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- AMOXYCILLIN (AMOXICILLIN TRIHYDRATE)
CAPSULES
1
NAME OF THE MEDICINE
Amoxicillin (as amoxicillin
trihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg or 500 mg amoxicillin
(as trihydrate).
EXCIPIENT WITH KNOWN EFFECT
Contains phenylalanine and sulfites.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-AMOXYCILLIN 250 MG CAPSULES
Yellow/yellow, hard gelatin capsules (size no. 2), imprinted with
“RX 654” in black.
APO-AMOXYCILLIN 500 MG CAPSULES
Maroon/yellow, hard gelatin capsules (size no. 0), imprinted with
“RX 655” in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
It is indicated for the treatment of the following infections due to
susceptible strains of sensitive
organisms.
Note: Therapy should be guided by bacteriological studies, including
sensitivity tests, and by
clinical response. However, in emergency cases where the causative
organism has not been
identified, therapy with amoxicillin
may be useful. Clinical judgment will decide whether
combination with another antibiotic would provide a sufficiently broad
spectrum of activity
pending sensitivity test results.
SKIN AND SKIN STRUCTURE
Staphylococcus,
non-penicillinase
producing;
Streptococcus;
_E. _
_coli_
(see
section
5.1
PHARMACODYNAMIC PROPERTIES – MICROBIOLOGY).
RESPIRATORY (ACUTE AND CHRONIC)
_H. _
_influenzae_;
Streptococcus;
_Strep. _
_pneumoniae_;
Staphylococcus,
non-penicillinase
producing; _E. coli_ (see section 5.1 PHARMACODYNAMIC PROPERTIES –
MICROBIOLOGY).
GENITOURINARY TRACT (COMPLICATED AND UNCOMPLICATED, ACUTE AND
CHRONIC)_ _
_E. coli_ (see section 5.1 PHARMACODYNAMIC PROPERTIES –
MICROBIOLOGY), _P. mirabilis _and _S. _
_faecalis. _
2
GONORRHOEA
_N. gonorrhoeae_ (non-penicillinase producing).
PROPHYLAXIS OF ENDOCARDITIS
A
moxicillin may be used for the prophylaxis of bacterial endocarditis
in individuals at particular
risk, such as those with a prosthetic heart valve or those who have
previously had en

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