AMOXYCILLIN GENERICHEALTH 250

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

13-04-2022

Public Assessment Report (PAR)

27-11-2017

Active ingredient:

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

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

amoxicillin trihydrate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: titanium dioxide; croscarmellose sodium; sodium lauryl sulfate; Gelatin; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; 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 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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. Respiratory (acute and chronic): H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, non-penicillinase producing; E. coli. Genitourinary tract (complicated and uncomplicated, acute and chronic): E.coli, 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 hard gelatin capsules imprinted with "RX 654" in black 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:

2013-07-05

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
AMOXYCILLIN GENERICHEALTH
(AMOXICILLIN TRIHYDRATE) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Amoxycillin generichealth.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
This leaflet was last updated on
the date at the end of this leaflet.
More recent information may be
available.
The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and
may contain important
information about the medicine
and its use of which you should
be aware.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Amoxycillin generichealth
against the benefits it is
expected to 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
GENERICHEALTH IS USED FOR
Amoxicillin is an antibiotic used
to treat infections in different
parts of the body caused by
bacteria. These may be
infections of the chest
(pneumonia), tonsils (tonsillitis),
sinuses (sinusitis), urinary and
genital tract, skin and fleshy
tissues.
Amoxicillin will not work against
infections caused by viruses
such as colds or the flu.
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.
Your doctor may have
prescribed Amoxycillin
generichealth for another
reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
AMOXYCILLIN GENERICHEALTH HAS
BEEN PRESCRIBED FOR YOU.
Amoxicillin is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
AMOXYCILLIN
GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AMOXYCILLIN
GENERICHEALTH 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 rea

Read the complete document

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – AMOXYCILLIN GENERICHEALTH
(AMOXICILLIN TRIHYDRATE) CAPSULES
1
NAME OF THE MEDICINE
Amoxicillin trihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxycillin generichealth capsules contain 250 mg or 500 mg
amoxicillin (as trihydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Amoxycillin generichealth 250 mg capsules: Yellow, hard gelatin
capsules imprinted with “RX 654” in
black on both cap and body.
Amoxycillin generichealth 500 mg capsules: Maroon/yellow, hard gelatin
capsules 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 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 _S. faecalis._
GONORRHOEA
_ _
_N. gonorrhoeae _(non-penicillinase producing).
PROPHYLAXIS OF ENDOCARDITIS
Amoxicillin 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.
4.2 DOSE AND METHOD OF ADMIN

Read the complete document