Alphamox 500 capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 575 mg (Equivalent: amoxicillin, Qty 500 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: sodium starch glycollate; purified talc; sodium lauryl sulfate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; brilliant blue FCF; purified water; iron oxide yellow; Gelatin

Administration route:

Oral

Units in package:

20 capsules, 28 capsules, 6 capsules, 30 capsules

Class:

Medicine Registered

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 (See Microbiology). Respiratory (Acute and Chronic) H. influenzae; Streptococcus; S. pneumoniae; staphylococcus, non-penicillinase producing; E. coli (see Microbiology). Genitourinary Tract (complicated and uncomplicated, Acute and Chronic) P. mirabilis; S. faecalis; E. coli (see Microbiology). Gonorrhoea N. gonorrhoea (non-penicillinase producing). Prophylaxis of Endocarditis Amoxycillin may be used for the prophylaxis of bacterial en

Product summary:

Visual Identification: Hard gelatin capsule of size "0el" having FEA ivory opaque body and FEG green opaque cap filled with white/almost white granular powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-09-20

Patient Information leaflet

ALPHAMOX
_amoxicillin (as trihydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALPHAMOX. 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. Your doctor has weighed
the risks of you taking ALPHAMOX
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALPHAMOX IS
USED FOR
ALPHAMOX contains the active
ingredient amoxicillin, which is an
antibiotic that belongs to a group of
medicines called penicillins.
ALPHAMOX is used to treat a range
of infections caused by bacteria.
These may be infections of the chest
(pneumonia), tonsils (tonsillitis),
sinuses (sinusitis), urinary and
genital tract, skin and fleshy tissues.
ALPHAMOX works by killing the
bacteria that causes these infections.
ALPHAMOX can also be used to
prevent endocarditis (heart infection)
in some people.
ALPHAMOX will not work against
infections caused by viruses, such as
colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ALPHAMOX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ALPHAMOX IF YOU
ARE ALLERGIC TO:
•
any medicine containing
amoxicillin
•
penicillin or any other similar
antibiotics such as cephalosporins
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is dam

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ALPHAMOX
®
_amoxicillin (as trihydrate) capsules or powder for oral liquid _
1
NAME OF THE MEDICINE
Amoxicillin (as trihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ALPHAMOX capsule contains amoxicillin trihydrate equivalent to
250 mg or 500 mg of amoxicillin.
Each bottle of ALPHAMOX powder for oral liquid contains amoxicillin
trihydrate equivalent to 125 mg or
250 mg per 5 mL of amoxicillin when reconstituted.
Excipients with known effect: powder for oral liquid – sorbitol,
aspartame and benzoates.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALPHAMOX CAPSULES
ALPHAMOX 250: hard gelatin capsule with ivory body and green cap Size
“2” filled with almost white
granular powder.
ALPHAMOX 500: hard gelatin capsule of size “0el” having FEA ivory
opaque body and FEG green opaque
cap filled with white/almost white granular powder.
ALPHAMOX POWDER FOR ORAL LIQUID
ALPHAMOX 125: white to off-white free flowing powder with a raspberry
odour. When reconstituted, it
readily produces a white to cream coloured completely homogenous
suspension.
ALPHAMOX 250: white to off-white free flowing powder with a raspberry
odour. When reconstituted, it
readily produces a white to cream coloured completely homogenous
suspension.
4
CLINICAL PARTICULARS
4.1
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 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