AMOXYCILLIN SANDOZ amoxicillin 500mg (as trihydrate) capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate (Equivalent: amoxicillin, Qty mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; iron oxide yellow; titanium dioxide; Gelatin

Administration route:

Oral

Units in package:

28, 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 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. RESPIRATORY TRACT INFECTIONS (Acute and chronic): H, influenzae; Streptococcus; S. pneumoniae; Staphylococcus, non-pencillinase producing; E. coli (see Microbiology). UROGENITAL INFECTIONS (Complicated and uncomplicated, acute and chronic): E, coli (see Microbiology); P. mirabilis; S. faecalis. GONORRHOEA (N.gonorrhoeae, non-penicillinase producing). SKIN AND SKIN STRUCTURE INFECTIONS: Staphylococcus, non-penicillinase producing; Streptococcus; E. coli (see Microbiology). 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. Infections caused by pathogens with established penicillin G susceptibility should preferentially be treated with penicillin G.

Product summary:

Visual Identification: Yellow, opaque, hard gelatin capsules, size no. 0 (length approx. 21.5mm, diameter approx 7.5mm); 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:

1998-02-25

Patient Information leaflet

AMOXYCILLIN SANDOZ
®
1
AMOXYCILLIN
SANDOZ
®
_Amoxicillin Trihydrate capsules and suspension _
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.
Amoxycillin Sandoz is an antibiotic
used to treat infections in different
parts of the body caused by bacteria.
Amoxycillin Sandoz belongs to a
group of antibiotics called
penicillins. These antibiotics work by
killing the bacteria that are causing
your infection.
This medicine can also be used to
prevent certain 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.
Some of the symptoms of an
allergic reaction may include
asthma, wheezing, shortness of
breath, swelling of the face, lips
or tongue whi

Summary of Product characteristics

190205-Amoxycillin Sandoz capsule and Suspensions-pi
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
AMOXYCILLIN SANDOZ
®
(AMOXICILLIN TRIHYDRATE) 250/500 MG
CAPSULES, 125/250 MG/5 ML SUSPENSIONS
1
NAME OF THE MEDICINE
Amoxicillin trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Amoxicillin trihydrate
Amoxycillin Sandoz
®
Powder for Suspension contains 125 mg/5 mL or 250 mg/5 mL
amoxicillin (as trihydrate).
Each Amoxycillin Sandoz
®
Capsules contains 250 mg or 500 mg amoxicillin (as 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
®
Powder for Suspension is a white to slightly yellowish powder.
Amoxycillin Sandoz
®
Capsules are white to cream powder in an opaque yellow hard gelatin
capsule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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. Amoxicillin alone or in combination with another antibiotic,
may be used in an
emergency where the causative has not been identified.
•
Respiratory tract infections (acute and chronic):
_H. influenzae; _
Streptococcus;
_S. _
_pneumoniae; _
Staphylococcus, nonpenicillinase producing;
_E. coli_
(see Section 5.1
Pharmacodynamic properties/ Mechanism of action/ Microbiology).
•
Urogenital infections (complicated and uncomplicated, acute and
chronic):
_E. coli _
(see
Section 5.1 Pharmacodynamic properties/ Mechanism of action/
Microbiology),
_P. _
_mirabilis and Strep. faecalis. _
•
Gonorrhoea:
_N. gonorrhoea _
(nonpencillinase producing).
_ _
•
Skin
and
skin
structure
infections:
Staphylococcus,
nonpenicillinase
producing;
Streptococcus;
_E. coli_
(see Section 5.1 Pharmacodynamic properties/ Mechanism of
action/ Microbiology).
_ _
•
Prophylaxis of endocarditis: Amoxicillin may be used for the
prophyla