AMOXIL SUGAR FREE SYRUP amoxicillin 125 mg/5 mL (as trihydrate) powder for oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 28.7 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, powder for

Composition:

Excipient Ingredients: colloidal anhydrous silica; disodium edetate; xanthan gum; saccharin sodium; sodium benzoate; sorbitol; silicon dioxide; Flavour

Administration route:

Oral

Class:

Medicine Registered

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 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): E.coli (see Microbiology), P.mirabilis and S.faecalis. Gonorrhoea: N.gonorrhoeae (non-penicillinase producing). Prophylaxis of endocarditis: AMOXIL 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: White free flowing powder;

Authorization status:

Licence status A

Authorization date:

1991-08-14

Patient Information leaflet

AMOXIL PAEDIATRIC PREPARATIONS
1
AMOXIL PAEDIATRIC
PREPARATIONS
_Amoxicillin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you give AMOXIL to your
child.
This leaflet answers some common
questions about AMOXIL. It does
not contain all of the available
information.
It does not take the place of talking to
your child’s doctor or pharmacist.
All medicines have risks and
benefits. Sometimes new risks are
found even when a medicine has
been used for many years. Your
child’s doctor has weighed the
expected benefits of your child
taking AMOXIL against the risks
this medicine could have for your
child.
AMOXIL must be given to your
child as instructed. If you have any
concerns about this medicine, ask
your child’s doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT IS AMOXIL USED
FOR?
AMOXIL contains a penicillin called
amoxicillin as the active ingredient.
Amoxicillin belongs to the penicillin
group of antibiotics.
AMOXIL is used to treat a range of
infections caused by bacteria. These
may be infections of the chest
(pneumonia), tonsils (tonsillitis),
sinuses (sinusitis), inner ear (otitis
media), urinary and genital tract or
skin and fleshy tissues.
AMOXIL works by killing the
bacteria that cause these infections.
AMOXIL can also be used to prevent
infection.
Your child’s doctor may have
prescribed AMOXIL for another
reason.
There is no evidence that AMOXIL
is addictive.
BEFORE YOU GIVE
AMOXIL
_DO NOT GIVE AMOXIL IF: _
•
your child is allergic to penicillin
or similar types of antibiotics
such as cephalosporins. If your
child has ever had an allergic
reaction (such as a rash) when
taking an antibiotic, tell the
doctor before any AMOXIL is
given.
•
your child has ever had an
allergic reaction to amoxicillin or
any of the ingredients listed
toward the end of this leaflet.
(See "Ingredients")
•
the expiry date (EXP) printed on
the pack has passed.
•
the packaging is torn or shows
signs of tampering.
_TELL YOUR CH

Summary of Product characteristics

Amoxil-Product Information
1
AUSTRALIAN PRODUCT INFORMATION
AMOXIL (AMOXICILLIN TRIHYDRATE)
CAPSULES AND POWDER FOR ORAL LIQUID
1
NAME OF THE MEDICINE
Amoxicillin trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AMOXIL
250
and
500
mg capsule contains amoxicillin trihydrate equivalent to either 250
mg or 500 mg of amoxicillin
Each bottle of AMOXIL powder for oral liquid contains amoxicillin
trihydrate equivalent to 125
mg, 250 mg per 5 mL or 100 mg per 1 mL, of amoxicillin when
reconstituted.
Excipients with known effect: AMOXIL SUGAR FREE SYRUP and AMOXIL FORTE
SUGAR FREE
SYRUP - benzoates and saccharin. AMOXIL PAEDIATRIC DROPS - benzoates.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AMOXIL
250
AND
500
MG
CAPSULES:
250 MG: A size '2' hard gelatin capsule with yellow body and maroon
cap printed with 'AM250'
on cap and body in white ink linearly and containing white/off white
powder
500 MG: A size '0EL' hard gelatin capsule with yellow body and maroon
cap printed with 'AM500'
on cap and body in white ink linearly and containing white/off white
powder
AMOXIL
SUGAR
FREE
SYRUP AMOXICILLIN 125MG/5ML (AS TRIHYDRATE) POWDER FOR ORAL LIQUID
BOTTLE: White free flowing powder. Each 5 mL of the off-white
reconstituted oral suspension
contains amoxicillin trihydrate equivalent to amoxicillin 125mg.
AMOXIL
FORTE
SUGAR
FREE
SYRUP
AMOXICILLIN 250MG/5ML (AS TRIHYDRATE) POWDER FOR
ORAL LIQUID BOTTLE: White free flowing powder. Each 5 mL of the
off-white reconstituted oral
suspension contains amoxicillin trihydrate equivalent to amoxicillin
250mg.
AMOXIL PAEDIATRIC DROPS
AMOXICILLIN 100MG/ML (AS TRIHYDRATE) POWDER FOR ORAL LIQUID
BOTTLE: White free flowing powder. Each 1 ml of off-white
reconstituted oral suspension contains
amoxicillin trihydrate equivalent to Amoxicillin 1OOmg.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
It is indicated for the treatment of the following infections due to
susceptible strains of sensitive
organisms:
Amoxil-Product Information
2
Note: