Augmentin 125

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amoxicillin trihydrate 28.698 mg/mL equivalent to amoxycillin 25mg/mL; Potassium clavulanate 7.446 mg/mL equivalent to clavulanic acid 6.25mg/mL

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Amoxicillin trihydrate 28.698 mg/mL (=Amoxycillin 25 mg/mL)

Dosage:

125 mg/5mL

Pharmaceutical form:

Powder for oral suspension

Composition:

Active: Amoxicillin trihydrate 28.698 mg/mL equivalent to amoxycillin 25mg/mL Potassium clavulanate 7.446 mg/mL equivalent to clavulanic acid 6.25mg/mL Excipient: Aspartame Colloidal silicon dioxide Golden syrup flavour 52927 AP0551 Hydrated silica Hypromellose Orange flavour PHS-134215 Orange flavour SD653970 Raspberry flavour NN07943 Succinic acid Xanthan gum

Units in package:

Bottle, glass, Euro bottle, 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

SmithKline Beecham Pharmaceuticals Ltd

Therapeutic indications:

AUGMENTIN should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data. AUGMENTIN is indicated for the short term treatment of common bacterial infections in adults and children such as: Upper Respiratory Tract Infections (including ENT): e.g. tonsillitis, sinusitis, otitis media Lower Respiratory Tract Infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho pneumonia Genito-urinary Tract Infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections Skin and Soft Tissue Infections Bone and Joint Infections: e.g. osteomyelitis Other Infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis, post-surgical infections Susceptibility to AUGMENTIN will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. Infections caused by amoxicillin susceptible organisms are amenable to AUGMENTIN treatment due to its amoxicillin content. Mixed infections caused by amoxicillin susceptible organism in conjunction with AUGMENTIN susceptible beta-lactamase-producing organisms may therefore be treated by AUGMENTIN.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, clear Ph Eur type III with CRC - 100 mL - 24 months from date of manufacture stored at or below 30°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1983-11-22

Patient Information leaflet

AUGMENTIN
1
AUGMENTIN POWDER FOR ORAL SUSPENSION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING AUGMENTIN?
AUGMENTIN contains the active ingredient potassium
clavulanate/amoxicillin trihydrate. AUGMENTIN is used for the short
term
treatment of infections in different parts of the body caused by
bacteria.
For more information, see Section 1. Why am I using AUGMENTIN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AUGMENTIN?
Do not use if you have ever had an allergic reaction to AUGMENTIN or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
AUGMENTIN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AUGMENTIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE AUGMENTIN?
•
The usual dose may depend on the type of infection and how severe it
is.
More instructions can be found in Section 4. How do I use AUGMENTIN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AUGMENTIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using AUGMENTIN.
•
Keep taking this medicine for the full time of treatment, even if you
begin to feel better after a few
days.
THINGS YOU
SHOULD NOT DO
•
Stop taking AUGMENTIN because you are feeling better, unless advised
by your doctor.
•
Give AUGMENTIN to anyone else, even if they have the same condition as
you.
•
Use AUGMENTIN to treat any other complaints unless your doctor tells
you to.
DRIVING OR USING
MACHINES
•
AUGMENTIN does not usually affect the ability to drive or operate
machinery.
LOOKING AFTER
YOUR MEDICINE
•
Keep the bottle ti

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
AUGMENTIN 125 mg/31.25 mg powder for oral suspension
AUGMENTIN FORTE 250 mg/62.5 mg powder for oral suspension
AUGMENTIN 500 mg/125 mg film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AUGMENTIN powder for oral suspension: When reconstituted, each 5 mL
contains
amoxicillin trihydrate equivalent to 125 mg amoxicillin and potassium
clavulanate
equivalent to 31.25 mg clavulanic acid.
AUGMENTIN FORTE powder for oral suspension: When reconstituted, each 5
mL
contains amoxicillin trihydrate equivalent to 250 mg amoxicillin and
potassium
clavulanate equivalent to 62.5 mg clavulanic acid.
AUGMENTIN tablets: Each film coated tablet contains amoxicillin
trihydrate
equivalent to 500 mg amoxicillin and potassium clavulanate equivalent
to 125 mg
clavulanic acid.
Excipients with known effect
AUGMENTIN and AUGMENTIN FORTE powder for oral suspension: contains 2.5
mg of aspartame per mL.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
AUGMENTIN: Powder for oral suspension. White to off-white powder.
AUGMENTIN FORTE: Powder for oral suspension. White to off-white
powder.
AUGMENTIN tablets: White to off white, oval shaped, film coated
tablets,
approximately 20 mm x 9.5 mm, engraved 'AC' with a score line on one
side and
plain on the other side. The score line is only to facilitate breaking
for ease of
swallowing and not to divide into equal doses.
4.1
THERAPEUTIC INDICATIONS
AUGMENTIN should be used in accordance with local official antibiotic
prescribing
guidelines and local susceptibility data.
AUGMENTIN is indicated for the short term treatment of common
bacterial infections
in adults and children such as:
UPPER RESPIRATORY TRACT INFECTIONS (INCLUDING ENT): e.g. tonsillitis,
sinusitis, otitis
media
2
LOWER RESPIRATORY TRACT INFECTIONS: e.g. acute exacerbation of chronic
obstructive
pulmonary disease (AECOPD)/acute exacerbations of chronic bronchitis
(AECB),
lobar and broncho-pneumonia
GENITO-URINARY TRACT INFECTIONS: e.g. cystitis,