AUGMENTIN Film Coated Tablet 500/125 Base Milligrams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
Available from:
G & A Licensing Limited
Dosage:
500/125 Base Milligrams
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-11-06
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin 500 mg / 125 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amoxicillin Trihydrate equivalent to 500mg Amoxicillin and Potassium Clavulanate equivalent to
125mg clavulanic acid.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film coated Tablets
_Product imported from Greece and the UK:_
White, oval film-coated tablet with a score line on one side, 'A' on one side of the line and 'C' on the other and plain on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and
5.1):
o
Acute bacterial sinusitis (adequately diagnosed)
o
Acute otitis media
o
Acute exacerbations of chronic bronchitis (adequately diagnosed)
o
Community acquired pneumonia
o
Cystitis
o
Pyelonephritis
o
Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.
o
Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms
of an individual component.
The dose of Augmentin that is selected to treat an individual infection should take into account:
o
The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/01/2012_
_CRN 2092061_
_page number: 1_
o
The severity and the site of the i
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