nately with decreasing renal function. The reduction in drug clearance is more pronounced for amoxicillin than for clavulanic acid, as a higher proportion of amoxicillin is excreted via the renal route. Doses in renal impairment must therefore prevent undue accumulation of amoxicillin while maintaining adequate levels of clavulanic acid (see section 4.2).
Hepatic impairment
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
5.3 Preclinical safety data
Nonclinical data reveal no special hazard for humans based on studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid demonstrate gastric irritancy and vomiting, and discoloured tongue.
Carcinogenicity studies have not been conducted with Augmentin or its components.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipient(s)
Xanthan gum (E415)
Hypromellose (E464)
Aspartame (E951)
Silicon dioxide
Silica colloidal anhydrous
Succinic acid
Raspberry dry flavour
Orange dry flavour 1
Orange dry flavour 2
Golden syrup dry flavour
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Dry powder: 2 Years
Reconstituted suspension according to directions: 7 days
Discard any unused suspension seven days after reconstitution.
6.4 Special precautions for storage
The dry powder: Do not store above 25°C. Store in the original container to protect from moisture.
Reconstituted suspension according to directions: Store between 2°C and 8°C. Do not freeze.
6.5 Nature and contents of container
Glass bottles with aluminium screw caps or a ROPP, internally lacquered closure, containing a Polymer (PVC or Polyolefin) liner, containing powder for reconstitution to 100 ml.
6.6 Special precautions for disposal and other handling
Check cap seal is intact before using. Shake bottle to loosen powder. Add volume of water (92 ml) invert and shake well.
Shake the bottle well before each dose.
7. MARKETING AUTHORISATION HOLDER
GlaxoSmithKline (Ireland) Limited,
Stonemasons Way,
Rathfarnham,
Dublin 16.
8. MARKETING AUTHORISATION NUMBER(S)
PA 1077/93/4
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28th July 1983/28th July 2008
10. DATE OF REVISION OF THE TEXT
November 2013
Link to this document from your website:
http://www.medicines.ie/medicine/2188/SPC/Augmentin+Paediatric+125mg+31.25mg+per+5ml+Powder+for+Oral
+Suspension/
