AUGMENTIN (rest of pamphlet)

AUGMENTIN

Adverse Reactions

Data from large clinical trials were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e., those occurring at <1/10,000) were mainly determined using 
post-marketing data and refer to a reporting rate rather than a true frequency. 
The following convention has been used for the classification of frequency :-

very common >1/10

common >1/100 and <1/10

uncommon >1/1 000 and <1/100 rare >1/10,000 and <1/1000 very rare <1/10,000.

Infections and infestations 
Common Mucocutaneous candidiasis

Blood and lymphatic system disorders

Rare Reversible leucopenia (including’heutropenia) and thrombocytopenia 
Very rare Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (see Warnings and Precautions). 
Immune system disorders 
Very rare Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity 
vasculitis

Nervous system disorders

Uncommon Dizziness, headache

Very rare Reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders 
Adults: 
Very common Diarrhoea

Common Nausea, vomiting

Children:

Diarrhoea, nausea, vomiting

Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking AUGMEN TIN at the start of a meal. 
Uncommon Indigestion 
Very rare Antibiotic-associated colitis (including pseuclomembranous colitis and haemorrhagic colitis). 
Black hairy tongue

Hepatobiliary disorders 
Uncommon A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown. 
Very rare Hepatitis and cholestatic jaundice. These events have been noted with other pen icillins and 
cephalosporins. 
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment, These events have been very rarely reported in children. Signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects. 
Skin and subcutaneous tissue disorders 
Uncommon Skin rash, pruritus, urticaria 
Rare Erythema multiforme 
Very rare Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalised exanthemous pustulosis (AGEP) 
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued. 
Renal and urinary disorders 
Very rare Interstitial nephritls, crystalluria (see Overdose) Overdose Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Gastrointestinal symptoms may be treated symptomatically with attention to the water electrolyte balance. 
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Warnings and Precautions). 
AUGMENTIN can be removed from the circulation by haemodialysis. 
Pharmacodynamics 
Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in AUGMENTIN anticipates this defence mechanism by blocking the 13-lactamase enzymes, thus rendering the organisms susceptible to amoxicillin’s rapid bactericidal effect at concentrations readily attainable in the body. Clavulanate by itself has little antibacterial activity; however, in association with amoxlcillin as AUGMEN TIN it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.

AUGMENTIN is bactericidal to a wide range of organisms including: 
Gram-positive Aerobes: Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyo genes, Streptococcus viridans, * Staphylococcus aumus, *coagulase negative staphylococci (including Staphylococcus epidermidis), Co,ynebactenum species, Bacillus anthracis, Listeria monocytogenes. Anaerobes: Clostridium species, Peptococcus species, Peptostreptococcus. 
Gram-negative 
Aerobes: °Haemophilus influenzae, *Eschenchia coli *Proteus mirabilis, *pmteus vulgaris, *Klebsiella species, *Moraxel!a catarrhalis, *Salmonella species, *Shigella species, Bordetella pertussis, Brucella species, *Neissena gonorrhoeae, Neisseria meningitidis, Vibno cholerae, Pasteurella multocida. Anaerobes: *Bactemides spp. including B. fragilis. * including -lactamase producing strains resistant to ampicillin and amoxicillin. 
Special Precautions for Storage 
AUGMEN TIN tablets should be stored in un-opened, original packs in a dry place below 25°C. 
Version number:GDSOI7IIPIO6 
Date of issue: 14 March 2007 
AUGMENTIN is a trademark of the GlaxoSmithKline group of companies 
CP555102)SB KEEP ALL MEDICAMENTS OUT OF THE REACH OF CHILDREN Manufactured by: 
Medical Union Pharmaceuticals, MW Abu-Sultan, Ismailla, Egypt. 
For: GlaxoSmithKline S.A.E, 
El Salam City, Cairo, A.R.E 
Under licence from 
the GlaxoSmithKllne group of companies

— Common 
All populations: 
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VGIaxoSmthKline