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Safety

Safety and tolerability information

Contraindications 1-4

Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients  History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.

Special warnings and precautions for use 1-4

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted.

Undesirable effects 1-4

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting ,mucocutaneous candidosis.

This information does not contain all safety information. For a complete description of adverse events, special warnings and precautions, please consult the full SmPC before prescribing this medicine, which you can request from GSK or you can access from the Website of the Pharmaceutical Services of the Ministry of Health

References:

  1. SmPC Augmentin Tablets 1gr
  2. SmPC Augmentin Tablets 500/125 mg
  3. SmPC Augmentin suspension 457 mg/5 ml
  4. SmPC Augmentin ES 600 mg/42.9 mg/5 ml

Before prescribing please consult the full SPC which you can request from GSK or access on the website of the Pharmaceutical Services of the Ministry of Health

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