Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with Augmentin, sorted by MedDRA System Organ Class are listed below.

The following terminologies have been used in order to classify the occurrence of undesirable effects.
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Infections and infestations
Mucocutaneous candidosis                        Common
Overgrowth of non-susceptible organisms         Not known
Blood and lymphatic system disorders
Reversible leucopenia (including                Rare neutropenia)
Thrombocytopenia                                Rare
Reversible agranulocytosis                      Not known
Haemolytic anaemia                              Not known
Prolongation of bleeding time and               Not known prothrombin time1

Immune system disorders8
Angioneurotic oedema                          Not known
Anaphylaxis                                   Not known
Serum sickness-like syndrome                  Not known
Hypersensitivity vasculitis                   Not known

Nervous system disorders
Dizziness                                     Uncommon
Headache                                      Uncommon
Reversible hyperactivity                      Not known
Convulsions1                                  Not known
Aseptic meningitis                            Not known
Cardiac disorders
Kounis syndrome                               Not known

Gastrointestinal disorders
Diarrhoea                                     Common
Nausea2                                       Common
Vomiting                                      Common
Indigestion                                   Uncommon
Antibiotic-associated colitis3                Not known
Drug-induced enterocolitis syndrome           Not known
(DIES)
Pancreatitis acute                            Not known
Black hairy tongue                            Not known
Tooth discolouration9                         Not known

Hepatobiliary disorders
Rises in AST and/or ALT4                      Uncommon
Hepatitis5                                    Not known
Cholestatic jaundice5                         Not known
Skin and subcutaneous tissue disorders6
Skin rash                                     Uncommon
Pruritus                                      Uncommon
Urticaria                                     Uncommon
Erythema multiforme                           Rare
Stevens-Johnson syndrome                      Not known
Toxic epidermal necrolysis                    Not known
Bullous exfoliative-dermatitis                Not known
Acute generalised exanthemous pustulosis      Not known
(AGEP)1


Drug reaction with eosinophilia and            Not known systemic symptoms (DRESS)
Symmetrical drug-related intertriginous and    Not known flexural exanthema (SDRIFE) (baboon syndrome)
Linear IgA disease                             Not known

Renal and urinary disorders
Interstitial nephritis                         Not known
Crystalluria (including acute renal            Not known injury)7

1
See section 4.4
2
Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking amoxicillin/clavulanic acid with a meal.
3
Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4) 4
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.
5
These events have been noted with other penicillins and cephalosporins (see section 4.4).
6
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section 4.4).
7
See section 4.9
8
See sections 4.3 and 4.4
9
Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
Additionally, you should also report to GSK Israel (il.safety@gsk.com).