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
5
Cholestatic jaundice                              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
7
Crystalluria (including acute renal injury)       Not known

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 at the start of 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 may also report to GSK Israel (il.safety@gsk.com).