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 (≥1/1000 to <1/100)
Rare (≥1/10000 to <1/1000)
Very rare (<1/10000)
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 neutropenia)     Rare
Thrombocytopenia                                  Rare
Reversible agranulocytosis                        Not known
Haemolytic anaemia                                Not known
Prolongation of bleeding time and                 Not known prothrombin time1

Immune system disorders9
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
Pancreatitis acute                             Not known
Black hairy tongue                             Not known
Tooth discolouration4                          Not known

Hepatobiliary disorders
Rises in AST and/or ALT5                       Uncommon
Hepatitis6                                     Not known
Cholestatic jaundice6                          Not known

Skin and subcutaneous tissue disorders 7
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 systemic   Not known 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 injury)8   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 with a meal.
3
Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4) 4
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.
5
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.
6
These events have been noted with other penicillins and cephalosporins (see section 4.4).
7
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section 4.4).
8
See section 4.9
9
See sections 4.3 and 4.4

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).