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               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                                      Very 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
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 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)7       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
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

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)