Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of safety profile:
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with fluconazole treatment (see section
4.4).
The most frequently (≥1/100 to <1/10) reported adverse reactions are headache, abdominal pain, diarrhoea, nausea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased,
blood alkaline phosphatase increased and rash.

The following adverse reactions have been observed and reported during treatment with fluconazole with the following frequencies:
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).

System Organ Class      Common               Uncommon            Rare         Not Known Blood and the                                Anaemia         Agranulocytosis, lymphatic system                                             leukopenia, disorders                                                    thrombocytopeni a, neutropenia
Immune system                                                Anaphylaxis disorders
Metabolism and                               Decreased       Hypercholestero- nutrition disorders                          appetite        laemia,
hypertriglyceri- daemia,
hypokalemia
Psychiatric                                  Somnolenc disorders                                    e, insomnia
Nervous system          Headache             Seizures,       Tremor disorders                                    paraesthesia,
dizziness,
taste
Ear and labyrinth                            Vertigo disorders


Cardiac disorders                                                      Torsade de pointes (see section 4.4), QT prolongation
(see section 4.4)
Gastrointestinal         Abdominal                   Constipation disorders                pain,                       dyspepsia,
vomiting,                   flatulence, dry diarrhoea,                  mouth nausea
Hepatobiliary            Alanine                     Cholestasis       Hepatic failure disorders                aminotransferase            (see section      (see section 4.4), increased (see              4.4), jaundice    hepatocellular section 4.4),               (see section      necrosis (see aspartate                   4.4), bilirubin   section 4.4),
aminotransferase            increased (see    hepatitis (see increased (see              section 4.4)      section 4.4),
section 4.4),                                 hepatocellular blood alkaline                                damage (see phosphatase                                   section 4.4) increased (see section 4.4)

Skin and                 Rash (see                   Drug eruption*    Toxic epidermal      Drug reaction subcutaneous tissue      section 4.4)                (see section      necrolysis, (see     with disorders                                            4.4), urticaria   section 4.4),        eosinophilia (see section      Stevens-Johnson      and systemic symptoms
4.4), pruritus,   syndrome (see
(DRESS) increased         section 4.4),
sweating          acute generalised exanthematous- pustulosis (see section 4.4),
dermatitis exfoliative,
angioedema,
face oedema,
alopecia
Musculoskeletal and                                  Myalgia connective tissue disorders
General disorders                                    Fatigue,
and administration                                   malaise,
site conditions                                      asthenia, fever
* including Fixed Drug Eruption


      Paediatric population
The pattern and incidence of adverse reactions and laboratory abnormalities recorded during paediatric clinical trials are comparable to those seen in adults.

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
Side effects can also be reported to the following email: safety@trima.co.il