Adverse reactions : תופעות לוואי

4.8     Undesirable effects
The most commonly reported adverse drug reactions are transient gastrointestinal disorders, vomiting, diarrhea, nausea and elevation of liver enzymes and serum creatinine. These effects are usually mild to moderate and transient or reversible at the end of treatment and therefore do not require discontinuation of treatment or dosage reduction.
In clinical trials and during therapeutic use the following undesirable effects were observed:
Very        Common       Unommon      Rare          Very rare    Not known common                                                           (cannot be Organ systems   (≥1/10)     (≥1/100 to   (≥1/1,000 to (≥1/10,000    (< 1/10,000) estimated from <1/10)       <1/100)      to                         the available data) < 1/1,000)
Immune                                                            Stevens system                                                            Johnson disorders                                                         Syndrome 
Blood and                                                        Thrombo- lymphatic                                                        cytopenia system disorders



6/8
Keratitis,
Eye disorders                                                                 keratopathy, acute scleritis (see section
4.4)
Gastrointestinal   Vomiting,     Anorexia      Abdominal disorders          diarrhea,                   pain nausea

Hepatobiliary      Increase in disorders          liver enzymes
(AST, ALT,
AP)

Renal and                        Increase of urinary                          BUN and disorders                        creatinine


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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