Adverse reactions : תופעות לוואי

4.8      Undesirable effects
Summary of the safety profile
The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, and rash. Hypersensitivity reactions and drug fever may occasionally occur, and severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see section 4.4).
Following rectal administration local reactions such as pruritis, rectal discomfort and urge may occur.


Frequency of adverse effects, based on clinical trials and reports from post-marketing surveillance

Not known (cannot
Common
Rare                                     be estimated from
≥1/100 to <                              Very rare
SOC                             ≥1/10,000 to ≤                              the available data).
1/10                                  ≤ 1/10,000
1/1,000

Blood and the lymphatic                                               altered blood counts system                                                  (anaemia, aplastic disorders                                               anaemia,
agranulocytosis,
neutropenia,
leukopenia (incl.
granulocytopenia) pancytopenia,
thrombocytopenia,
and eosinophilia (as
part of an allergic reaction)
Immune system                                        Hypersensitivity disorders                                            reactions incl.
anaphylactic reaction

Nervous system     Headache      dizziness           Peripheral disorders                                            neuropathy

Cardiac                          Myocarditis* disorders                        Pericarditis*
Respiratory,                                         Allergic alveolitis thoracic and                                         allergic and fibrotic mediastinal                                          lung reactions (incl.
disorders                                            dyspnoea, coughing, bronchospasm,
pulmonary eosinophilia,
interstitial lung disease, pulmonary infiltration,
pneumonitis)
Gastrointestinal   Diarrhoea,    acute disorders          Abdominal     pancreatitis*       Pancolitis pain,         Increased amylase
Nausea,       (blood and/or
Vomiting,     urine)
Flatulence

Hepato-biliary                                       Increased liver disorders                                            enzymes,
cholestasis parameters and bilirubin,
hepatotoxicity (incl.
hepatitis*,
cholestatic hepatitis,
cirrhosis, hepatic failure)
Skin and           Rash (incl.                       Alopecia                 Stevens-Johnson subcutaneous       urticaria,                        (reversible),            Syndrome tissue disorders   erythematous                      dermatitis allergic,     (SJS)/Toxic rash)        Photosensitivity**   erythema                 epidermal necrolysis multiforme,              (TEN)
Drug Reaction with
Eosinophilia and
Systemic Symptoms
(DRESS)


Musculoskeletal                                              Myalgia, arthralgia, connective                                                   lupus tissue and bone                                              erythematosus-like disorders                                                    syndrome 

Renal and                                                    renal function           Nephrolithiasis*** urinary                                                      impairment **** disorders                                                    (incl. interstitial      urine nephritis (acute and     discolouration*** chronic)*, nephrotic syndrome, renal insufficiency and
Reproductive                                                 Oligospermia system                                                       (reversible) disorders


General              Anal                                    Drug fever disorders and        discomfort administration       and irritation site conditions      at the application site, pruritus
(anal), rectal tenesmus

(* ) The mechanism of mesalazine induced myo- and pericarditis, pancreatitis, nephritis and hepatitis is unknown, but it might be of allergic origin.
(**) Photosensitivity: More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
(***) see section 4.4 for further information.
(****) Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.

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.
Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/