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                                           Altered blood counts lymphatic                                               (anaemia,aplastic anaemia, system                                                  agranulocytosis, disorders                                               neutropenia, leucopenia (incl. granulocytopenia),
pancytopenia,
thrombocytopenia, and eosinophilia (as part of an allergic reaction),
Immune system                                           Hypersensitivity reactions disorders                                               incl. anaphylactic reaction, Nervous system                                          Peripheral neuropathy disorders                             Dizziness
Headache

Cardiac                               Myocarditis* disorders                             Pericarditis*
Respiratory,                                            Allergic alveolitis, allergic thoracic and                                            and fibrotic lung reactions mediastinal                                             (incl. dyspnoea, coughing, disorders                                               bronchospasm, pulmonary eosinophilia, interstitial lung disease, pulmonary infiltration, pneumonitis)
Gastrointestinal   Diarrhoea,
acute disorders          abdominal pancreatitis*,
pain, nausea,
increased amylase   pancolitis vomiting,
(blood and/or flatulence urine),

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

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

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


General            Anal disorders and      discomfort
Administration     and irritation site conditions    at the
Drug fever 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/