Adverse reactions : תופעות לוואי

4.8           Undesirable effects
System Organ Class Frequency according to MedDRA convention


Common               Uncommon        Rare             Very rare              Not known 
(> 1/1,000 to   (> 1/10,000 to   (< 1/ 10,000)          (cannot be
(> 1/100 to <1/10)
<1/100)         <1/1,000)                               estimated from the available data)


Blood and                                                                Altered blood counts lymphatic system                                                         (aplastic anaemia, disorders                                                                agranulocytosis, pancytopenia,
neutropenia,
leukopenia,
thrombocytopenia)

Immune system                                                            Hypersensitivity disorders                                                                reactions such as allergic exanthema,
drug fever, lupus erythematosus syndrome, pancolitis


Nervous system          Headache                                Dizziness           Peripheral neuropathy disorders
Cardiac disorders                                               Myocarditis, pericarditis

Respiratory, thoracic                                                               Allergic and fibrotic lung and mediastinal                                                                     reactions (including disorders                                                                           dyspnoea, cough, bronchospasm,
alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis)

Gastro-intestinal                             Abdominal disorders                                     pain,
diarrhea,
dyspepsia,
flatulence,
nausea,
vomiting, acute pancreatitis
Hepatobiliary                                                   Cholestatic         Hepatitis disorders                                                       hepatitis Skin and                Rash,                                   Photosensitivity    Alopecia                     Drug reaction with subcutaneous            pruritus                                                                                 eosinophilia and tissue disorders                                                                                                 systemic symptoms (DRESS), Stevens-
Johnson syndrome
(SJS), toxic epidermal necrolysis
(TEN)
Musculoskeletal and                                             Arthralgia          Myalgia connective tissue disorders

Renal and urinary                                                                   Impairment of renal      Nephrolithiasis* disorders                                                                           function including acute and chronic interstitial nephritis and renal insufficiency

Reproductive                                                                        Oligospermia system and breast                                                                   (reversible)  disorders
General disorders                                               Asthenia, fatigue 
Investigations                                Changes in liver function parameters
(increase in transaminases and parameters of cholestasis),
changes in pancreatic enzymes
(lipase and amylase increased),
eosinophil count increased
* see section 4.4 for further information
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).

Photosensitivity
More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
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/