Adverse reactions : תופעות לוואי

4.8        Undesirable effects

The following undesirable effects have been observed after administration of mesalazine: 
Frequency According to MedDRA Convention
System Organ Class
Common          Rare                Very rare                        Not known (≥ 1/100;       (> 1/10,000;        (< 1/ 10,000)                    (cannot be estimated <1/10)          <1/1,000)                                            from the available data)
Blood and
Altered blood counts (aplastic lymphatic system anaemia,
disorders agranulocytosis, pancytopenia,
neutropenia, leukopenia,
thrombocytopenia)
Nervous system                              Headache,           peripheral neuropathy disorders                                   dizziness
Cardiac                                  Myocarditis,
disorders                                   Pericarditis


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


Gastrointestinal                          Abdominal pain, Acute pancreatitis disorders                                 diarrhoea,
flatulence, nausea,
vomiting,
constipation
Renal and                                                     Impairment of renal function       Nephrolithiasis* urinary disorders                                             including acute and chronic interstitial nephritis and renal insufficiency

Skin and                   Rash,          Photosensitivity    Alopecia                           Drug reaction subcutaneous tissue        pruritus                                                              with eosinophilia disorders                                                                                        and systemic symptoms
(DRESS), Stevens-
Johnson syndrome
(SJS), toxic epidermal necrolysis
(TEN)


Musculoskeletal                                               Myalgia, arthralgia and connective tissue disorders
Immune                                                        Hypersensitivity reactions such system disorders                                             as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis


Hepatobiliary                                                 Changes in liver function disorders                                                     parameters (increase in transaminases and cholestasis parameters), hepatitis,
cholestatic hepatitis
Reproductive                                                  Oligospermia (reversible) system disorders

* 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/