Adverse reactions : תופעות לוואי

4.8     Undesirable effects
In clinical studies involving 248 participants, approximately 3% experienced adverse reactions while receiving 1g mesalazine Suppositories. The most commonly reported ADRs were headache, in approximately 0.8%, and gastrointestinal side effects (constipation in approximately 0.8%; nausea, vomiting and abdominal pain in 0.4% each).

The following side effects have been reported with the use of mesalazine: 

System Organ Class Frequency According to MedDRA convention

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 lymphatic                                                   (aplastic system                                                      anaemia, disorders                                                   agranulocytosis, pancytopenia,
neutropenia,
leukopenia,
thrombocytopenia)



Nervous system                 Headache,                peripheral neuropathy disorders                      dizziness



Cardiac disorders              Myocarditis,
pericarditis

Respiratory,
thoracic and                                            Allergic and fibrotic mediastinal                                             lung reactions disorders                                               (including dyspnoea, cough, bronchospasm,
alveolitis, pulmonary eosinophilia, lung infiltration,
pneumonitis)
Gastrointestinal               Abdominal pain,          Acute pancreatitis disorders                      diarrhoea, flatulence,
nausea, vomiting,
constipation

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


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

Musculoskeletal                                         Myalgia, arthralgia and connective tissue disorders



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

Changes in liver function parameters (increase in
Hepatobiliary                                                 transaminases and disorders                                                     parameters of cholestasis ), hepatitis,
cholestatic hepatitis



Reproductive                                                  Oligospermia system                                                        (reversible) 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/