Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects are listed under headings of frequency using the following categories:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Adult population:
The undesirable effects listed in the table below have been reported during clinical trials (including 600 adult patients) and post-marketing use. Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system:

System Organ Class                          Adverse reactions Immune system disorders

Very rare                                   Hypersensitivity reactions (pruritus, rash, face oedema, Quincke oedema, urticaria,
anaphylactic shock)
Not known                                   Erythema
Metabolism and Nutrition Disorders

Not known                                   Electrolytes disorders (hyponatremia, hypokalaemia) and/or dehydration,
especially in elderly patients
Gastrointestinal disorders

Common                                      Abdominal pain and/ or distension Diarrhea
Nausea
Uncommon                                    Vomiting
Urgency to defecate
Fecal incontinence
Paediatric population:
The undesirable effects listed in the table below have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use.
As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system:

System Organ Class                          Adverse reactions Immune system disorders
Not known                                   Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash,
pruritus)

Gastrointestinal disorders
Common                                      Abdominal pain Diarrhea*
Uncommon                                    Vomiting
Bloating
Nausea
* Diarrhea may cause perianal soreness

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 by using an online form https://sideeffects.health.gov.il/