Adverse reactions : תופעות לוואי

4.8      Undesirable effects
The adverse effects are listed below, by system organ class and frequency. Frequencies are defined as: 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) or very rare (<1/10,000), unknown (cannot be calculated from available data).
Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.
System Organ Class                          Adverse Reactions                 Frequency Immune system disorders             Hypersensitivity reaction                Very rare (angioedema, rash, pruritus)
Nervous system disorders            Headache                                 Common Eye disorders                       Transient loss of vision                 Very rare Cardiac disorders                   Irregular heart rate and                 Very rare increased heart rate
Respiratory, thoracic and           Nasal dryness or discomforn              Common mediastinal disorders
Epistaxis                                Uncommon
Apnea in children and                    Very rare newborns
Gastrointestinal disorders          Nausea                                   Common General disorders and               Burning at the application               Common administrations site                site conditions
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/
Additionally, please also report to GSK Israel (il.safety@gsk.com)