Adverse reactions : תופעות לוואי

4.8         Undesirable effects
Adverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports and not known (cannot be estimated from the available data). Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data. In assigning adverse event frequencies, the background rates in placebo groups were not taken into account.


System Organ Class                      Adverse Event                   Frequency 

Immune system               Hypersensitivity reactions with the       Very rare disorders                   following manifestations:


Cutaneous hypersensitivity reactions           Very rare
Angioedema (mainly facial and                  Very rare oropharyngeal oedema)
Respiratory symptoms (bronchospasm)            Very rare
Anaphylactic reactions                         Very rare

Nervous system,               Headache, unpleasant taste, unpleasant Common disorders                     smell


Eye disorders                 Glaucoma, raised intraocular pressure, Very rare cataract
These events have been identified from spontaneous reports following prolonged treatment.
Vision, blurred                       Not known (see section 4.4)


Respiratory,
Epistaxis                                      Very common
Thoracic &
Mediastinal disorders                      Nasal dryness, nasal irritation, throat        Common dryness, throat irritation
Nasal septal perforation                       Very rare

Nasal ulcers                                   Not known

As with other nasal sprays, unpleasant taste and smell and headache have been reported.
As with other nasal sprays, dryness and irritation of the nose and throat, and epistaxis have been reported.

Nasal ulceration and nasal septal perforation have been reported following the use of intranasal corticosteroids, usually when there has been previous nasal surgery.

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).