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 to 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to 1/1000) very rare (1/10,000) and not known (frequency cannot be estimated from available data). In assigning adverse event frequencies, the background rates in placebo groups in clinical trials were not taken into account, since these rates were generally comparable to or higher than those in the active treatment group.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class
Adverse Event                     Frequency


Immune system              Hypersensitivity              Very rare (<1/10,000) disorders                  reactions,
anaphylaxis/ anaphylactic reactions,
bronchospasm, rash,
oedema of the face and mouth
Eye disorders              ***Glaucoma, raised           Very rare (<1/10,000) intraocular pressure,
Cataract

Vision, blurred               Not known (see section 4.4)
Respiratory, thoracic      Epistaxis                     Very common (≥1/10) and mediastinal disorders      *Nasal dryness, nasal         Common (≥1/100 to <1/10) irritation, throat dryness,
throat irritation
**Nasal septal                Very rare (<1/10,000) perforation
Nasal ulcers                  Not known


*As with other intranasal products dryness and irritation of the nose and throat, and epistaxis may occur.
**There have also been cases of nasal septal perforation following the use of intranasal corticosteroids.
***These events have been identified from spontaneous reports following prolonged treatment.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

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. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.health.g ov.il) or by email (adr@MOH.HEALTH.GOV.IL).
Additionally, you should also report to GSK Israel (il.safety@gsk.com).