Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Tabulated list of adverse reactions
The following definitions apply to the incidence of undesirable effects: 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); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Table 1 Adverse Drug Reactions (ADR) by System Organ Class (SOC) and Frequency ** based on the frequency reported in clinical trials
*** rare in children
Occasionally, signs or symptoms of systemic glucocorticosteroid-side effects may occur with inhaled glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity (see section 4.4).
Description of selected adverse reactions
The candida infection in the oropharynx is due to drug deposition. Advising the patient to rinse the mouth out with water after each dosing will minimise the risk.
As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases (see Section 4.4).
In placebo-controlled studies, cataract was also uncommonly reported in the placebo group.
Clinical trials with 13119 patients on inhaled budesonide and 7278 patients on placebo have been pooled. The frequency of anxiety was 0.52% on inhaled budesonide and 0.63% on placebo; that of depression was 0.67% on inhaled budesonide and 1.15% on placebo.
  Paediatric population
Due to the risk of growth retardation in the paediatric population, growth should be monitored as described in section   4.4.
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 an online form:
 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il