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).

Table 1 Adverse Drug Reactions (ADR) by System Organ Class (SOC) and Frequency SOC                          Frequency     Adverse Drug Reaction

Infections and               Common        Oropharyngeal candidiasis infestations
Pneumonia (in COPD patients)

Immune system                Rare          Immediate and delayed hypersensitivity reactions* disorders                                  including rash, contact dermatitis, urticaria, angioedema and anaphylactic reaction

Endocrine disorders          Rare          Signs and symptoms of systemic corticosteroid effects, including adrenal suppression and growth retardation**

Psychiatric disorders        Uncommon      Anxiety

Depression

Rare          Psychomotor hyperactivity

Sleep disorders


Aggression
Behavioural changes (predominantly in children)

Nervous system               Uncommon      Tremor*** disorders

Eye disorders                Uncommon      Cataract
Vision, blurred (see also section 4.4)

Unknown       Glaucoma

Respiratory, thoracic        Common        Cough and mediastinal
Hoarseness
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disorders                                    Throat irritation

Rare           Bronchospasm

Dysphonia
Hoarseness***

Skin and subcutaneous         Rare           Bruising tissue disorders

Musculoskeletal and           Uncommon       Muscle spasm connective tissue disorders
*refer to Description of selected adverse reactions; facial skin irritation, below 
**refer to Paediatric population, below

*** 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).

Facial skin irritation, as an example of a hypersensitivity reaction, has occurred in some cases when a nebuliser with a face mask has been used. To prevent irritation, the facial skin should be washed with water after use of the face mask.
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.


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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