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), 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.

System Organ     Adverse Event                                 Frequency Class
Infections and   Candidiasis of the mouth and throat           Very Infestations                                                   Common 
Pneumonia (in COPD Patients)                  Common
Oesophageal candidiasis                       Rare
Immune           Hypersensitivity reactions with the
System           following manifestations:
Disorders
Cutaneous hypersensitivity reactions          Uncommon

Angioedema (mainly facial and                 Very Rare oropharyngeal oedema)
Respiratory symptoms (dyspnoea and/or        Very Rare bronchospasm)

Anaphylactic reactions                       Very Rare

Eye disorders      Vision, blurred (see section 4.4)            Not known Endocrine          Cushing’s syndrome, Cushingoid features,     Very Rare Disorders          adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract, glaucoma
Metabolism         Hyperglycaemia (see section 4.4 )            Very Rare and Nutrition
Disorders
Psychiatric        Anxiety, sleep disorders, behavioural        Very Rare Disorders          changes, including hyperactivity and irritability (predominantly in children)

Depression, aggression (predominantly in     Not known children)
Respiratory,       Hoarseness/dysphonia                         Common Thoracic and
Mediastinal        Paradoxical bronchospasm                     Very Rare Disorders
Epistaxis                                    Not known
Gastrointestinal   Dyspepsia                                    Very Rare Disorders
Skin &             Contusions                                   Common Subcutaneous
Tissue
Disorders
Musculoskelet      Arthralgia                                   Very Rare al and
Connective
Tissue
Disorders

Hoarseness and candidiasis of the mouth and throat (thrush) occurs in some patients. Such patients may find it helpful to rinse out their mouth with water after inhalation from the nebuliser. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with Flixotide Nebules.

Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation, decreased bone mineral density (see          4.4).
As with other inhalation therapy, paradoxical bronchospasm may occur (see          4.4). This should be treated immediately with a fast acting inhaled bronchodilators. Flixotide Nebules should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.


There was an increased reporting of pneumonia in studies of patients with COPD receiving FLIXOTIDE 500 micrograms. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap.

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, you should also report to GSK Israel (il.safety@gsk.com).