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) 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.

Infections and Infestations

Very common: Candidiasis of mouth and throat.
Candidiasis (thrush) of the mouth and throat occurs in some patients. Such patients may find it helpful to rinse out their mouth with water after using their medication. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Flixotide Inhaler.

Common:         Pneumonia (in COPD patients).

Rare:           Oesophageal candidiasis
Immune System Disorders

Hypersensitivity reactions with the following manifestations have been reported: 
Uncommon:       Cutaneous hypersensitivity reactions.

Very rare:      Angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (dyspnoea and/or bronchospasm) and anaphylactic reactions.

Eye Disorders

Not known:     Vision, blurred.
Very rare:     Cataract, glaucoma.


Endocrine Disorders
Possible systemic effects (see section 4.4) include:

Very rare:      Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density

Metabolism and Nutrition Disorders

Very rare:      Hyperglycaemia.
Psychiatric Disorders

Very rare:      Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children).

Not known:      Depression, aggression (predominantly in children)

Respiratory, Thoracic and Mediastinal Disorders
Common:         Hoarseness

In some patients inhaled fluticasone propionate may cause hoarseness. It may be helpful to rinse out the mouth with water immediately after inhalation.

Very rare:      Paradoxical bronchospasm (see section 4.4).

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator.
Fluticasone propionate should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.

Not known:      Epistaxis

Skin and Subcutaneous Tissue Disorders
Common:         Contusions

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).