Adverse reactions : תופעות לוואי

Adverse Reactions
Data from large clinical trials were used to determine the frequency of adverse reactions.
The following convention has been used for the classification of frequency: - 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


Respiratory, thoracic and mediastinal disorders
Very Common: Epistaxis
Epistaxis was generally mild to moderate in intensity. In adults and adolescents, the incidence of epistaxis was higher in longer term use (more than six weeks) than in short term use (up to six weeks). In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between fluticasone furoate and placebo.
Common: Nasal ulceration


Children
Not known: Growth retardation
In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year (95% confidence interval: -0.48, -0.06 cm) in growth velocity was observed compared to placebo (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
Post Marketing Data
Immune system disorders
Rare: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Nervous system disorders
Common: Headache.
Respiratory, thoracic and mediastinal disorders
Uncommon: Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness.
Very rare: Nasal septum perforation


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).