It is used for the treatment of allergic rhinitis in adults, adolescents, and children over 6 years of age.
Active ingredient: Fluticasone furoate (micronized) – 27.5 mcg per dose.
Excipients: Anhydrous glucose, dispersed cellulose (sodium carmellose 11%), polysorbate 80, benzalkonium chloride solution, disodium edetate, purified water.
Symptomatic treatment of allergic rhinitis in adults, adolescents, and children aged 6 years and older.
Hypersensitivity to fluticasone furoate or any other component of the product.
Pregnancy: Data on the use of fluticasone furoate during pregnancy is insufficient. Animal studies with glucocorticoids have shown developmental abnormalities including cleft palate and intrauterine growth retardation. These findings are unlikely to be relevant in humans when used at recommended intranasal doses. Fluticasone furoate should be used during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus.
Lactation: It is unknown whether fluticasone furoate administered intranasally is excreted in human breast milk. The drug should be prescribed to breastfeeding mothers only if the benefit to the mother clearly outweighs the potential risk to the infant.
Fertility: No human data on fertility is available.
For intranasal use only.
Regular use is required to achieve the full therapeutic effect. Symptom relief may begin as early as 8 hours after the first dose. However, several days of use may be required to reach maximum effectiveness. Patients should be advised that symptom improvement is achieved through consistent use. The duration of treatment should be limited to the period of allergen exposure.
Adults and adolescents (12 years and older):
Recommended starting dose: 2 sprays in each nostril once daily (total daily dose 110 mcg).
Once adequate symptom control is achieved, the dose may be reduced to 1 spray in each nostril once daily (total daily dose 55 mcg) to maintain symptom control.
Dose titration to the lowest effective dose is recommended.
Children aged 6–11 years:
Recommended starting dose: 1 spray in each nostril once daily (total daily dose 55 mcg).
If symptom control is inadequate, the dose may be increased to 2 sprays in each nostril once daily (total daily dose 110 mcg), then reduced back to 1 spray once control is achieved.
Children under 6 years of age:
Safety and efficacy have not been established. Dosing recommendations cannot be made.
Elderly patients:
No dose adjustment required.
Patients with renal or hepatic impairment:
No dose adjustment required.
Store at a temperature not exceeding 30°C. Do not freeze. Do not refrigerate. Store in an upright position. Keep out of the reach of children.
