Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUTICASONE PROPIONATE
B & S Healthcare
50 Mcg/Acutuation
Nasal Spray Suspension
2008-01-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flixonase 50 micrograms per actuation, Aqueous nasal spray, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100mg actuation contains 50 microgram of fluticasone propionate. Excipients: Benzalkonium chloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, suspension. _Product imported from France and Portugal:_ A white, opaque aqueous suspension intended for intranasal administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluticasone Propionate Aqueous Nasal Spray is indicated for the prophylaxis and treatment of seasonal allergic rhinitis including hay fever, and perennial rhinitis. Fluticasone propionate has potent anti-inflammatory activity but when used topically on the nasal mucosa has no detectable systemic activity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fluticasone Propionate Aqueous Nasal Spray is for administration by the intranasal route only. _Adults and children over 12 years of age: _For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis: Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice daily may be required. The maximum daily dose should not exceed four sprays into each nostril. _ELDERLY PATIENTS:_ The normal adult dosage is applicable. _CHILDREN UNDER 12 YEARS OF AGE: _For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis in children aged 4-11 years:- One spray into each nostril once a day, preferably in the morning. In some cases one spray into each nostril twice daily may be required. The maximum daily dose should not exceed two sprays into each nostril. For full therapeutic benefit regular usage is essentia Read the complete document