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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixonase 50 micrograms per metered dose, Aqueous nasal spray, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100mg metered dose contains 50 micrograms fluticasone propionate.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension.
_Product imported from Belgium:_
A white, opaque aqueous suspension.
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
4.3 CONTRAINDICATIONS
Fluticasone Propionate Aqueous Nasal Spray is contra-indicated in patients with a hypersensitivity to any of its
ingredients.
IRISH MEDICINES B
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