Active Ingredient and Strength	FLUTICASONE FUROATE (MICRONISED) - 0.0275 MG/SPRAY
Dosage Form	SPRAY, SUSPENSION
Manufacturer and Country	GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS) - UNITED KINGDOM GLAXO WELLCOME S.A. - SPAIN
Registration Number	SIN13666P
Licence Holder	GLAXOSMITHKLINE PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	R01AD12

Indications

AVAMYS Nasal Spray is indicated for the treatment of the symptoms of allergic rhinitis in patients 2 years of age and older.

Dosage and Administration

AVAMYS Nasal Spray is for administration by the intranasal route only. For full therapeutic benefit regular scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration. It may take several days of treatment to achieve maximum benefit. An absence of an immediate effect should be explained to the patient (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Populations

For the treatment of seasonal allergic rhinitis and perennial allergic rhinitis:

Adults and Adolescents (12 years and older)

The recommended starting dosage is 2 sprays (27.5 micrograms per spray) in each nostril once daily (total daily dose, 110 micrograms).

Once adequate control of symptoms is achieved, dose reduction to 1 spray in each nostril once daily (total daily dose, 55 micrograms) may be effective for maintenance.

Children (2 to 11 years)

The recommended starting dosage is 1 spray (27.5 micrograms per spray) in each nostril once daily (total daily dose, 55 micrograms).

Patients not adequately responding to 1 spray in each nostril once daily (total daily dose, 55 micrograms) may use 2 sprays in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to 1 spray in each nostril once daily (total daily dose, 55 micrograms) is recommended.

Children (under 2 years of age)

There are no data to recommend use of intranasal fluticasone furoate for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age.

Elderly

No dosage adjustment required (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dosage adjustment required (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dosage adjustment is required in patients with hepatic impairment (see Warnings and Precautions, and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

AVAMYS Nasal Spray is contraindicated in patients with hypersensitivity to any of the ingredients.