Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE MONOHYDRATE
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
50 Mcg/Dose
Nasal Spray Suspension
1999-09-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beconase Hayfever nasal spray 50 micrograms per spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg spray contains beclometasone dipropionate monohydrate equivalent to 50 micrograms Beclometasone Dipropionate Ph.Eur. Excipients: Each 100 mg spray contains benzalkonium chloride solution equivalent to benzalkonium chloride 20 micrograms. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, suspension An aqueous white opaque suspension in a plastic bottle fitted with a metering atomising pump and nasal applicator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Beconase Hayfever prevents and relieves nasal congestion, sneezing and a runny, itchy nose due to hayfever and other seasonal allergic conditions. Once nasal congestion is cleared the pressure and pain around the eyes is also reduced. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Regular usage is essential for full therapeutic benefit. Beconase Hayfever quickly starts to bring relief and reduce swelling in the nose although it may take a few days to build up to its maximum effect. Adults 18 years of age and over: The recommended dose is two applications into each nostril twice daily. Total daily administration should not exceed 8 applications (400 mcg). If there is no response after 14 days of treatment, medical advice should be sought. Beconase Hayfever is for nasal use only. Do not use continuously for longer than 3 months without consulting your doctor. 4.3 CONTRAINDICATIONS Known hypersensitivity to Beconase Hayfever or any of its components. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/10/2010_ _CRN 2090290_ _page number: 1_ 4 Olvassa el a teljes dokumentumot