NASOBEC ALLERGY 50 Microgram Nasal Spray Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BECLOMETASONE DIPROPIONATE

Available from:

Norton Waterford

INN (International Name):

BECLOMETASONE DIPROPIONATE

Dosage:

50 Microgram

Pharmaceutical form:

Nasal Spray Suspension

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2013-04-26

Patient Information leaflet

PRODUCT:
AMENDS:
APPROVAL:
SENIOR ARTWORK CO-ORDINATOR
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
NASOBEC ALLERGY 50MCG AQUEOUS NASAL 
SPRAY ALL TEI V2
20047
-
11-5-11
WA
1
148 X 210MM
ILLUSTRATOR CS3
LEAFLET
Body: Univers 8pt
Subhead: Univers bold 9pt
Main Header: Univers bold 
11pt
BLACK
PMS GREEN
SUPPLIER INSTRUCTIONS 
Artwork, text and content must NOT be altered. The only exceptions to
this are: bleeds, chokes, 
spreads or other adjustments required for print reproduction purposes
only. If you have any difficulties please contact the 
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Proof before final approval can be made.  
DESIGN DEPARTMENT 
Harlow
Date        
Signed
Date         
Signed
LAST AMEND:
NASOBEC™ ALLERGY
50 MICROGRAMS AQUEOUS 
NASAL SPRAY
BECLOMETASONE DIPROPIONATE 
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully before you 
start to take your medicine. It contains 
important information. 
If you are not sure about anything, or if you 
want to know more, ask your pharmacist.
Keep this leaflet safe, as you may want to 
read it again.
OVERSIGT OVER INDLÆGSSEDLEN:
WHAT IS IN YOUR MEDICINE 
Nasobec Allergy is a nasal spray, suspension. 
Each spray from the bottle contains:
•  50 micrograms of Beclometasone 
Dipropionate (active ingredient), and 
•  Phenylethyl alcohol, Benzalkonium 
Chloride, Polysorbate 80, Dispersible 
Cellulose, Dextrose Anhydrous and 
Purified Water (inactive ingredients). Your 
medicine may also contain Hydrochloric 
Acid to adjust the pH.
Each bottle of Nasobec Allergy contains 100 
metered sprays.
WHO MAKES YOUR MEDICINE
The manufacturer of Nasobec Allergy is IVAX 
Pharmaceuticals s.r.o., Ostravska 29, 74770 
Opava 9, Czech Republic and Norton 
Waterford T/A IVAX Pharmaceuticals Ireland, 
Unit 301, IDA Industrial Park, Cork Road, 
Waterford, Ireland.
The marketing authorisation holder is Norton 
Waterford T/A IVAX Pharmaceuticals Ireland, 
Industrial Park,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nasobec Allergy 50 Micrograms Aqueous Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg spray contains 50 micrograms beclometasone dipropionate.
Excipient: each spray contains 0.02mg benzalkonium chloride
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nasal spray, suspension.
A white opaque suspension, free from any visible matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nasobec Allergy 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.
Beclometasone Dipropionate has anti-inflammatory glucocorticoid properties.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Regular usage is essential for full therapeutic benefit. Nasobec Allergy 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:-
Two sprays twice daily into each nostril (400mcg/day) is the recommended initial dosage. It may be preferable for
some patients to administer a single spray into each nostril three or four times daily.
Once control of symptoms has been achieved move the dosage down to one spray twice daily into each nostril (200
micrograms beclometasone dipropionate per day).
The minimum dose should be used at which effective control of symptoms is maintained.
The total dosage for any 24 hour period should not normally exceed eight sprays, i.e. 400 micrograms of
beclometasone dipropionate.
If there is no response after 14 days of treatment, medical advice should be sought.
Nasobec Allergy is for nasal use only.
Do not use continu