NASOBEC AQUEOUS 50 Microgram Nasal Spray Suspension

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

BECLOMETASONE DIPROPIONATE

Tilgjengelig fra:

Norton Waterford

ATC-kode:

R01AD01

INN (International Name):

BECLOMETASONE DIPROPIONATE

Dosering :

50 Microgram

Legemiddelform:

Nasal Spray Suspension

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Glucocorticoids

Autorisasjon status:

Authorised

Autorisasjon dato:

1999-03-04

Informasjon til brukeren

PRODUCT
:
AMENDS:
APPROVAL:
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT

Harlow
Signed
Signed
30137
NASOBEC 50 MCG AQUEOUS NASAL 
SPRAY ALL, (POM) TEL V2
4-9-13
148x245 mm
2
10-1-14
YA
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NASOBEC
TM
 50 MICROGRAMS 
AQUEOUS NASAL SPRAY
BECLOMETASONE DIPROPIONATE
PACKAGE LEAFLET: INFORMATION 
FOR THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU 
START USING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
•  Keep this leafl et. You may need to read it 
again.
•  If you have any further questions, ask your 
doctor or pharmacist.
•  This medicine has been prescribed for you 
only. Do not pass it on to others. It may 
harm them, even if their signs of illness are 
the same as yours.
•  If you get any side effects, talk to your 
doctor or pharmacist. This includes any 
possible side effects not listed in this 
leafl et. See section 4.
 IN THIS LEAFLET:
1.  WHAT NASOBEC IS AND WHAT IT IS USED FOR
2.  
WHAT YOU NEED TO KNOW BEFORE YOU USE 
NASOBEC 
3.  HOW TO USE NASOBEC 
4.  POSSIBLE SIDE EFFECTS
5.  HOW TO STORE NASOBEC 
6.  
CONTENTS OF THE PACK AND OTHER INFORMATION
   WHAT NASOBEC IS AND WHAT IT 
IS USED FOR
Nasobec contains beclometasone 
dipropionate, which belongs to a group of 
medicines called corticosteroids. Your 
medicine has anti-infl ammatory properties. 
Nasobec is used to prevent and treat: 
• Infl ammation in the linin

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nasobec 50 Micrograms Aqueous Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg spray contains 50 micrograms beclometasone dipropionate.
Excipients: contains Benzalkonium Chloride Solution 0.02 microlitres
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
For the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever and vasomotor rhinitis.
Nasobec is indicated in adults and children aged six years and over.
Nasobec can significantly delay the recurrence of nasal polyps after nasal polypectomy. Where polyps do recur,
Nasobec can suppress their increase in size.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children over six years old_: Two sprays twice daily into each nostril (400 mcg/day) is the recommended
dosage. It may be preferable for some patients to administer a single spray into each nostril three or four times daily.
Once control has been established it may be possible to maintain control with fewer sprays. Dosage should be adjusted
in each individual case to the lowest dose that achieves effective control of the symptoms.
The maximum daily dose of 400 mcg (eight sprays) should not normally be exceeded.
It should be made clear to patients that full therapeutic benefit will only be achieved after a few days treatment.
_Elderly_: Dosage as for adults.
_Paediatric population:_
The safety and efficacy of Nasobec in children aged less than six years old has not been established.
Method of administration
For administration by the intranasal route only.
HEALTH PRODUCTS REGULATORY AUTHORITY
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