Beclometasone Dipropionate Aqueous Nasal Spray, 50 micrograms per spray

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BECLOMETASONE DIPROPIONATE

Available from:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

ATC code:

R01AD01

INN (International Name):

BECLOMETASONE DIPROPIONATE 50 µg

Pharmaceutical form:

NASAL SPRAY, SOLUTION

Composition:

BECLOMETASONE DIPROPIONATE 50 µg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-09-28

Patient Information leaflet

 
COLOURS:
Black
PL: 4569/0326 
APPROVED TO PRINT:
Marketing
Registration
Production
Customer
Quality Assurance
Generics [UK] Limited, Design Department
Albany Gate, Darkes Lane, Potters Bar, Herts, EN6 1AG
CUSTOMER:
  ANY OLS
DESIGNER:
 Maria Toumazou
PRODUCT:
  Beclometasone Nasal Spray 50 mcg x 200's POM 
ITEM CODE:
  (BU-I) 302194
PHARMACODE:
  Pacific's
DIMENSIONS:

150 X 140 mm
PROOF NO & DATE:
  3  21/06/04
REVISION:
  BAN's to rINN's. Packed @ Pacific. To run in 
parallel with Inyx packing. Further text changes from MDSG.
SUPERSEDES: 
(BG-I) 301890
ARTWORK FOR SUBMISSION
KEEP ALL MEDICATION OUT OF THE REACH AND 
SIGHT OF CHILDREN. BEFORE YOU USE YOUR 
MEDICINE PLEASE READ THIS LEAFLET CAREFULLY. 
This leaflet contains a summary of the information about 
your medicine, Beclometasone Dipropionate Aqueous 
Nasal Spray 50 micrograms per spray.
YOUR MEDICINE
Your medicine is in the form of a nasal spray. Each dose 
contains 50 micrograms of the active ingredient 
Beclometasone Dipropionate. The nasal spray also contains 
Dextrose, Polysorbate 80, Microcrystalline Cellulose, 
Sodium Carboxymethyl Cellulose, Benzalkonium Chloride, 
Phenylethanol and Purified Water.
 The active ingredient in this medicine is Beclometasone 
 Dipropionate. This is the new name for Beclomethasone 
 Dipropionate. The ingredient itself has not changed.
This medicine is available in a brown glass bottle fitted 
with a white nozzle and provides you with approximately 
200 doses of drug.
HOW DOES YOUR MEDICINE WORK ?
Beclometasone Dipropionate is a steroid. It acts by 
reducing the inflammation in the lining of your nose which 
may be the cause of your sneezing, itchy, blocked or 
runny nose.
Product Licence Holder and Manufacturer: Generics [UK] 
Limited, Station Close, Potters Bar, Hertfords

Summary of Product characteristics

Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Category POM 

Beclometasone Dipropionate Aqueous Nasal Spray, 50 micrograms per
spray. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each spray contains: Beclometasone Dipropionate  
Ph. Eur., 50 micrograms 

3. PHARMACEUTICAL 
FORM 

Mechanical driven (atomising) spray for nasal use. 

CLINICAL PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 

Category POM 

Beclometasone Dipropionate Aqueous Nasal Spray is indicated for the
treatment and 
prevention of seasonal and perennial allergic rhinitis;
hayfever and vasomotor rhinitis.  The 
drug has a potent anti-inflammatory effect within the respiratory
tract at doses which are not 
systemically active. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Category POM 

Beclometasone Dipropionate Aqueous Nasal Spray for intranasal
administration only. 

Adults and children: 

There is insufficient clinical data at present to support the
recommended use of this product 
in children under the age of six. 

A dose range of 200 to 400 µg per day is recommended. The
recommended dosage for 
adults and children is two sprays into each nostril twice daily.
 Once control of symptoms 
has been achieved a single spray into each nostril twice a day may
be preferred.  However, 
the minimum dose should be used at which effective control of
symptoms is maintained. 

The total daily dose should not normally exceed eight sprays
(400 micrograms/day). 
Page 2 of 6 

For full therapeutic benefit regular use is essential.  Furthermore,
it should be explained to 
the patient that maximum relief may not be obtained with the first
few doses and that 
patients co-operation to comply with the regular dosage schedule
should be sought. 

4.3. CONTRA-INDICATIONS 

Beclometasone Dipropionate Aqueous Nasal Spray is_ _contra-indicated
in patients with a 
histo