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Allen & Hanburys Ltd
Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 23/02/2011
SPC Beconase Aqueous Nasal Spray

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   07-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


 

 

 

SUMMARY OF SPC CHANGES

(HIGHLIGHTED IN RED)

 

1.                  NAME OF THE MEDICINAL PRODUCT

 

Beconase Aqueous 50 micrograms per metered dose Aqueous Nasal Spray Suspension

 

2.                  QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 100mg spray contains beclomethasone dipropionate monohydrate equivalent to 50 micrograms of beclomethasone dipropionate.

Excipients: Each 100mg spray contains 20 micrograms of benzalkonium chloride

 

For a full list of excipients, see section 6.1.

 

3.                  PHARMACEUTICAL FORM

 

Nasal spray, suspension (Nasal Spray).

An aqueous, white, opaque suspension.

 

4.4       Special Warnings and Special Precautions for Use

 

            ……………..etc

 

This product contains benzalkonium chloride which may cause nasal irritation.

 

           

6.4       Special Precautions for Storage

 

Do not store above 30°C. Do not refrigerate. Keep the bottle in the outer carton in order to protect from light.

 

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

           

            No special requirements Shake gently before use

 

 
Updated on 30/10/2008 and displayed until 23/02/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/05/2005 and displayed until 30/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 12/12/2003 and displayed until 10/05/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Updated on 03/06/2003 and displayed until 12/12/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Beclometasone Dipropionate Monohydrate