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Allen & Hanburys Ltd
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 18/11/2011
SPC Flixonase Nasule Drops

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

Updated on 18/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section

Summary of change

4.4

warnings for specific examples of psychiatric and other systemic ADRs at high doses of intranasal CS and particularly in children have been included.

4.8

a warning that systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

10.

Updated with new date of revision of text – 15 November 2011
Updated on 19/06/2009 and displayed until 18/11/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 Section 1 - Change of units from "milligrammes/millilitre" to "mg/ml"

Section 2 - Change of units from "milligrammes/millilitre" to "mg/ml" Correction of excipient reference

Section 4.7 - "Not applicable" changed to "Not relevant"

Section 4.8 - MedDRA classification and frequecies applied

Section 6.2 - "None reported" changed to "Not applicable"

Section 6.6 - "No special requirements" added

Section 10 - Date of revision updated
Updated on 30/03/2009 and displayed until 19/06/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1 - Change of units from "milligrammes/millilitre" to "mg/ml"


Section 2 - Change of units from "milligrammes/millilitre" to "mg/ml" Correction of excipient reference

 

Section 4.7 - "Not applicable" changed to "Not relevant"


Section 4.8 - MedDRA classification and frequecies applied


Section 6.2 - "None reported" changed to "Not applicable"


Section 6.6 - "No special requirements" added


Section 10 - Date of revision updated
Updated on 21/02/2005 and displayed until 30/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 12/02/2004 and displayed until 21/02/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 09/02/2004 and displayed until 12/02/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/04/2002 and displayed until 09/02/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/08/2001 and displayed until 11/04/2002
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 21/11/2000 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 08/11/1999 and displayed until 21/11/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
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