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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: 06/09/2011
SPC Becodisks 100mcg

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 06/09/2011 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:   23-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes description:

Section

Summary of change

4.4

Warnings for possible systemic effects which occur more rarely for example “a range of psychological and behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children)” have been added.

 

4.8

In line with warnings added to Section 4.4 – the adverse event terms “Depression, aggression (predominantly in children)” have been added with frequency “Not Known”

10.

Updated with new date of approval: 23 August 2011
Updated on 16/12/2010 and displayed until 06/09/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3: Reduce shelf life from 3 years to 2 years
Section 10: Date of approval added
Updated on 01/02/2006 and displayed until 16/12/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 11/01/2005 and displayed until 01/02/2006
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 26/10/2004 and displayed until 11/01/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 25/09/2003 and displayed until 26/10/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 6.1 - List of Excipients
Updated on 29/01/2003 and displayed until 25/09/2003
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 15/11/2002 and displayed until 29/01/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 31/10/2002 and displayed until 15/11/2002
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 18/03/2002 and displayed until 31/10/2002
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 11/08/2001 and displayed until 18/03/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/03/2000 and displayed until 11/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  beclometasone dipropionate