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McNeil Healthcare (Ireland) Ltd
Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316
Summary of Product Characteristics last updated on medicines.ie: 03/01/2012
SPC Stugeron 25 mg

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 03/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   21-Dec-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2 changes:
Previous:
Each tablet contains 25mg cinnarizine.
For excipients, see section 6.1.

Current:
Each tablet contains 25mg cinnarizine.
Excipients: Contains Lactose monohydrate 158.8mg and Sucrose 15.0mg
For a full list of excipients, see section 6.1.



Section 6 changes:
Previous:
List of Excipients
Lactose
Maize starch
Sucrose
Talc
Cotton oil - hydrogenated
Pvidone K90

Current:
List of Excipients
Lactone Monohydrate
Maize starch
Sucrose
Talk
Cotton oil - hydrogenated
Povidone K90
Updated on 25/03/2010 and displayed until 03/01/2012
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:   12-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 6.3: Shelf life changed from 5 to 3 years
Updated on 22/02/2010 and displayed until 25/03/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   12-Feb-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.8: Revision based on safety data and presentation of ADRs in a single table.
Section 5.2: Update in line with CCDS
Section 5.3: Update in line with CCDS
Updated on 08/02/2010 and displayed until 22/02/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   06-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 5.1 -  ATC code added
Updated on 02/02/2010 and displayed until 08/02/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04-Dec-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 7 - Mew MAH - McNeil healthcare (Ire) Ltd.
Section 10 - updated to December 2009
Updated on 09/09/2008 and displayed until 02/02/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 7 – Marketing Authorisation Holder

Change of address

Change to section 10 – Date of revision of text

September 2008
Updated on 01/02/2006 and displayed until 09/09/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Updated on 20/12/2005 and displayed until 01/02/2006
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Updated on 22/11/2005 and displayed until 20/12/2005
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 05/06/2003 and displayed until 22/11/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Cinnarizine