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Servier Laboratories Ireland Ltd
Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin,
Telephone: +353 1 663 8110
Fax: +353 1 663 8120
Summary of Product Characteristics last updated on medicines.ie: 08/12/2011
SPC Procoralan 5mg Tablets

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 08/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   30-Sep-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
In Section 7: Marketing Authorisation Holder

Change from

LES LABORATOIRES SERVIER

22, rue Garnier

92200 Neuilly-sur-Seine

France

to

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France
Updated on 05/09/2011 and displayed until 08/12/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   26-Aug-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
$0update of section 4.8 to include new adverse eventsreported during the post-marketing experience : $0$0 $0$0Skin and subcutaneous tissuedisorders:$0$0 urticaria, angioedema$0$0 $0$0General disorders andadministration site conditions: $0$0asthenia possibly related to bradycardia $0$0fatigue possibly related to bradycardia$0$0 $0$0* Frequency calculated fromclinical trials for adverse events detected from spontaneous report$0
Updated on 09/12/2010 and displayed until 05/09/2011
Reasons for adding or updating:
  • 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:   29-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


new adverse events reported during the post-marketing experience (frequency unknown). :

- rash, erythema, pruritis

- hypotension, malaise, syncope (possibly linked to bradycardia).

 

 
Updated on 23/11/2009 and displayed until 09/12/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   23-Oct-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
As a result of a type II variation submitted to and approved by the EMEA, as well as the results of the BEAUTIFUL trial, the SPC for Procoralan needs updating. The update concerns sections 4.1, 4.3, 4.4, 4.8 and 5.1 of the SPC, the labelling and the Package Leaflet. The results of a supporting large safety study, Beautiful, are also introduced in section 5.1.
Updated on 06/08/2009 and displayed until 23/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   18-May-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The text in bold has been added

Section 4.8
Cardiac Disorders

Common:
AV 1st degree block (ECG prolonged PQ interval)
Updated on 28/08/2007 and displayed until 06/08/2009
Reasons for adding or updating:
  • 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 4.8 - Undesirable effects
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to Sections 2, 3, 4.2 and 4.8.
Updated on 25/01/2006 and displayed until 28/08/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Ivabradine hydrochloride