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Novartis Ireland Limited
Beech House, Beech Hill Office Campus, Clonskeagh, Dublin 4,
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 14/03/2012
SPC Diovan 160 mg Film-coated Tablet

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 14/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   06-Mar-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.4 Added in text:
"

History of angioedema

Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should be immediately discontinued in patients who develop angioedema, and Diovan should not be re-administered."
Updated on 12/04/2011 and displayed until 14/03/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   03-Nov-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 Added "Hyponatraemia" with frequency unknown.
Section 6.1 Updated excipient name of crospovidone to crospovidone Type A
Updated on 09/06/2010 and displayed until 12/04/2011
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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   25-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Sections 3, 6.4 and 6.5 were updated as a result of the Quality CMC harmonsiation procedure.
Section 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 were all updated as a result of the new paediatric indication, taking into account the new Diovan 3mg/ml oral solution which has been introduced.
Updated on 30/06/2009 and displayed until 09/06/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   28-Apr-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
All of the changes made to this SPC were as a result of the MRP Harmonisation procedure, i.e. bringing the SPC of countries who previously only had Diovan approved nationally inline with the SPC of all the current MRP countries, of which Ireland is one.  Therefore most of the changes were formatting and tidying up sections - the only main change for Ireland occured in section 4.3 and 4.6 relating to pregnancy which was previously contraindicated altogether, but now is only contraindicated for second and third trimesters.
Updated on 01/05/2007 and displayed until 30/06/2009
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Date of last revision corrected
Updated on 17/04/2007 and displayed until 01/05/2007
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes following completion of renewal
Updated on 23/01/2007 and displayed until 17/04/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Correction of revision date
Updated on 24/10/2006 and displayed until 23/01/2007
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.6: The phrase "There have been reports of spontaneous abortion, oligohydramnios and newborn renal dysfunction, when pregnant women have inadvertently taken valsartan." has been added.
 
 
Section 4.9: The phrase "Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock." has been added.
 
 
In addition to the changes listed above, various sentences have been reworded throughout the SPC.
Updated on 24/02/2006 and displayed until 24/10/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.5 - Nature and contents of container
Updated on 15/08/2005 and displayed until 24/02/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Updated on 29/03/2005 and displayed until 15/08/2005
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 04/02/2005 and displayed until 29/03/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Valsartan