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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: 30/03/2012
SPC Co-Diovan 160 mg/12.5 mg film-coated 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 30/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   21-Mar-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.6 - added text re lactation:

Thiazides in high doses causing intense dieresis can inhibit the milk production.

 

If Co-Diovan is used during breast feeding, doses should be kept as low as possible.

 
Updated on 05/05/2011 and displayed until 30/03/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   25-Mar-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 4.8 Hyponatraemia was added as a side effect with not known frequency, as a result of RMS comments from the PRAR.
Updated on 05/11/2009 and displayed until 05/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   16-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
The SPC was harmonised under an Artilcle 30 referral procedure in order to standardise the SPC's of all MRP Member States.

The changes in most of the outlined sections were minor re-formatting and re-wording for clarity and harmonisation purposes.  The main change of signficance was in section 4.6 Pregnancy and Lactation, where Co-Diovan has gone from being totally contraindicated in pregnancy to now being not recommended in the first trimester of pregnancy and contraindicated in the second and third trimesters of pregnancy.
Updated on 12/06/2008 and displayed until 05/11/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to SPC Sections 4.2, 4.4, 4.5, 4.6 & 4.8 due to renewal
Updated on 04/05/2006 and displayed until 12/06/2008
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Updated on 01/02/2005 and displayed until 04/05/2006
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 27/07/2004 and displayed until 01/02/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Hydrochlorothiazide
  Valsartan