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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: 08/12/2011
SPC Exforge 5mg/160mg 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 08/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   22-Nov-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
All revised sections have just had the language clarified / simplified and some already approved paragraphs have been moved to more relevant parts of SmPC.
The only real new change occurs in section 4.8 where the following paragraph has been added:

"The following adverse reactions were found to be the most frequently occurring or the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush."
Updated on 08/08/2011 and displayed until 08/12/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   27-Jul-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 5.1 - inclusion of data from 5 Phase IV trials.  Updated BMI wording re: consistent efficacy in obese patients.  Original MA approved wording on less oedema with 5/80mg dose was take out at CHMP request.
Updated on 01/07/2010 and displayed until 08/08/2011
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   17-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Additional pack size
Updated on 04/06/2010 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   24-Nov-2009
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 has been increased from 30 months to 36 months
Updated on 15/04/2009 and displayed until 04/06/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

update of the SPC section 4.6 to implement the CHMP recommendation on a harmonised labelling relating to the use of Angiotensin II Receptor Antagonists during pregnancy and lactation
Updated on 13/03/2009 and displayed until 15/04/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

1. Added myocardial infarction, increased angina and arrhythmia in the amlodipine paragraph of the undesirable effect section 4.8.

2. Complete dthe valsartan paragraph of the undesirable effect section with the information about the potential increased risk of neutropenia.
Updated on 16/07/2008 and displayed until 13/03/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.3: "Pregnancy" contraindication was revised to "Second and third trimesters of pregnancy (see section 4.4 and 4.6)"
Section 4.4: A new paragraph concerning the use of AIIRAs was added under the heading of "Pregnancy"
Section 4.6: New data was concerning the use of AIIRAs was added under the "Pregnancy and Lactation" heading
Section 6.5: A new pack size was added - 280 (4 x 70)
Updated on 25/06/2008 and displayed until 16/07/2008
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:   12/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.3:  Updated shelf life from 18 - 30 months
Section 10: Updated date of revision to December 2007
Updated on 02/04/2007 and displayed until 25/06/2008
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Valsartan
  Amlodipine besilate