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A.Menarini Pharmaceuticals Ltd
2nd Floor, Castlecourt, Monkstown, Monkstown, Co. Dublin, Ireland
Telephone: +353 1 284 6744
Fax: +353 1 284 6769
E-mail: ireland@menarini.ie
Medical Information Direct Line: 1800 283 045
Summary of Product Characteristics last updated on medicines.ie: 14/06/2011
SPC Nebilet Plus 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 14/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • 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
Date of revision of text on the SPC:   25-May-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


The main changes are as follows:

 

Section 4.3 Contra-indications:

  • replace the word 'heart' with 'atrioventricular’ in the wording - Second and third degree atrioventricular block (without a pacemaker).
  • remove wording relating to during the second and third trimester of pregnancy or lactation. 

Section 4.4 Special warnings and precautions for use:

  • replace the word 'heart' with 'atrioventricular’ in the wording - in patients with first degree atrioventricular block, because of the negative effect of beta-blockers on conduction time;

Section 4.5 and section 5.1:

  • Correct the spelling of the word "sympathomimetic"

Section 4.6 Pregnancy and lactation:

  • Amend the wording to align with that agreed by the CMD/PhvWP regarding the use of hydrochlorothiazide during pregnancy and lactation. 
Updated on 30/03/2010 and displayed until 14/06/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   09-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 extended from 2 to 3 years.
Updated on 01/10/2009 and displayed until 30/03/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Hydrochlorothiazide
  Nebivolol hydrochloride