Nebilet *

When a pharmaceutical company changes any document, 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 29 January 2019

File name

ie-pl Nebilet 103 approved clean 23-1-19_1548768999.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 29 January 2019

File name

ie-spc Nebilet approved clean 23-1-19_1548768930.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.1 List of excipients - E numbers added.

Updated on 17 May 2018

File name

ie_spc_Nebilet_clean_10_4_18_ipha.docx

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 5.1 Pharmacodynamic properties

The following sentence has been added:

Available preclinical and clinical evidence in hypertensive patients has not shown that nebivolol has a detrimental effect on erectile function. 

Section 10 Date of revision of the text

Updated to April 2018

 

Updated on 17 February 2015

File name

PIL_7903_960.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 February 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects

Add urticaria as a side-effect (frequency - not known)

Add HPRA details for the reporting of side-effects

 

Administrative amendments to align to the EU QRD template

Sections 2, 4.2, 4.3, 4.4, 9.

 

Section 10 Date of revision of the text

Updated to January 2015

Updated on 17 February 2015

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 24 January 2012

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 24 June 2011

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 31 March 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Addition of baclofen in section 4.5 Interactions (under combinations to be used with caution), together with minor changes to the wording of sections 2, 3 and 6.1. Date of renewal and revision of the text updated in section 9 and 10.

Updated on 30 March 2011

Reasons for updating

  • Change to storage instructions
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 24 July 2008

Reasons for updating

  • Change to further information section

Updated on 05 June 2008

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 12 February 2008

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 01 November 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Undesirable effects - update information on immune system disorders

Updated on 23 November 2006

Reasons for updating

  • Change to packaging

Updated on 13 June 2006

Reasons for updating

  • Change to storage instructions

Updated on 13 June 2006

Reasons for 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 4.4 - Special warnings and precautions for use
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to the SMPC following Marketing Authorisation renewal.
Main changes are:
Section 4.3 Contraindations for pregnancy and lactation removed.
Section 4.4 Lactose warning added.
Section 4.6 Updated pregnancy and lactation information.
Section 4.8 Updated Adverse event table for hypertension.
 

Updated on 13 June 2006

Reasons for 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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to the SMPC following Marketing Authorisation renewal.
Main changes are:
Section 4.3 Pregnancy and lactation removed as a Contraindication
Section 4.4 Lactose warning added.
Section 4.6 Pregancy and lactation information updated.
Section 4.8 Adverse event  table for hypertension updated.
 

Updated on 03 April 2006

Reasons for updating

  • Change to dosage and administration

Updated on 07 February 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 February 2006

Reasons for updating

  • Change to appearance of the medicine
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 September 2005

Reasons for updating

  • Improved electronic presentation

Updated on 10 August 2004

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 August 2004

Reasons for updating

  • New PIL for new product