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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: 31/03/2011
SPC Nebilet

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 31/03/2011 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   11-Mar-2011
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 01/11/2007 and displayed until 31/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable effects - update information on immune system disorders
Updated on 13/06/2006 and displayed until 01/11/2007
Reasons for adding or 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
Date of revision of text on the SPC:   05/2006
Legal Category:   POM

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 13/06/2006 and displayed until 13/06/2006
Reasons for adding or 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
Date of revision of text on the SPC:   05/2006
Legal Category:   POM

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 07/02/2006 and displayed until 13/06/2006
Reasons for adding or 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
Updated on 10/08/2004 and displayed until 07/02/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Nebivolol hydrochloride