Cibacen 5mg Film Coated Tablets

Product Information *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 14 May 2021

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 30 July 2018

Reasons for updating

  • New PIL for new product

Updated on 30 July 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 03 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 03 January 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

In section 4.5: Information regarding interaction has been added
In section 10: date of revision has changed

Updated on 03 January 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.5: Information regarding interaction has been added
In section 10: date of revision has changed

Updated on 14 October 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • 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

In section 4.4: Information regarding ciclosporin and heparin has been added. Information regarding mTOR inhibitors and NSAIDs has been added.

In section 4.9: Information to overdose has been added.

In section 10: Date of revision changed.

Updated on 14 October 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.4: Information regarding ciclosporin and heparin has been added. Information regarding mTOR inhibitors and NSAIDs has been added.

In section 4.9: Information to overdose has been added.

In section 10: Date of revision changed.

Updated on 05 January 2015

Reasons for updating

  • 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 - how to report a side effect
  • 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

In section 4.1: Text is added to refer to other sections

In section 4.2: Text is added to refer to other sections. Reference has changed to elderly patients

In section 4.3: Concomitant use with aliskiren-containing products has been added as a contraindication

In section 4.4: Information regarding dual blockade of the renin-angiotensin-aldosterone system has been added

In section 4.5: Information regarding clinical trial data and dual blockade of the renin-angiotensin-aldosterone system has been added

In section 4.8: Statement regarding adverse reporting has been added

In section 5.1: Text regarding particular clinical trials ONTARGET and  VA NEPHRON-D has been added. Information regarding ALTITUDE study has been added.

In section 10: date of revision has changed

Updated on 05 January 2015

Reasons for updating

  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1: Text is added to refer to other sections

In section 4.2: Text is added to refer to other sections. Reference has changed to elderly patients

In section 4.3: Concomitant use with aliskiren-containing products has been added as a contraindication

In section 4.4: Information regarding dual blockade of the renin-angiotensin-aldosterone system has been added

In section 4.5: Information regarding clinical trial data and dual blockade of the renin-angiotensin-aldosterone system has been added

In section 4.8: Statement regarding adverse reporting has been added

In section 5.1: Text regarding particular clinical trials ONTARGET and  VA NEPHRON-D has been added. Information regarding ALTITUDE study has been added.

In section 10: date of revision has changed

Updated on 30 January 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.3: the shelf-life has been reduced from 3 years to 2 years
In section 10: the date of revision has changed to January 2013

Updated on 30 January 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

In section 6.3: the shelf-life has been reduced from 3 years to 2 years
In section 10: the date of revision has changed to January 2013

Updated on 04 December 2012

Reasons for updating

  • 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
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

·         In section 4.4: a short warning regarding angioedema has been added

·         In section 4.5: an additional warning regarding the interaction of gold has been added

·         In section 4.8: there has been several changes made to the undesirable effects

·         In section 5.1: an additional statement has been added relating to the use of Cibacen in CHF patients

·         In section 10: the date of revision has been changed to November 2012

Updated on 04 December 2012

Reasons for updating

  • 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
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

·         In section 4.4: a short warning regarding angioedema has been added

·         In section 4.5: an additional warning regarding the interaction of gold has been added

·         In section 4.8: there has been several changes made to the undesirable effects

·         In section 5.1: an additional statement has been added relating to the use of Cibacen in CHF patients

·         In section 10: the date of revision has been changed to November 2012

Updated on 02 November 2011

Reasons for 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.3; Additional information regarding contradindications have been added
In section 4.4; warnings against the use of ACE inhibitors in pregnancy have been added
In section 4.6; the section has been restructed to include ACE inhibitor warnings in pregnancy and lactation
In section 5.2; additional information regarding lactation has been added
In section 10; the date of revision has changed

Updated on 02 November 2011

Reasons for 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 5.2 - Pharmacokinetic 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

In section 4.3; Additional information regarding contradindications have been added
In section 4.4; warnings against the use of ACE inhibitors in pregnancy have been added
In section 4.6; the section has been restructed to include ACE inhibitor warnings in pregnancy and lactation
In section 5.2; additional information regarding lactation has been added
In section 10; the date of revision has changed

Updated on 18 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to March 2011

Updated on 18 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to March 2011

Updated on 20 April 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 2: Small text change
Section 3: Change in description of tablet
Section 4.2: Paediatric information added
Section 4.5: Minor text correction
Section 4.8: additional Information
Section 4.9: Correction of text
Section 5.1: Additional information
Section 5.2:  Additiona paediatric information
Section 5.3:  Additional information
Section 9: Change of format
Section 10: Change of date of revision
 

Updated on 20 April 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 2: Small text change
Section 3: Change in description of tablet
Section 4.2: Paediatric information added
Section 4.5: Minor text correction
Section 4.8: additional Information
Section 4.9: Correction of text
Section 5.1: Additional information
Section 5.2:  Additiona paediatric information
Section 5.3:  Additional information
Section 9: Change of format
Section 10: Change of date of revision
 

Updated on 04 October 2007

Reasons for updating

  • Change to marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

MAH change from

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UK
 
to
 

Meda Health Sales Ireland Ltd

Office 10, Dunboyne Business Park

Dunboyne

Co. Meath
 
PA number changed from
PA 13/78/1
to
PA 1332/1/1
 
 
 
 

Updated on 04 October 2007

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

MAH change from

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

UK
 
to
 

Meda Health Sales Ireland Ltd

Office 10, Dunboyne Business Park

Dunboyne

Co. Meath
 
PA number changed from
PA 13/78/1
to
PA 1332/1/1
 
 
 
 

Updated on 05 August 2005

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Updated on 05 August 2005

Reasons for updating

  • Change to section 6.1 - List of excipients

Updated on 04 February 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 04 February 2005

Reasons for updating

  • New SPC for medicines.ie