Cibacen 5mg Film Coated Tablets
- Name:
Cibacen 5mg Film Coated Tablets
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/07/18
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Mylan IRE Healthcare Limited
Company Products
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 30 July 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 30 July 2018 SmPC
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 3 January 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 3 January 2017 SmPC
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 10: date of revision has changed
Updated on 3 January 2017 PIL
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 10: date of revision has changed
Updated on 14 October 2016 SmPC
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 PIL
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 5 January 2015 PIL
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 changedUpdated on 5 January 2015 SmPC
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 changedUpdated on 30 January 2013 PIL
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 10: the date of revision has changed to January 2013
Updated on 30 January 2013 SmPC
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 10: the date of revision has changed to January 2013
Updated on 4 December 2012 PIL
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 4 December 2012 SmPC
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 2 November 2011 PIL
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 4.4; 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 2 November 2011 SmPC
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 4.4; 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 PIL
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 10: the date of revision has changed to March 2011
Updated on 18 March 2011 SmPC
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 10: the date of revision has changed to March 2011
Updated on 20 April 2009 SmPC
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
Updated on 20 April 2009 PIL
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
Updated on 4 October 2007 PIL
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Frimley
Camberley
GU16 7SR
Meda Health Sales Ireland Ltd
Office 10,
Dunboyne
Updated on 4 October 2007 SmPC
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
Frimley
Camberley
GU16 7SR
Meda Health Sales Ireland Ltd
Office 10,
Dunboyne
Updated on 5 August 2005 SmPC
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 5 August 2005 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
Updated on 4 February 2005 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 February 2005 PIL
Reasons for updating
- New SPC for medicines.ie