INNOVACE TABLETS

Product Information *

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    Updated
  • 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 04 August 2021

File name

Innovace-SE-H-0404-WS-054-PIL-IE-en-CRT_1628086579.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 04 August 2021

File name

Innovace-SE-H-0404-001-004-WS-054-SPC-IE-en-CRT Jul 2021_1628086348.pdf

Reasons for updating

  • 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 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 PI regarding ACE inhibitors/Neprylisin inhibitors

Updated on 05 January 2021

File name

QRD-IE-INNOVACE-SE-H-0404-LFT-WS-422-Dec2020 (002)_1609846668.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update to section 2.0 to describe the sodium content in this medicine.

 

Updated on 05 January 2021

File name

INNOVACE-SE-H-0404-001-004-IB-WS422-SPC-IE-en-Dec2020 (002)_1609846078.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 section 4.4 to describe the sodium content in this medicine.

 

Updated on 04 December 2020

File name

QRD-IE-INNOVACE-2.5mg5mg10mg20mg-LFT-IA645G-Oct2020-CRT (002)_1607091474.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update to manufacturer details in section 6.0.

 

Updated on 27 November 2019

File name

INNOVACE-SE-H-0404-002-IA050-SPC-IE-en-CRT (002)_1574847317.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Deletion of the 60 tablet pack size for Innovace 5 mg Tablets

Updated on 27 November 2019

File name

QRD-INNOVACE-IA050-PIL-IE-en-CRT (002)_1574846956.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Deletion of a pack size

Updated on 20 June 2019

File name

QRD INNOVACE-WS-083+086-PIL-IE-en-CRT_1560932622.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 19 June 2019

File name

INNOVACE-SE-H-0404-001-004-WS-086-SPC-IE-en-CRT_1560933215.pdf

Reasons for updating

  • 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 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

New text regarding concomitant use of other drugs that may increase serum potassium levels (e.g. trimethoprim/sulfamethoxazole)

 

Updated on 28 March 2019

File name

QRD file - Innovace Leaflet -WS-083_CRT_1553763542.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions

Updated on 28 March 2019

File name

INNOVACE-SE-H-0404-001-004-II-WS-083-SPC-IE-en-CRT_1553763748.pdf

Reasons for updating

  • 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 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 regarding drug interaction between ACE-inhibitor and neprilysin (NEP) inhibitor resulting in an increased risk of angioedema

 

Updated on 29 August 2018

File name

INNOVACE-SE-H-0404-001-004-IAIN-046-SPC-IE-en-CRT Aug 2018 (2)_1535544752.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Change to section 6.5 Nature and contents of container e.g. Innovace 5 mg tablet has a new pack size of 56 tablets

 

Updated on 15 August 2018

File name

QRD file - Innovace Leaflet - Deletion of UK details + IA046-CRT (2)_1534337134.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 March 2018

File name

PIL_9237_75.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 March 2018

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 13 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

Updated on 10 May 2016

Reasons for updating

  • New SPC for new product

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

Updated on 10 May 2016

Reasons for updating

  • 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 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

Change to Section 4.4 - Special warnings and precautions for use

Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction

Change to Section 10 - Date of revision of the text
Reasons for submission: Type II036; Angiodema and ACE inhibitor and mTOR update

Updated on 10 February 2015

Reasons for updating

  • 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
  • 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

Reasons for submission: SE/H/404/001-004/IB/030-Article 31 Dual RAS Blockade

Change to Section 4.3 - Contraindications
Change to Section 4.4 - Special warnings and precautions for use

Change to Section 4.5 - Interactions 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

Updated on 09 February 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 26 June 2014

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Change to Section 9 - Date of renewal of authorisation

Updated on 21 May 2014

Reasons for updating

  • Change to MA holder contact details

Updated on 25 April 2014

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Which SPC sections have changed: Sections 7 & 8 Change information: Change to the MAH name and address and new PA numbers.

Updated on 13 March 2014

Reasons for updating

  • Change of contraindications
  • Change to information about pregnancy or lactation

Updated on 29 January 2014

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • 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 4.3, 4.4, 4.5, 4.6, 4.8
Detailed SPC change information: Added a warning that the combination of aliskiren-containing medicines and ACE inhibitors.

Updated on 24 September 2012

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 12 June 2012

Reasons for updating

  • 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 4.6 - 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

Section 4.4, 4.5, 4.6, 5.2, 10 - Added warnings on drug interactions; updated text on pregnancy and lactation

 

Updated on 11 February 2011

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 09 February 2011

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Update to section 4.5 - drug interactions (completion of II19) - Warnings on drug interactions

 

Updated on 08 June 2010

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 section 6.5 and 10 - Harmonised pack sizes

 

Updated on 07 June 2010

Reasons for updating

  • Change to further information section

Updated on 06 April 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • 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

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

Free text change information supplied by the pharmaceutical company

Renewal completion - Sections 2, 3, 4.8, 6.1, 6.4, 6.5
Detailed SPC change information: Composition, Storage conditions

 

Updated on 29 March 2010

Reasons for updating

  • Correction of spelling/typing errors

Updated on 17 November 2009

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Updated on completion of variation to reduce shelf-life II/16
Sections: 3, 6.1, 6.3:
Shelf-life reduced to 2 years.
Pharmaceutical form description - minor editorial changes.
Excipients names amended.

 

Updated on 03 September 2009

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

No change to any sections. (Section 4.6 duplicated and incorrectly placed before Sec. 4.5)
Deletion of Section 4.6 inserted incorrectly before Section 4.5

Deletion of Section 4.6 inserted incorrectly before Section 4.5

Updated on 10 March 2009

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

The changes are as a result of a variation to amend the following sections of the SmPC; 4.4 (Special warnings and special precautions for use), 4.6 (Pregnancy and lactation) and 5.2 (Pharmacokinetic properties) in response to the recommendation by the Pharmacovigilance Working Party regarding ACE inhibitors and lactation.

Updated on 06 February 2009

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

The variation to include the term "syndrome of inappropriate antidiuretic hormone secretion" (SIADH) has been added to section 4.8 of the SmPC.

Updated on 03 September 2008

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 27 August 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

changed due to a variation to update pregnancy warning, sections 4.4 and 4.6 updated

Updated on 07 February 2008

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to drug interactions
  • Change to side-effects

Updated on 23 August 2007

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

This update is due to changes in sections 4.4 and 4.5

Updated on 12 May 2006

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 March 2006

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 16 January 2006

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 16 November 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 16 November 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 21 February 2004

Reasons for updating

  • Change to joint SPC covering all presentations

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

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

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