Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets *

  • Company:

    Novartis Ireland Limited
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 07 September 2021

File name

Entresto_REG PIL_PF21-0230_September 2021_Clean_1631003430.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 31 May 2021

File name

Entresto_REG PIL_PF21-0077_Clean_1622453416.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 31 May 2021

File name

Entresto_REG SPC_PF21-0077_19.05.2021_IPHA_1622453250.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Addition to Section 4.2:

Splitting or crushing of the tablets is not recommended.

Addition to Section 4.4:

Psychiatric disorders

Psychiatric events such as hallucinations, paranoia and sleep disorders, in context of psychotic events, have been associated with sacubitril/valsartan use. If a patient experiences such events, discontinuation of sacubitril/valsartan treatment should be considered.

Change to Section 4.5 (underlined = added; red = removed):

Lithium

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors or angiotensin II receptor antagonists including sacubitril/valsartanInteractions between sacubitril/valsartan and lithium have not been investigated.

Addition to Section 4.8:

Psychiatric disorders

Hallucinations**

Rare

Sleep disorders

Rare

Paranoia

Very rare

 

Updated on 05 October 2020

File name

Entresto REG PIL_PF 20-0176_September 2020_Clean_1601912225.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 September 2020

File name

Entresto REG PIL_PF 20-0176_September 2020_Clean_1601378911.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 August 2020

File name

Entresto REG PIL PF 20-0124_Clean_IPHA_1597152922.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 08 July 2020

File name

Entresto REG PIL PF 20-0124_Clean_IPHA_1594223193.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Removal of Black Inverted Triangle

Updated on 08 July 2020

File name

Entresto REG SPC PF 20-0124 June 2020 IPHA_1594223000.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Removal of Black Inverted Triangle

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

Updated on 28 November 2019

File name

Entresto REG SPC PF 19-0261 November 2019 IPHA_1574952639.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 28 November 2019

File name

Entresto REG PIL PF 19-0261_Clean_IPHA_1574952089.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 26 November 2019

File name

Entresto REG_PIL_1230624_1230625_R91_TA_p2_LFT_X-4_PF 18-0144__IPHA_1574783964.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 08 April 2019

File name

EntrestoFCTab_REG_SmPC_PF18-0065_IPHA_1554714164.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 25 September 2018

File name

Entresto REG_PIL_1230624_1230625_R91_TA_p2_LFT_X-4_PF 18-0144_RA Approved 12.09.2018_IPHA_1537871306.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 21 August 2018

File name

Entresto REG_PIL_1229758_1229759_R91_TA_p1_LFT_X-4_IPHA_1534858460.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 14 May 2018

File name

EntrestoFCTab_REG_SmPC_PF18-0065_clean.docx

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)

Updated on 09 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 17 November 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 17 November 2017

File name

PIL_16526_703.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 11 October 2017

Reasons for updating

  • 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

Section 6.5 - addition of multipacks containing 196 (7x28) film‑coated tablets.

Updated on 28 March 2017

Reasons for updating

  • 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

Section 6.3 - Shelf life was increased from 30 months to 3 years

Updated on 27 July 2016

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

Section 4.5 - Added "No clinically relevant drug-drug interaction was observed when simvastatin and Entresto were co-administered." under the heading

Interactions requiring precautions; OATP1B1 and OATP1B3 substrates, e.g. statins

Updated on 14 March 2016

Reasons for updating

  • Introduction of new pack/pack size

Updated on 15 February 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Section 6.5: updated to include new pack sizes
Section 8: updated to include the new EU numbers corresponding to new pack sizes

Updated on 01 December 2015

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 November 2015

Reasons for updating

  • New PIL for new product