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

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • 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

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

File name

PIL_16526_703.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 November 2017

Reasons for updating

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

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