Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal 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 08 May 2025
File name
Entresto tablets_REG PIL_PF25-0064_02.05.2025_clean_IPHA.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 08 May 2025
File name
Entresto Tablets_REG SPC_PF25-0064_02.05.2025_clean_IPHA.pdf
Reasons for updating
- 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)
Updated on 04 March 2025
File name
Entresto Tablets_REG SPC_PF25-0024_21.02.2025_clean_IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 March 2025
File name
Entresto tablets_REG PIL_PF25-0024_21.02.2025_clean_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 21 January 2025
File name
Entresto Tablets_REG SPC_PF25-0020_28.11.2024_clean_IPHA.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 August 2024
File name
Entresto tablets_REG PIL_Removal of UK(NI)_August 2024.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Updated to remove details for United Kingdom (Northern Ireland)
Updated on 08 June 2023
File name
Entresto tablets_REG PIL_PF22-0118 and PF23-0063_26.05.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 08 June 2023
File name
Entresto Tablets_REG SPC_PF22-0118 and PF23-0063_26.05.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 April 2023
File name
Entresto_REG PIL_PF23-0004_09.2021_clean_IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 September 2021
File name
Entresto_REG PIL_PF21-0230_September 2021_Clean.pdf
Reasons for updating
- Change to other sources of information section
Updated on 31 May 2021
File name
Entresto_REG PIL_PF21-0077_Clean.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.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/valsartan. Interactions 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.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.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.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.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.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.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.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.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 08 April 2019
File name
EntrestoFCTab_REG_SmPC_PF18-0065_IPHA.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.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.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
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
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
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 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
Updated on 27 November 2015
Reasons for updating
- New PIL for new product
Novartis Ireland Limited
Address:
Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, IrelandMedical Information E-mail:
medinfo.dublin@novartis.comTelephone:
+353 1 2601255Fax:
+353 1 2601263