Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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 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