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Edarbi Tablets

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Pharmacy Only: Prescription

Updated on 31 July 2024

File name

m1-3-1-Leaflet-Edarbi-IRE-clean July 2024doc.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 31 July 2024

File name

m1-3-1-SPC-Edarbi-IRE-clean July 2024.pdf

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container

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

Updated on 08 March 2022

File name

m1-3-1-Leaflet-Edarbi-IRE-clean Feb 2022.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

The following information has been updated: local representatives for Ireland, Slovenia and the United Kingdom in the Package Leaflet (PL)

Updated on 08 March 2022

File name

m1-3-1-SPC-Edarbi-IRE-clean Feb 2022.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

The SmPC has been updated in sections 4.2, 4.8, 5.1 and 5.2 with paediatric clinical data and in section 5.3 with data from juvenile animal toxicity studies which support the paediatric clinical studies and section 4.5 with data from clinical pharmacology studies. 

The product information has also been updated in line with the latest QRD template and to update the local representatives for Ireland, Slovenia and the United Kingdom in the Package Leaflet (PL).

Updated on 03 February 2021

File name

Edarbi SmPC IRE 19 Jan 2021.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update of section 4.4. with sodium content wording
Change in section 7 address of the marketing authorisation holder

Updated on 03 February 2021

File name

Edarbi PIL IRE 19 Jan 2021.pdf

Reasons for updating

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

Updated on 18 February 2020

File name

m1-3-1-Leaflet-Edarbi-IRE-06.01.2020.pdf

Reasons for updating

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

Updated on 22 March 2019

File name

m1-3-1-SPC-Edarbi-IRE-20.03.2018.pdf

Reasons for updating

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

A variation to introduce an alternative type of blister (non-desiccated) in addition to the currently approved blister (with desiccant) was approved for Edarbi on 20th March 2018. 

Updated on 22 February 2019

File name

m1-3-1-Leaflet-Edarbi-IRE-20.03.2018.pdf

Reasons for updating

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

Updated on 21 December 2016

Reasons for updating

  • New SPC for new product

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

Updated on 21 December 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

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

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

 

Removal of Black triangle.

4.2 Posology and method of administration

Removal of the following wording:

Heart failure

Caution should be exercised in hypertensive patients with congestive heart failure as there is no experience of use of Edarbi in these patients (see section 4.4

 

10. Date of revision of the text

9 September 2014

14 November 2016

Updated on 28 November 2016

File name

PIL_15407_479.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 November 2016

Reasons for updating

  • Removal of black triangle

Updated on 20 November 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 02 October 2014

Reasons for updating

  • Addition of joint SPC covering all presentations

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 26 September 2014

Reasons for updating

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

Updated on 13 June 2014

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 10 March 2014

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 06 January 2014

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 03 July 2012

Reasons for updating

  • New PIL for new product