Edarbi Tablets
- Name:
Edarbi Tablets
- Company:
Takeda Products Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/02/21

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Takeda Products Ireland Ltd

Company Products
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 3 February 2021 SPC
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 3 February 2021 PIL
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 22 March 2019 SPC
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 PIL
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 SPC
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 SPC
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:
|
10. Date of revision of the text |
14 November 2016 |
Updated on 28 November 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 28 November 2016 PIL
Reasons for updating
- Removal of black triangle
Updated on 20 November 2014 PIL
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 2 October 2014 SPC
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
Updated on 26 September 2014 PIL
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 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 10 March 2014 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 6 January 2014 PIL
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 3 July 2012 PIL
Reasons for updating
- New PIL for new product