Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets

Product Information *

  • Company:

    Servier Laboratories Ireland Ltd
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 26 July 2021

File name

Coversyl Arginine Plus 2.5 0.625mg PIL_1627310293.pdf

Reasons for updating

  • 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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 July 2021

File name

Cov Arg Plus 2.5 0.625mg SmPC 072021_1627310259.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 December 2020

File name

Coversyl Arginine Plus 2.5mg.0.625mg PIL_1607518315.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 10 October 2019

File name

Coversyl Arginine Plus 2.5mg-0.625mg_1570707340.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 10 October 2019

File name

Coversyl Arginine Plus PIL 2.5mg-0.625mg_1570707311.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 18 June 2019

File name

Coversyl Arginine PLUS 2.5mg.0.625mg film coated tablets_1560868409.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 29 May 2018

File name

Coversly Arginine Plus 2.5mg.0.625mg film-coated tablets.docx

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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)

Updated on 29 May 2018

File name

Coversly Arginine Plus 2.5mg.0.625mg film-coated tablets.pdf

Reasons for updating

  • 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 4 - possible side effects

Updated on 19 July 2017

File name

PIL_14815_732.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 08 May 2017

Reasons for updating

  • 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

- 4.4    Special warnings and precautions for use

- 4.5    Interaction with other medicinal products and other forms of interaction

- 4.8    Undesirable effects

 

Updated on 08 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 09 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 5 - how to store or dispose

Updated on 08 November 2016

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • 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

1) In sections 4.5 Type II C.I.4: to implement the changes submitted in February 2014 for indapamide. (Interaction with allopurinol and updating potassium-sparing diuretics [section 4.5],

2) In section 4.6 April 2013 CMDh QRD template implemented

3) In section 4.8 Addition of SOC eye disorders  

4) In sections 4.3, 4.4, 4.5, 4.6, 4.8 Type II C.I.4: to implement changes approved last August 2013 for perindopril (Coversyl*).

 

Updated on 23 April 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 22 April 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

In section 4.3 (Contraindications), the following text has been added: "Concomitant use of  COVERSYLARGININE PLUS 2.5mg/0.625mg with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR< 60 ml/min/1.73m²) (see sections 4.5 and 5.1)."$0$0$0$0In section 4.4 (Special warnings and precautions for use), additional information in relation to "Dual blockade of the renin-angiotensin-aldosterone system" has been added.$0$0$0$0$0In section 4.5 (Interaction with other medicinal products and other forms of interaction), the following text has been inserted:$0$0$0$0$0“Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).”$0$0$0$0$0In section 5.1 (Pharmacodynamic properties), clinical trial data has been inserted.$0

Updated on 18 February 2014

Reasons for updating

  • Change to product name

Updated on 10 January 2014

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 20 September 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Change to MA holder address$0$0$0$0In section 7 (Marketing Authorisation Holder) The following has been removed:$0Les Laboratoires Servier,$022, rue Garnier$092200 Neuilly-sur-Seine $0France$0$0and replaced with$0Les Laboratoires Servier$050, rue Carnot$092284 Suresnes cedex – France $0

Updated on 08 October 2010

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 07 October 2010

Reasons for updating

  • New PIL for new product