Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets *
Pharmacy Only: Prescription

Updated on 29 September 2021

File name

PIL Cov Arg Plus 2.5 0.625mg_1632923475.pdf

Reasons for updating

  • Improved presentation of PIL

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

  • New SPC for new product

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

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 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