Coversyl Arginine Plus 5 mg/1.25 mg film-coated tablets *

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 29 September 2021

File name

PIL Cov Arg Plus PIL 5 1.25mg_1632923512.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 26 July 2021

File name

Coversyl Arginine Plus 5 1.25mg PIL_1627310114.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 5 1.25mg SmPC 072021_1627309929.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 4.8 - Undesirable effects
  • 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 5mg.1.25mg PIL_1607518383.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 10 October 2019

File name

Coversly Arginine Plus 5mg-1.25mg_1570707410.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 5mg.-1.25mg_1570707381.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 18 June 2019

File name

Coversyl Arginine PLUS 5mg.1.25mg film coated tablets_1560868604.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

Coversyl Arginine Plus 5mg.1.25mg 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

Coversyl Arginine Plus 5mg.1.25mg 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_12629_462.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 09 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 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 - warnings and precautions
  • 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 4 - possible side effects
  • 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 (bold font) has been added: "Concomitant use of  COVERSYLARGININE PLUS 5mg/1.25mg 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 ofinteraction), the following text has been inserted:$0$0$0$0$0"Clinical trial data has shown that dual blockade of therenin-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, hyperkalaemiaand 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 26 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$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$0

Updated on 25 August 2011

Reasons for updating

  • Change to further information section

Updated on 31 July 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

The following has been added to section 4.4:

Pregnancy and lactation:

ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

Use of perindopril is not recommended during breast feeding.

The following has been added to section 4.6:

Pregnancy :

Linked to perindopril :

The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contra-indicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive ; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.

Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).

Linked to indapamide:

 

Previous wording:
COVERSYL ARGININE PLUS 5mg/1.25mg should not be used during the first trimester of pregnancy. When a pregnancy is planned or confirmed the switch to an alternative treatment should be initiated as soon as possible. Controlled studies with ACE inhibitors have not been done in humans, but in a limited number of cases with first trimester exposure there do not appear to have been any malformations consistent with human fetotoxicity as described below.

COVERSYL ARGININE PLUS 5mg/1.25mg is contraindicated during the second and third trimesters of pregnancy (see section 4.3).

Prolonged ACE inhibitors exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, retardation of skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalemia) (see section 5.3).

Should exposure to COVERSYL ARGININE PLUS 5mg/1.25mg have occurred from the second trimester of pregnancy, an ultrasound check of renal function and the skull is recommended
 In section 4.6 regarding lactation

"Use of perindopril is not recommended during breast feeding"
 replaces the previous wording which was: The excretion of perindopril into breast milk is unknown
.

Updated on 15 July 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation

Updated on 15 November 2007

Reasons for updating

  • New PIL for new product

Updated on 15 November 2007

Reasons for updating

  • New SPC for new product

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