Coversyl Arginine Plus 5 mg/1.25 mg film-coated tablets
*Company:
Servier Laboratories Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 October 2022
File name
Coversyl Arginine Plus 5 1.25mg PIL.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 15 July 2022
File name
Coversyl Arginine Plus 5 1.25mg SmPC.pdf
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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 July 2022
File name
Coversyl Arginine Plus 5 1.25mg PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 September 2021
File name
PIL Cov Arg Plus PIL 5 1.25mg.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 26 July 2021
File name
Coversyl Arginine Plus 5 1.25mg PIL.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.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.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 10 October 2019
File name
Coversly Arginine Plus 5mg-1.25mg.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.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.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
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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 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
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
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 SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 November 2007
Reasons for updating
- New PIL for new product