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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Indapamide, Perindopril arginine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/10/19

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Summary of Product Characteristics last updated on medicines.ie: 10/10/2019

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Servier Laboratories Ireland Ltd

Servier Laboratories Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACERYCAL Active Ingredients Amlodipine besilate, Perindopril arginine
Medicine Name Cosimprel 10mg/10mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Cosimprel 10mg/5mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Cosimprel 5mg/10mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Cosimprel 5mg/5mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Coverdine Active Ingredients Amlodipine, Indapamide, Perindopril
Medicine Name Coversyl Arginine 10mg Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 10mg orodispersible tablets Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 5mg Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 5mg orodispersible tablets Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine Plus 10mg/2.5mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Coversyl Arginine Plus 5 mg/1.25 mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Diamicron MR 30 mg Active Ingredients Gliclazide
Medicine Name Diamicron MR 60mg Active Ingredients Gliclazide
Medicine Name LIPERCOSYL Active Ingredients Atorvastatin calcium trihydrate, Perindopril arginine
Medicine Name LIPOCOMB Active Ingredients ezetimibe, Rosuvastatin Calcium
Medicine Name LONSURF Active Ingredients Tipiracil hydrochloride, Trifluridine
Medicine Name Natrilix SR Active Ingredients Indapamide
Medicine Name Oncaspar 750 U/ml powder for solution for injection/infusion Active Ingredients pegaspargase
Medicine Name Pixuvri 29 mg Active Ingredients Pixantrone dimaleate
Medicine Name Procoralan film-coated tablets Active Ingredients Ivabradine hydrochloride
Medicine Name Valdoxan 25mg Film-coated Tablets Active Ingredients Agomelatine
Medicine Name Vastarel 20mg Active Ingredients Trimetazidine dihydrochloride
1 - 0 of 24 items.Total: Infinity pages

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 10 October 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 18 June 2019 SmPC

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 SmPC

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 PIL

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 July 2017 PIL

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 9 May 2017 SmPC

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 9 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 January 2017 PIL

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 8 November 2016 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 22 April 2015 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to further information section

Updated on 31 July 2009 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product