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Coversyl Arginine Plus 10mg/2.5mg film-coated tablets

  • Name:

    Coversyl Arginine Plus 10mg/2.5mg 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: 09/12/20

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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 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 ONIVYDE Active Ingredients Irinotecan hydrochloride trihydrate
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
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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 9 December 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 10 October 2019 SPC

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 7 May 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains

Updated on 7 May 2019 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

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

Updated on 29 May 2018 SPC

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 8 May 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 8 May 2017 SPC

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 2 March 2017 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

6.3     Shelf life

Change from 2 years to 3 years.

Updated on 9 January 2017 PIL

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 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 8 November 2016 SPC

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 SPC

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 10mg/2.5mg  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 theuse 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$0$0$0$0

Updated on 3 October 2012 SPC

Reasons for updating

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

$0Information on breastfeeding has been removed from section 4.4 and is now covered in $0$0more detail in section 4.6.$0$0$0$0$0In section 4.8 ‘Undesirable effects’ two new effects have been added. Syncope has $0$0been added under the heading Nervous system disorders and torsade de pointes $0$0(potentially fatal) has been added under the heading Cardiac disorders. The frequency of $0$0both these effects is unknown. $0$0$0$0$0Also in section 4.8, under the heading Investigations, there have been a number of $0$0formatting changes and ‘Electrocardiogram QT prolonged’ has been added.$0

Updated on 27 February 2012 SPC

Reasons for updating

  • 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

In section 7, marketing authorisation holder change from "Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine France" to "Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex"

Updated on 15 February 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 18 February 2010 PIL

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie

Updated on 8 December 2009 SPC

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