Coverdine

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 14 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 13 March 2019 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Updated on 20 November 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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
  • Discontinuation of one or more strengths

Updated on 29 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 August 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 18 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 18 April 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 4.6 - 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

4.4          Special warnings and precautions for use

4.5          Interaction with other medicinal products and other forms of interaction

4.6          Fertility, pregnancy and lactation

4.8          Undesirable effects

Updated on 31 May 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 25 January 2016 SmPC

Reasons for updating

  • 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

$0$0In section 4.5 “Interaction with other medicinal products and other forms of interaction”: addition of interaction with allopurinol (combination requiring precaution for use).$0$0In section 4.6 “Fertility, Pregnancy and Lactation”: compliance with the latest version of the CMDh QRD template (revised April 2013). $0$0In section 4.8 “Undesirable effects”: addition of myopia, blurred vision and visual impairment (SOC eyes disorders).$0$0

Updated on 3 December 2015 SmPC

Reasons for updating

  • 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

Section 4.5 “Interaction with other medicinal products and other forms of interaction”: addition of interaction with allopurinol (combination requiring precaution for use).

-  Section 4.6 “Fertility, Pregnancy and Lactation”: compliance with the latest version of the CMDh QRD template (revised April 2013).

- Section 4.8 “Undesirable effects”: addition of myopia, blurred vision and visual impairment (SOC eyes disorders).

 

Updated on 2 October 2015 SmPC

Reasons for updating

  • 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

In section 4.8 (undesirable effects) - addition of extrapyramidal syndrome with a frequency 'unknown'

Updated on 5 May 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 1 May 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

$0In section4.3 (Contraindications), the following text (bold font) has been inserted:$0$0Concomitant use ofCoverdine with aliskiren-containing products inpatients with diabetes mellitus or renal impairment (GFR < 60mL/min/1.73 m2)(See section 4.5 and 5.1)”.$0$0In section4.4 (Special warnings and precautions for use), additional information on ‘Dualblockade of the renin-angiotensin-aldosterone system (RAAS) has been included’.$0$0In section4.5 (Interaction with other medicinal products and other forms of interaction),additional information on dual blockade of the renin-angiotensin-aldosteronesystem (RAAS) has been included.$0$0In section5.1 (Pharmacodynamic properties), clinical trial data has been included.$0

Updated on 9 October 2014 SmPC

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 3 October 2014 PIL

Reasons for updating

  • New PIL for new product