Coverdine *

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

Coverdine PIL_1632923384.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 26 July 2021

File name

Coverdine common PIL_1627311727.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

Coverdine SmPC 072021 medicines.ie_1627309399.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 - how to report a side effect
  • 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

Coverdine PIL_1607516942.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 10 October 2019

File name

Coverdine SmPC_1570707123.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

Coverdine PIL_1570707097.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 March 2019

File name

Coverdine PIL_1552495247.pdf

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

File name

Coverdine SmPC_1552495323.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 4.6 - 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

File name

Coverdine SmPC_1542724289.pdf

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

File name

COVERDINE.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

COVERDINE.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
  • Discontinuation of one or more strengths

Updated on 29 August 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 29 August 2017

File name

PIL_16125_315.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 April 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 4.6 - 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 18 April 2017

Reasons for updating

  • New SPC for new product

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

Updated on 31 May 2016

Reasons for updating

  • Change to side-effects

Updated on 25 January 2016

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 03 December 2015

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 02 October 2015

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 05 May 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 01 May 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

$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 09 October 2014

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 03 October 2014

Reasons for updating

  • New PIL for new product