EZETROL 10 mg Tablets

Product Information *

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 28 August 2020

File name

QRD-EZETROL-DE-H-0396-0399-001-WS-687-PIL-IE-en-CRT (002).pdf_1598606243.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 28 August 2020

File name

QRD-EZETROL-DE-H-0396-0399-001-WS-687-PIL-IE-en-CRT (002).pdf_1598606242.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 28 August 2020

File name

EZETROL-DE-H-0396-0399-001-WS-687-SPC-IE-en-CRT (002).pdf_1598605504.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

EU excipient guideline update and AE Table updateEU excipient guideline update and AE Table update

 

Updated on 17 June 2019

File name

EZETROL-DE-H-0396-001-NAT-20180622-SPC-IE-en-CRT_1560763690.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format 

Updated on 16 July 2018

File name

EZETROL_DE_H_0396_001_NAT_20180622_SPC_IE_en_CRT (2).docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Update to section 7 (Marketing Authorisation Holder), 8 (Marketing Authorisation Number(s)) and 10 (Date of revision of the text) of the SPC, following approval of the Marketing Authorisation Transfer application

Updated on 16 July 2018

File name

EZETROL_DE_H_ 0396_001_NAT_20180622_PIL_IE_en_CRT (2).pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 04 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 04 April 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Updates to SPC in line with the QRD template and editorial changes


Updated on 29 March 2018

File name

PIL_9189_218.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 11 February 2016

Reasons for updating

  • New SPC for new product

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

Updated on 11 February 2016

Reasons for updating

  • Changes to therapeutic indications

Updated on 11 February 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

SPC Change Details 4.1, 4.2, 4.4, 4.8, 5.1 
In section 4.1, a new indication for “Prevention of Cardiovascular Events” has been added (with corresponding updates to other sections)

Updated on 01 April 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

  • SPC sections have changed: Change to Section 2 - Qualitative and quantitative composition, Change to Section 4.1 - Therapeutic indications, Change to Section 4.2 - Posology and method of administration, Change to Section 4.3 – Contraindications, Change to Section 4.4 - Special warnings and precautions for use,  Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction, Change to Section 4.6 - Pregnancy and lactation, Change to Section 4.8 - Undesirable effects, Change to Section 5.1 - Pharmacodynamic properties, Change to Section 5.2 - Pharmacokinetic properties, Change to Section 9 - Date of renewal of authorisation and Change to Section 10 - Date of revision of the text

Updated on 31 March 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to dosage and administration

Updated on 04 November 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration

Updated on 05 September 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.4, 4.8, 5.1, 5.2 and 10 updated in line with Paediatric Study P05522.

Updated on 18 July 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

  • Change to Section 4.4 - Special warnings and precautions for use, Change to Section 4.8 - Undesirable effects, Change to Section 5.1 - Pharmacodynamic properties, Change to Section 10 - Date of revision of the text
    All sections are updated in line with  with new information based on the results of the SHARP (Study of Heart and Renal Protection) study

Updated on 19 June 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

  • MAH transfer from MSD-SP to MSD - Change to Section 7 - Marketing authorisation holder, Change to Section 8 - MA Number, Change to Section 10 - Date of revision of the text

Updated on 18 June 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 June 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Change to Section 3 - Pharmaceutical form – addition of tablet dimension

Change to Section 4.6 - Pregnancy and lactation – addition of statement on fertility

Change to Section 4.8 - Undesirable effects – editorial changes, postmarketing AEs added to table

Updated on 13 July 2011

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section

10: - Correction to revision date

Updated on 25 August 2010

Reasons for updating

  • 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

Section 5.1: Update for SEAS and ENHANCE studies

Updated on 25 May 2010

Reasons for updating

  • Change to side-effects

Updated on 15 March 2010

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

 

Inclusion of erythema multiforme in side effects
4.8 Undesirable effects
Ezetrol co-administered with fenofibrate:
Gastrointestinal disorders: abdominal pain
(common)
Post-marketing Experience
The following additional adverse reactions have been reported in post-marketing experience. Because these adverse experiences have been identified from spontaneous reports, their true frequencies are not known and cannot be estimated.

 

Blood and lymphatic system disorders: thrombocytopaenia
Nervous system disorders: dizziness; paraesthesia
Respiratory, thoracic and mediastinal disorders: dyspnoea
Gastrointestinal disorders: pancreatitis; constipation

Skin and subcutaneous tissue disorders: erythema multiforme
Musculoskeletal and connective tissue disorders: myalgia; myopathy/rhabdomyolysis (see section 4.4)
General disorders and administration site conditions: asthenia
Immune system disorders: hypersensitivity, including rash, urticaria, anaphylaxis and angio-oedema
Hepatobiliary disorders: hepatitis; cholelithiasis; cholecystitis
Psychiatric disorders: depression

 

Updated on 02 March 2010

Reasons for updating

  • Change to dosage and administration

Updated on 09 October 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.2, 4.4, 4.8 & 5.1: Paediatric details

Updated on 05 October 2009

Reasons for updating

  • Change to side-effects

Updated on 30 September 2009

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

SPC updated as result of renewal. No changes except to renewal date.

Updated on 21 January 2009

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

Section 6.3: shelf increase from 2 to 3 years.

Updated on 09 January 2009

Reasons for updating

  • Improved electronic presentation

Updated on 15 October 2008

Reasons for updating

  • Change to side-effects

Updated on 13 October 2008

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

Section 4.8: inclusion of depression and paraesthesia

Updated on 24 July 2008

Reasons for updating

  • Change to side-effects

Updated on 19 May 2008

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

The inclusion of dizziness in section 4.7 and 4.8

Updated on 10 March 2008

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 06 November 2007

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 4.5 - Fibrates section has been updated.

Section 5.1 - The Pharmacotherapeutic group has been updated.

Section 6.4 - The storage conditions have been updated to include 'in order to protect from moisture.

Updated on 09 March 2007

Reasons for updating

  • Change to side-effects
  • Change to warnings or special precautions for use

Updated on 04 January 2007

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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

Section 4.2 - Update to paediatric statement
Sections 4.4 & 4.5 - Update to Fibrates and Anticoagulants sections
Section 4.8 - Update to Clinical studies and co-administration with fenofibrate
section 5.1 - Inclusion of information regarding molecular target of ezetimibe

Updated on 02 December 2005

Reasons for updating

  • 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 02 December 2005

Reasons for updating

  • Change to drug interactions
  • Change to side-effects

Updated on 15 July 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 05 July 2005

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)

Updated on 28 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 October 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 17 May 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 09 January 2004

Reasons for updating

  • New SPC for new product

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