EZETROL 10 mg Tablets
- Name:
EZETROL 10 mg Tablets
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/08/20
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MSD Ireland (Human Health) Limited
Company Products
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 PIL
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 PIL
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 SPC
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 SPC
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 SPC
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 PIL
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 4 April 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 April 2018 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 29 March 2018 PIL
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 SPC
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 PIL
Reasons for updating
- Changes to therapeutic indications
Updated on 11 February 2016 SPC
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
In section 4.1, a new indication for “Prevention of Cardiovascular Events” has been added (with corresponding updates to other sections)
Updated on 1 April 2015 SPC
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 PIL
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 4 November 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 5 September 2013 SPC
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
Updated on 18 July 2013 SPC
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 SPC
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 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 10 June 2013 SPC
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 SPC
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 SPC
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
Updated on 25 May 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 15 March 2010 SPC
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 2 March 2010 PIL
Reasons for updating
- Change to dosage and administration
Updated on 9 October 2009 SPC
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
Updated on 5 October 2009 PIL
Reasons for updating
- Change to side-effects
Updated on 30 September 2009 SPC
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
Updated on 21 January 2009 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
Section 6.3: shelf increase from 2 to 3 years.
Updated on 9 January 2009 PIL
Reasons for updating
- Improved electronic presentation
Updated on 15 October 2008 PIL
Reasons for updating
- Change to side-effects
Updated on 13 October 2008 SPC
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 PIL
Reasons for updating
- Change to side-effects
Updated on 19 May 2008 SPC
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 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 6 November 2007 SPC
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 9 March 2007 PIL
Reasons for updating
- Change to side-effects
- Change to warnings or special precautions for use
Updated on 4 January 2007 SPC
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
Updated on 2 December 2005 SPC
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 2 December 2005 PIL
Reasons for updating
- Change to drug interactions
- Change to side-effects
Updated on 15 July 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 5 July 2005 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)
Updated on 28 October 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 28 October 2004 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 17 May 2004 SPC
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 9 January 2004 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)