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Vastarel 20mg

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Pharmacy Only: Prescription
  • Vastarel packshot with blisters.jpeg

Updated on 19 December 2023

File name

Vastarel PIL.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 23 January 2023

File name

Vastarel 20 mg SmPC.pdf

Reasons for updating

  • Document format updated

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

Updated on 23 March 2021

File name

Vastarel 20 mg PIL.pdf

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 24 February 2021

File name

Vastarel 20 mg SmPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 24 February 2021

File name

Vastarel 20 mg PIL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 December 2020

File name

Vastarel 20mg PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 19 May 2020

File name

Vastarel 20mg SmPC.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 19 May 2020

File name

Vastarel 20mg PIL.pdf

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 20 November 2018

File name

Vastarel 20mg PIL.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 20 November 2018

File name

Vastarel 20mg.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 27 June 2018

File name

Vastarel PIL Jan 01.2018.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 26 June 2018

File name

VASTAREL 20mg.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 26 June 2018

File name

Vastarel 20mg.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 January 2018

File name

PIL_8835_646.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 15 January 2018

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 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

4.4. Special warnings and precautions for use

6.1. List of excipients

Updated on 15 January 2018

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - what the product looks like and pack contents

Updated on 03 August 2017

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. Undesirable effects

 

Updated on 01 August 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 17 August 2016

Reasons for updating

  • Removal of black triangle

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

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle

Updated on 28 June 2016

Reasons for updating

  • Removal of black triangle

Updated on 14 December 2015

Reasons for updating

  • Change to further information section

Updated on 18 November 2015

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company



In section 5.2  (Preclinical safety data)

Chronic toxicity studies conducted by the oral route in dogs (5 to 40 mg.kg-1.d-1) and rats (5 to 200 mg.kg-1.d-1), showed a good safety profile.

Neither embryo-foetotoxic effects nor teratogenicity were detected in mice and in rabbits. The general study on reproduction and embryogenesis in 3 generations of rats showed no anomalies. The genotoxic potential was thoroughly assessed with three in vitro studies including the evaluation of the mutagenic and clastogenic potential and one in vivo study. All tests were negative.

 

 

 

Updated on 03 October 2014

Reasons for updating

  • Addition of information on reporting a side effect.
  • Addition of black triangle

Updated on 22 September 2014

Reasons for updating

  • Addition of black triangle
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

-Black triangle included with the following text "This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions."$0-In section 4.8 details for the reporting of suspected adverse reactions has been edited;$0"Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel:+353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie."

Updated on 18 February 2014

Reasons for updating

  • Addition of information on reporting a side effect.
  • Addition of black triangle

Updated on 10 February 2014

Reasons for updating

  • Addition of black triangle
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

$01. Addition of black triangle$0$0$0$02. section 4.8: addition of information regarding the reporting of suspected adverse reactions

Updated on 05 March 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about driving or using machinery
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 08 October 2012

Reasons for updating

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

$0Section 4.1 $0$0Change in indication: Vastarel 20mg is nowonly indicated in adultsas add-on therapy for the symptomatic treatment of patients with stable anginapectoris who are inadequately controlled by or intolerant to first-line anti-anginaltherapies. $0$0Section 4.2 $0$0The recommended dose is now statedas “one tablet of 20mg oftrimetazidine three times a day during meals. “ Specific information has been added ontrimetazidine use in patients with renal impairment, use in elderly patientsand in paediatric populations. $0$0Section 4.3$0$0Vastarel is now also contraindicatedin Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome,and other related movement disorders and in severe renal impairment (creatinineclearance < 30ml/min).$0$0Section 4.4 $0$0Special warnings have been addedregarding the occurrence of parkinsoniansymptoms and movements disorders and regarding the use of trimetazidine inpatients with moderate renal impairment and in elderly patients over the age of75 yrs.$0$0Section 4.7$0$0New information has been added regardingeffects on ability to drive anduse machines. $0$0Section 4.8 $0$0A table of undesirable effects has beencreated. Several new side effects have been added.$0$0Section 5.1$0$0Information has been added regarding mechanismof action, pharmacodynamic effects and clinical efficacy and safety.$0

Updated on 04 March 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

Change in date of revision of text from September 2007 to January 2008

Updated on 03 December 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision
  • Change to improve clarity and readability
  • Change of special precautions for disposal

Updated on 18 February 2008

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Changes to sections 4.1, 4.4, 4.6 and 4.8

Updated on 05 June 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Product Authorisation renewal in April 2007.

Updated on 05 June 2007

Reasons for updating

  • Change to date of revision

Updated on 20 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 June 2003

Reasons for updating

  • New SPC for medicines.ie

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