Sabril 500mg film-coated tablets

  • Name:

    Sabril 500mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Vigabatrin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/01/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 24/12/2019

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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 16 January 2020 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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 24 December 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 5 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Free text change information supplied by the pharmaceutical company

Update from Word to PDF doc

Updated on 12 June 2018 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 4.8 - 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

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

Free text change information supplied by the pharmaceutical company

Section 4.4

Older people and patients with renal impairment

Added:-

  • Interactions to be taken into account
  • The concomitant use of vigabatrin and clonazepam may exacerbate the sedative effect (see section 4.5). Need for concomitant use must be carefully assessed.

Section 4.5 Interaction with other medicinal products and other forms of interaction

Added into section

  • The concomitant use of vigabatrin and clonazepam may exacerbate the sedative effect (see section 4.4).

Section 4.8  Undesirable effects

Added into table

  • Insomnia
  • Alopecia

Reporting of suspected adverse reactions

Amended:-

  • 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 12 June 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 19 October 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 October 2016 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Update Section 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2

Updated on 15 September 2014 SmPC

Reasons for updating

  • 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 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Many sections updated in line with the Quality Review Document version 9 with minor wording changes e.g. 'drugs' to 'medicinal products' (sections 2, 4.1. 4.3, 4.5, 4.7, 5.3

Section 4.2: Recommended dosage to include 'neonates' and adolescents'.
Section 4.4: Additional text under 'Suidical ideation and behaviour' - 'and the available data do not exclude the possibility of an increased risk for vigabitrin.'
Section 4.6: Whole section updated.
Section 4.8: Adverse reactions tabulated and the new PV Legislation wording on adverse effect reporting included.  'Vomiting' included.
Section 5.1: New headings 'Mechanism of action' and 'Clinical efficacy and safety'.
Section 5.2: 'Absorption' - new text 'Time to reach maximum plasma concentrations (tmax) is approximately 1 hour.'
'Distribution' - new text 'Binding to plasma proteins is negligible'.
'Biotransformation' - paragraph moved under 'Elimination'.
'Elimination' - some text moved to 'Biotransformation'.
New paragraph - 'Paediatric population'.
Section 6.3: shelf-life reduced from 5 to 3 years.
Section 6.6: Title updated to include 'and other handling'.


Updated on 10 September 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 September 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 8 January 2013 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Bulk Type IB No. C.I.3.a variation to implement changes to the agreed wording for which no new data are submitted by the MAH.  This variation was requested by the Finnish regulatory authority (RMS) following a PSUR work-sharing procedure (FI/H/PSUR/0024/003). Update to section 4.4. Deletion of 'central visual acuity is not impaired'.

Updated on 7 September 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7 updated with 'Sanofi' as a trading style

Updated on 5 September 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 17 November 2010 PIL

Reasons for updating

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

Updated on 9 August 2010 PIL

Reasons for updating

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

Updated on 29 June 2010 SmPC

Reasons for updating

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

To update sections 4.4 & 4
  • Cases of abnormal brain MRIs findings have been reported, in particular in young infants treated for infantile spasms with high doses of vigabatrin. MRI abnormalities and movement disorders
  • Reports of movement disorders including dystonia, dyskinesia and hypertonia in patients treated for infantile spasms

Updated on 26 March 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 20 March 2009 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Update Section  4.4 of SPC

Updated on 10 October 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 18 December 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2007 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

Update sectrion 4.4, 4.5, 4.6, 4.8

Updated on 15 March 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

Name, date of renewal and date of revision of SPC

Updated on 26 January 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 June 2004 SmPC

Reasons for updating

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

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

Updated on 19 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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