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Sabril 500mg granules for oral solution

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Vigabatrin

    *Additional information is available within the SPC or upon request to the company

Updated on 08 March 2021

File name

Ireland Sabril Granules SmPC (1).pdf

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)

Updated on 01 February 2021

File name

Ireland Sabril Granules SmPC.pdf

Reasons for updating

  • 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

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

Updated on 01 February 2021

File name

1.3.2.1 Mock-up Leaflet - IE Granules.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 - 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
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 01 February 2021

File name

1.3.2.1 Mock-up Leaflet - IE Granules.pdf

Reasons for updating

  • 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

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

Updated on 06 July 2020

File name

1.3.2.1 Sabril 500mg Granules for Oral Solution PIL (1).pdf

Reasons for updating

  • XPIL Removed

Updated on 06 February 2020

File name

1.3.1.1 Ireland IE924 Sabril FIHxxxxWS58 500mg Granules SmPC CCDS v13 Approved 23-Dec-2019.pdf

Reasons for updating

  • Other

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

Free text change information supplied by the pharmaceutical company

The PIL was uploaded, replaced with SPC

Updated on 16 January 2020

File name

1.3.2.1 Sabril 500mg Granules for Oral Solution PIL (1).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 - 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 06 January 2020

File name

1.3.2.1 Sabril 500mg Granules for Oral Solution PIL.pdf

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

The following sections of the product information are updated in relation to visual acuity: 

• Update of Warnings/Precautions regarding tunnel vision and reduced visual acuity (SmPC Section 4.4 & PIL Section 2)

• Update of Adverse Reaction section, in which the wording “retinal disorder (such as peripheral disorders)” is updated to “retinal disorders (mainly peripheral)” (SmPC section 4.8 & PIL Section 4)

Updated on 24 December 2019

File name

Sabril 500mg Granules SmPC.pdf

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 05 June 2019

File name

Sabril 500mg granules for oral solution SmPC.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

Update from Word to PDF doc

Updated on 12 June 2018

File name

Sabril 500mg granules for oral solution SPC.docx

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

File name

Sabril 500mg granules PIL.pdf

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 16 September 2014

Reasons for updating

  • New SPC for new product

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

Updated on 16 September 2014

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 4.6 - 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 6.6 - Special precautions for disposal and other handling

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 6.6: Title updated to include 'and other handling'.

Updated on 10 September 2014

File name

PIL_9795_519.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 September 2014

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 08 January 2013

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 07 September 2012

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 05 September 2012

Reasons for updating

  • Change to marketing authorisation holder

Updated on 17 November 2010

Reasons for updating

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

Updated on 09 August 2010

Reasons for updating

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

Updated on 16 July 2010

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

Update section 4.4 and 4.8 of the SPC with regard to
  • 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

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 24 March 2009

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

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 19 December 2007

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 Section 4.4, 4.5, 4.6, 4.8

Updated on 18 December 2007

Reasons for updating

  • Improved electronic presentation

Updated on 15 March 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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, pharmaceutical form, date of renewal and date of revision of SPC.

Updated on 15 March 2007

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

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

Reasons for updating

  • Improved electronic presentation

Updated on 04 September 2006

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

Update section 10 - administrative

Updated on 23 May 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 June 2004

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 11 June 2003

Reasons for updating

  • New SPC for medicines.ie

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