Telfast 180mg Tablets

Product Information *

  • Company:

    SANOFI
  • 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 30 June 2021

File name

1.3.1.3 Telfast180mg-patient leaflet_1625058808.pdf

Reasons for updating

  • Change to name of medicinal product

Updated on 11 June 2021

File name

telfast 180mg IE PL 812368 (8)_1623410605.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 11 June 2021

File name

1.3.1 Telfast 180mg Film-coated tablets SmPC_1623409822.pdf

Reasons for updating

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

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

Updated on 02 September 2020

File name

ie-telfast180mg-patient leaflet_1599053831.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 06 July 2020

File name

PIL_8422_924.pdf

Reasons for updating

  • XPIL Removed

Updated on 10 June 2019

File name

SPC Telfast 180mg IE674 _1560164541.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

Section 4.6 of the SPC has been updated (please email me if you wish to view the highlighted SPC) with the additional text:

Fertility

No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatment (see section 5.3).

 

Updated on 08 December 2017

File name

PIL_8422_924.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 December 2017

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 14 July 2015

Reasons for updating

  • Change to further information section

Updated on 12 August 2014

Reasons for updating

  • Change to marketing authorisation holder

Updated on 25 April 2014

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 December 2013

Reasons for updating

  • New SPC for new product

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

Updated on 13 December 2013

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 4.6 - 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

Type IB Bulk - Update SPC in line with Art 45 worksharing procedure v97. Mutual Recognition Procedure number: UK/H/0151/003-005/IB/097/G

Updated on 26 June 2013

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5 updated with additional PVC/PVDC aluminium blister pack

Updated on 14 January 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Update to section 3 regarding a type IB bulk update to the SPC.

Updated on 23 November 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

 Type IA-IN Bulk -  MAH name PO and IE trading style

Updated on 06 May 2010

Reasons for updating

  • Change of manufacturer

Updated on 24 August 2009

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

Change from paranoia to paroniria. Typographical error.

Updated on 21 May 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 04 July 2008

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

Update section 7 and section 10

Updated on 19 May 2008

Reasons for updating

  • Improved electronic presentation

Updated on 24 August 2007

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

Update section 9 & 10 - Dates of renewal and revision

Updated on 02 May 2007

Reasons for updating

  • 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

Update Section 6.6 - Additional sub heading

Updated on 02 May 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 -
 2 - Administrative
4.3 - Addition of statement on excipients
4.4 - Warning on people suffering from cardiovascular disease
4.8 - Addition of tachycardia, palpatations, diarrhoea
4.9 - Addition of fatigue
6.2 - Administrative
6.4 - Administrative
6.5  - Administrative
10 - Date of revision

Updated on 19 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 07 October 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Updated on 18 July 2005

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)

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 June 2003

Reasons for updating

  • New SPC for medicines.ie

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