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Telfast 180mg Tablets

  • Name:

    Telfast 180mg Tablets

  • Company:
    info
  • Active Ingredients:

    fexofenadine hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/12/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 10/6/2019

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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 10 June 2019 SmPC

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 8 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 December 2017 PIL

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 PIL

Reasons for updating

  • Change to further information section

Updated on 12 August 2014 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 25 April 2014 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 December 2013 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 December 2013 SmPC

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 SmPC

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 SmPC

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 SmPC

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 6 May 2010 PIL

Reasons for updating

  • Change of manufacturer

Updated on 24 August 2009 SmPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 4 July 2008 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

Update section 7 and section 10

Updated on 19 May 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 24 August 2007 SmPC

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 2 May 2007 SmPC

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 2 May 2007 SmPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 October 2005 SmPC

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 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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