Telfast 180mg Tablets
Product Information *
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SANOFIStatus:
UpdatedActive 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
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
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
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
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
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
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
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
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
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)