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Fludrocortisone acetate 0.1mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Fludrocortisone Acetate

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

Updated on 23 July 2024

File name

ie-pl-pr2677327-clean - rtq #3.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 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 23 July 2024

File name

ie-spc-pr2677327-clean - rtq #3.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 July 2023

File name

ie-spc-pr2786083-rtq2-clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 January 2021

File name

ie-spc-clean-ib-pr2320201.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 not be renewed (A)

Updated on 11 January 2021

File name

ie-pl-clean-ib-pr2320201.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 08 October 2019

File name

Flud_Tab_IE_S_0.1mg_Aug2017_v6.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 September 2017

File name

PIL_16325_389.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 April 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - warnings and precautions

Updated on 17 January 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 31 August 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 23 December 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to product name

Updated on 18 May 2015

Reasons for updating

  • New PIL for medicines.ie