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Ursofalk 250mg Hard Capsules

*
Pharmacy Only: Prescription

  • Company:

    DR. FALK PHARMA GMBH

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Ursodeoxycholic Acid

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

Updated on 15 November 2024

File name

Ursofalk-Capsules-SPC-Nov24-IE.pdf

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

To include urticaria and nausea / vomiting under “not known” frequency

Updated on 15 November 2024

File name

Ursofalk Capsules-PIL-November2024-IE.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

To include urticaria and nausea / vomiting under “not known” frequency

Updated on 19 January 2023

File name

Ursofalk-Capsules-SPC-Jul2015-IE.pdf

Reasons for updating

  • Document format updated

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

Free text change information supplied by the pharmaceutical company

Updated to HTML format

Updated on 19 January 2023

File name

Ursofalk-Capsules-SPC-Jul2015-IE.pdf

Reasons for updating

  • Document format updated

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

Free text change information supplied by the pharmaceutical company

Updated to HTML format

Updated on 23 February 2021

File name

Ursofalk-250mg-Capsules-Oct15 Joint-UKIE-PIL.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

Text edit only - no change to meaning

Updated on 13 January 2020

File name

Ursofalk-Capsules-SPC-Jul2015-IE.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

SmPC added back into the system as it was missing after previous system changes by IPHA.

Updated on 11 January 2016

File name

PIL_11599_102.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 January 2016

Reasons for updating

  • Change to drug interactions

Updated on 06 November 2015

Reasons for updating

  • New SPC for new product

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

Updated on 06 November 2015

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Preparation of combined UK/IE pack. 60 capsule pack listed on SmPC . Not all packs may be marketed.

Updated on 23 October 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 03 February 2015

Reasons for updating

  • Change to paediatric information
  • Change to section 4 - Clinical particulars
  • 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 4.5 - 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
  • 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

Updated template.
Additional paediatric indication.
Updated safety information.

Updated on 27 January 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 08 January 2013

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 21 December 2011

Reasons for updating

  • Change to dosage and administration
  • Correction of spelling/typing errors

Updated on 23 May 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

In section 4.2, The dosing for Primary Biliary Cirrhosis (PBC), following 3 month improvements in the liver values, has been changed to once daily in the evening.

Updated on 18 May 2011

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 06 December 2010

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Change to section 4.3 - Contraindications
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 4.7 - Effects on ability to drive and use machines 
Change to section 4.8 - Undesirable effects
Change to section 4.9 - Overdose
Change to section 10 - Date of revision of the text 

Updated on 14 January 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • 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

1.  Changed name from Ursofalk 250mg Capsules to Ursofalk 250mg Hard Capsules

2.  For excipients, see 6.1  changed to For a full list of excipients, see section 6.1.

6.1.  Added ‘Capsule Shell’ and changed Sodium dodecyl sulphate to Sodium laurilsulphate

10.  Updated revision date.

Updated on 07 January 2010

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 14 November 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 October 2006

Reasons for updating

  • New SPC for medicines.ie

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