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Dr. Falk Pharma UK Ltd
Unit K, Bourne End, Business Park, Cores End Road, Bourne End, Buckinghamshire, SL8 5AS
Telephone: +44 (0)1628 536 600
Fax: +44 (0)1628 536 601
Medical Information Direct Line: +44 (0)1628 536 616
Customer Care direct line: +44 (0)1628 536 600
Medical Information Facsimile: +44 (0)1628 536 601
Summary of Product Characteristics last updated on medicines.ie: 23/05/2011
SPC Ursofalk 250mg Hard Capsules

When a pharmaceutical company changes an SPC or PIL, 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 23/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   13-May-2011
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 06/12/2010 and displayed until 23/05/2011
Reasons for adding or 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
Date of revision of text on the SPC:   28-Oct-2010
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 14/01/2010 and displayed until 06/12/2010
Reasons for adding or 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
Date of revision of text on the SPC:   30-Nov-2009
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 10/10/2006 and displayed until 14/01/2010
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ursodeoxycholic Acid