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Dr. Falk Pharma UK Ltd
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 Fax: +44 (0)1628 536 601
Out of Hours Telephone: 0776 5004 275
Out of Hours Telephone: 0776 5403 015

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 07/02/2012
SPC Ursofalk 250mg Hard Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 07/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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:   02-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 Posology - The dosage for dissolution of gallstones has been changed to once daily.

Section 5.1 Pharmacotherapeutic group/ATC code has been added - ATC code: A05AA02 and A05B

Section 6.1 List of excipients - sodium lauryl sulphate was missed off the listing. This has now been corrrected. 

Section 10 - Date of Revision fo Text - updated to 2 February 2012
Updated on 18/10/2011 and displayed until 07/02/2012
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   09-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 20/09/2011 and displayed until 18/10/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The SPC has received a complete rewrite.

In particular, 
Section 1 
The product name has changed to Ursofalk 250mg Hard Capsules

 Section 4.2 
The posology for Primary Biliary Cirrhosis has changed to once daily dosing. 

 

Sections 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9These sections have been extensively changed to include the lastest information.

 

 

 
Updated on 29/09/2005 and displayed until 20/09/2011
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  ursodeoxycholic acid