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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: 06/09/2010
SPC Salofalk 250mg Tablets

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 06/09/2010 and displayed until Current
Reasons for adding or updating:
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 2 and 3:  Updated to provide the information and wording required by the QRD template.
Section 4.2:  Current information re-worded to improve clarity.  Information for use in children added. The section "General instructions for use" added.
Section 4.3:  Added contraindication concerning hypersensitivity to the ingredients.  Removed all other contraindications except hepatic and renal impairment.
Sections 4.4, 4.5 and 4.6:  Extensive modifications to provide more up to date information.
Section 4.7: Reworded for clarity
Section 4.8: Extensive update and inclusion of frequencies.
Section 4.9: Extensive modifications to provide more up to date information
Section 5:  Fully updated to provide latest information.
Section 6.2, 6.3, 6.4, 6.5 and 6.6:  Reworded for clarity and in accordance with QRD template
Section 10: Updated date of revision to September 2010.
Updated on 01/06/2010 and displayed until 06/09/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 Posology and method of administration:  Added text concerning use in children
Section 4.3 Contraindications:  Removed text concerning use in children

Section 10 Revision date:  Updated
Updated on 17/09/2009 and displayed until 01/06/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   30-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change from Interfalk Ltd to Dr Falk Pharma Ltd
Updated on 08/09/2008 and displayed until 17/09/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 1.0 The name of the medicinal product has been changed from Salofalk Tablets to Salofalk 250mg Tablets
Updated on 09/08/2007 and displayed until 08/09/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • 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:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Peripheral neuropathy and cholestatic hepatitis has been added to section 4.8. The excipient Dibutyl phthalate has been removed from section 6.1.
Updated on 13/09/2006 and displayed until 09/08/2007
Reasons for adding or updating:
  • Change from BAN to rINN
Date of revision of text on the SPC:   03/2004
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The reference to sulphasalazine has been changed to sulfasalazine in sections 4.6 and 4.8
Updated on 29/09/2005 and displayed until 13/09/2006
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

 
  mesalazine