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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: 04/04/2012
SPC Salofalk 500mg gastro-resistant prolonged-release granules

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 04/04/2012 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. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Addition of 3g strength option.  Addition that when taken once daily, ideally it should be in the morning.  Addition that duration of treatment is determined by the physician.
Section 5.1 - Updated the pharmacotherapeutic group.
Section 6.5 - Added weight of granules in each sachet.
General minor, typographical changes throughout.
Updated on 06/03/2012 and displayed until 04/04/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   01-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.3 Contraindications - removed contraindications relating to ulcers and haemorrhagic diathesis
4.5 Interactions - removed majority of contraindications.  Added contraindications relating to thioguanine and warfarin.
4.8 Undesirable effects - added effects under "cardiac disorders", Respiratory, thoracic and mediastinal disorders" and "gastrointestinal disorders"
4.9 Overdose - new advice
10  Approved Jan 2012
Updated on 29/11/2010 and displayed until 06/03/2012
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-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - updated information for maintenance of remission
Section 4.3 - remove contraindications "pre existing gastric or duodenal ulcer" and "haemorrhagic diathesis"
Section 10 - updated revision date
Updated on 21/06/2010 and displayed until 29/11/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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


4.2  Posology and method of administration

Updated information concerning use in children.

 

4.4  Special warnings and precautions for use

Deleted statement concerning use in children.

 

10  Date of revision of the text

Updated date
Updated on 22/01/2008 and displayed until 21/06/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to add once daily dosage for acute treatment ulcerative colitis.
Updated on 09/08/2007 and displayed until 22/01/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
"In sachets" has been removed from the name of the product, peripheral neuropathy and oligospermia has been added to section 4.8.
Updated on 13/09/2006 and displayed until 09/08/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
cholestatic hepatitis has been added to section 4.8
Updated on 30/09/2005 and displayed until 13/09/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/09/2005 and displayed until 30/09/2005
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