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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: 11/04/2012
SPC Salofalk 500mg gastro-resistant prolonged-release granules

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

Updated on 11/04/2012 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:   Product subject to medical prescription which may be renewed (B)

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 11/04/2012
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:   Product subject to medical prescription which may be renewed (B)

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 16/11/2010 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:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.2 - updated dosage 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 01/06/2010 and displayed until 16/11/2010
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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

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.

 

9  Date of first authorisation/renewal of the authorisation

Corrected date of authorisation

 

10  Date of revision of the text

Updated date
Updated on 04/09/2009 and displayed until 01/06/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Mar-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.5:  Added 500mg after Salofalk
Section 7:  Removed phone number
Section 9:  Corrected dates
Section 10:  Updated date
Updated on 16/01/2008 and displayed until 04/09/2009
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:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to add once daily dosage for acute treatment of ulcerative colitis.
Updated on 26/07/2007 and displayed until 16/01/2008
Reasons for adding or updating:
  • Change to section 1 - Name of 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:   prescription only

Free-text change information supplied by the pharmaceutical company

Removal of "in sachets" from the name of the product, peripheral neuropathy and oligospermia added to section 4.8.
Updated on 10/10/2006 and displayed until 26/07/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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