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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: 06/03/2012
SPC Salofalk 1g/actuation Rectal Foam

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 06/03/2012 and displayed until Current
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 4.8 - 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", "gastrointestinal disorders"and "General disorders and administration site conditions"
4.9 Overdose - new advice
10  Approved Jan 2012
Updated on 22/11/2010 and displayed until 06/03/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - added emphasis to use the product at room temperature
Section 10 - updated revision date
Updated on 01/06/2010 and displayed until 22/11/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 7 - Marketing Authorisation Holder
  • 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 - Updated text concerning use in children
4.3 - Removed contraindication on use in children
7 - Rremoved Box number
10 - Updated revision date
Updated on 14/09/2009 and displayed until 01/06/2010
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 11 - Dosimetry
  • Change to section 12 - Instructions for preparation of Radiopharmaceuticals
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   31-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


2.         Qualitative and quantitative composition

Added excipients as per QRD template.

 

4.8       Undesirable effects

Tabulated presentation.

 

6.4       Special precautions for storage

Added “incandescent material” and “temperatures over 50°C” as situations to be avoided.

 

6.6       Instructions for use and handling

Added “Any unused product waste material should be disposed of in accordance with local requirements”.

 

9.         Date of first authorisation/renewal of authorisation

Added renewal date.

 

10.       Date of (partial) revision of the text

Updated date.

 

Sections 11 and 12 deleted.
Updated on 09/08/2007 and displayed until 14/09/2009
Reasons for adding or updating:
  • 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:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Peripheral neuropathy and oligospermia has been added to section 4.8.
Updated on 30/09/2005 and displayed until 09/08/2007
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