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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: 17/12/2010
SPC Salofalk Suppositories 500mg

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 17/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 date of revision of the text
  • Change to section 11 - Dosimetry
  • Change to section 12 - Instructions for preparation of Radiopharmaceuticals
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 2          QUALITATIVE AND QUANTITATIVE COMPOSITION

Reworded and updated in line with template.

 

4.3       Contraindications

Removed contraindication of ulcers.  Added hypersensitivity to excipients.

 

4.4       Special warnings and precautions for use

Updated in full in line with more recent information and with Salofalk 1g suppository.

 

4.5       Interaction with other medicinal products and other forms of interaction

Updated in full in line with more recent information and with Salofalk 1g suppository.

 

4.6       Pregnancy and lactation

Updated in full in line with more recent information and with Salofalk 1g suppository.

 

4.7       Effects on ability to drive and use machines

Changed to say no effects on ability to drive and use machines have been observed

 

4.8       Undesirable effects

Updated in full in line with more recent information and with Salofalk 1g suppository.

 

4.9       Overdose

Added use of intravenous infusion of electrolytes (forced diuresis) if necessary in cases of overdose.

 

5.1       Pharmacodynamic properties

Updated in full in line with more recent information and with Salofalk 1g suppository.

 

5.2       Pharmacokinetic properties

Updated in full in line with more recent information and with Salofalk 1g suppository.

 

5.3       Preclinical safety data

Updated in full in line with more recent information and with Salofalk 1g suppository.

 

10        DATE OF REVISION OF THE TEXT

Updated

 

11        DOSIMETRY (IF APPLICABLE)

Deleted

 

12        INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Deleted
Updated on 28/04/2010 and displayed until 17/12/2010
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:   01-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 Posology and Administration – information relating to children updated

 
Updated on 09/08/2007 and displayed until 28/04/2010
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:   08/2006
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 29/09/2005 and displayed until 09/08/2007
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