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

Summary of Product Characteristics last updated on the eMC: 16/03/2011
SPC Salofalk Enema 2g

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 16/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
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

Updated according to current template. No change in actual information

 

4.3       Contraindications

Typographical/grammatical updates and addition of  warning concerning potential hypersensitivity to  excipients.

4.4       Special warnings and precautions for use

Updated in full in line with the more up to date Salofalk 1g Suppository information.

4.5       Interaction with other medicinal products and other forms of interaction

Updated in full in line with the more up to date Salofalk 1g Suppository information.

4.6       Pregnancy and lactation

Updated in full in line with the more up to date Salofalk 1g Suppository information.

4.7       Effects on ability to drive and use machines

Updated to standard phrase; no actual change.

4.8       Undesirable effects

Updated in full in line with the more up to date Salofalk 1g Suppository information.

4.9       Overdose

Updated in full in line with the more up to date Salofalk 1g Suppository information.

 

 

5.1       Pharmacodynamic properties

Updated in full in line with the more up to date Salofalk 1g Suppository information.

5.2       Pharmacokinetic properties

Updated in full in line with the more up to date Salofalk 1g Suppository information.

5.3       Preclinical safety data

Updated in full in line with the more up to date Salofalk 1g Suppository information.

 

6.1       List of excipients

Typographical updates.

 

10        Date of revision of the text

Added date of approval

Updated on 24/05/2010 and displayed until 16/03/2011
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-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.2:  Updated text regarding use in children

Section 10:   Updated revision date

Updated on 09/08/2007 and displayed until 24/05/2010
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 13/09/2006 and displayed until 09/08/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
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