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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: 04/10/2010
SPC Budenofalk 3mg gastro-resistant capsules

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 04/10/2010 and displayed until Current
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2.  Posology and method of administration

Details on paediatric use added.

 

4.4.  Special warnings and special precautions for use

Information on changing from systemically acting corticosteroids, particularly in adosescents.

 

4.8.  Undesirable Effects

Added section “Side effects in clinical studies with paediatric patients:“

 

 5.1  Pharmacodynamic properties

Added paediatric information.

 

5.2.  Pharmacokinetic Properties

Added section on Paediatric patients:

 

10  Date of Revision of the Text

Date revised
Updated on 08/09/2010 and displayed until 04/10/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.1 - Therapeutic indications
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


4.1.         Therapeutic indications  -  Addition of autoimmune hepatitis indication.

4.2.         Posology and method of administration  -  Addition of posology and duration of treatment for the autoimmune hepatitis indication.

4.3.         Contra-indications  -  Removed reference to portal hypertension.

4.8.         Undesirable Effects  -  Added reference to effects in paediatrics when taken for autoimmune hepatitis.

5.1.         Pharmacodynamic Properties  -  Added Clinical efficacy and safety information from clinical studies in patients with autoimmune hepatitis.

5.2.         Pharmacokinetic Properties  -  Updated the section:  Specific patient populations - Liver diseases.

10.          Date of (partial) revision of the text  -  Updated
Updated on 27/01/2010 and displayed until 08/09/2010
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Renewal date is 4/1/09. Both sections updated to reflect this date.
Updated on 17/09/2009 and displayed until 27/01/2010
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 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   30-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes are as follows:

2.    Qualitative and quantitative composition

Addition of excipients to comply with QRD template

 

4.4. Special warnings and special precautions for use

Added comment on systemic effects of corticosteroids

 

4.8. Undesirable Effects

Updated section on Psychiatric disorders to add “In addition very rarely a wide range of psychatric/behavioural effects may occur”

 

6.1. List of excipients

Added capsule shell ingredients
Updated on 09/08/2007 and displayed until 17/09/2009
Reasons for adding or updating:
  • 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:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Replacement of the excipient dibutyl phthalate with triethyl citrate.
Updated on 13/09/2006 and displayed until 09/08/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
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

 
  budesonide