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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: 07/03/2012
SPC Salofalk 4g/60ml Enema

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 07/03/2012 and displayed until Current
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-Feb-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 Feb 2012
Updated on 18/05/2011 and displayed until 07/03/2012
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 4.6 - 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 - Pharmacological properties
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
This SmPC has been updated in full to be in line with more up-to-date information available for the recently approved 1g Suppository.
Updated on 12/05/2010 and displayed until 18/05/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4 - Clinical particulars
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Section 1:  Added ‘4g/60ml’ to name and throughout corrected ‘4g/60g’ to ‘4g/60ml’.

Section 2:  Added ‘60g= 60ml’; added ‘Excipients:  Sodium Benzoate and Potassium metabisulphite’

Section 3:  Added ‘Enema’ to the form
Section 4.8:  Added peripheral neuropathy and reversible oligospermia

Section 5.3:  Added standard text:  Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Section 6.1:  Corrected Sodium bisulphate to Sodium metabisulphite

Section 6.6:  Added ‘shake well before use’

Section 10:  Changed to April 2010
Updated on 26/07/2007 and displayed until 12/05/2010
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:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Addition of cholestatic hepatitis 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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Active Ingredients

 
  Mesalazine